PeriodontitisNCT07472218
Periodontal Dressings in Non-Surgical Therapy
A study testing Ora Aid application and Coe-Pack application in people with Periodontitis and Periodontitis (Stage 3), run by Saglik Bilimleri Universitesi.
Trial summary
This study aims to evaluate and compare the efficacy of two different eugenol-free periodontal dressing materials-Ora-Aid (a hydrophilic polymer) and Coe-Pak (a zinc oxide-based paste)-following non-surgical periodontal treatment (scaling and root planing, SRP) in patients with Stage 3, Grade A periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontitis, Periodontitis (Stage 3), Periodontal Pocket
- What is being tested?
- Ora Aid application and Coe-Pack application
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy volunteers aged 18-45 years.
- Diagnosis of Periodontitis (Stage 3, Grade A).
- Presence of at least 20 permanent teeth.
- Capacity to understand the study protocol and provide informed consent.
Who cannot join
- Systemic diseases (e.g., Diabetes, Chronic Renal Failure, Cancer, Connective Tissue Disorders).
- Pregnancy or breastfeeding.
- Smoking (>10 cigarettes/day).
- Antibiotic use within the last 3 months or periodontal treatment within the last year.
- Presence of orthodontic appliances, removable prostheses, or extensive interproximal caries.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Effectiveness of Two Different Periodontal Wound Dressings in Non-Surgical Periodontal Therapy
This study aims to evaluate and compare the efficacy of two different eugenol-free periodontal dressing materials-Ora-Aid (a hydrophilic polymer) and Coe-Pak (a zinc oxide-based paste)-following non-surgical periodontal treatment (scaling and root planing, SRP) in patients with Stage 3, Grade A periodontitis. The study utilizes a split-mouth design to analyze clinical periodontal parameters, patient comfort, and microbiological changes over a 3-month period.
Read the detailed description
Scope:
Tooth surface cleaning and root surface planing are integral parts of non-surgical periodontal treatment to remove bacterial plaque and tartar from diseased root surfaces. Periodontal wound dressings began to be used in the early 19th century to protect periodontal wounds. These wound dressings provide protection in the treated area and, by remaining in close contact with the tissue and tooth, help stabilize the clot and protect it from external and internal forces during function. It has also been reported that tooth surface cleaning and root surface planing cause separation and structural damage in the lingual and buccal soft tissues. The use of periodontal dressings is recommended to improve the health of these damaged tissues and reduce patient discomfort.
The aim of this study is to analyze the clinical parameters, patient comfort, and microbiological benefits of different wound dressings used in dental calculus removal and root planing in the treatment of patients with periodontitis.
Topic: Periodontitis is a multifactorial, non-infectious disease that can lead to tooth loss if left untreated. Advanced stages of periodontitis can affect chewing ability, nutritional status, and quality of life.
Scaling, root planing, and mechanical removal of plaque should be considered a fundamental part of initial periodontal treatment. Furthermore, in patients who participate in a regular maintenance program following scaling and root planing, less tooth loss and clinical attachment loss are observed. Scaling and root planing are an integral part of non-surgical periodontal treatment to remove bacterial plaque and calculus from diseased root surfaces.
Periodontal wound dressings began to be used in the early 19th century to protect periodontal wounds. These wound dressings provide protection in the treated area and, by remaining in close contact with the tissue and tooth, help stabilize the clot and protect it from external and internal forces during function. It has also been reported that tooth surface cleaning and root planing procedures cause separation and structural damage in the lingual and buccal soft tissues. The use of periodontal dressings is recommended to improve the health of these damaged tissues and reduce patient discomfort.
Coe-Pak is the most commonly used eugenol-free intraoral wound dressing. It consists of two pastes: the base paste contains zinc oxide with added oils and gums, and lorothidol, a fungicide related to hexachlorophene. The catalyst paste contains colophony resin or resin and coconut fatty acids thickened with chlorothymol as an antibacterial agent. Materials of equal length are placed on a waxed paper pad and mixed using a wooden spatula until a thick consistency and uniform color are achieved. The reaction time can be altered by adding a few drops of warm water during mixing or by dipping the package into a container of warm water immediately after mixing. When the paste loses its stickiness, it can be transferred to the patient's mouth using gloves moistened with water and placed in a thin layer over the affected teeth.
Ora-Aid is an eugenol-free dental wound dressing introduced for use by dentists in 2017 by TBM (Technological Bio-Materials). Developed as a hydrophilic polymer, Ora-Aid does not have adhesive strength when first opened, but reacts within 3-5 seconds when it comes into contact with oral fluid and forms a strong adhesive bond. Ora-Aid can be used for various purposes in dental clinics. It can be used after implants and tooth extractions, after periodontology procedures, for wounds in the mouth after orthodontics, and for other wounds in the mouth. When applied, it protects the area from food, bacteria, and cigarette smoke. It prevents secondary infections. It stops bleeding and significantly reduces the patient's pain. Ora-Aid is slowly absorbed in the mouth and is resorbed within a certain time depending on oral activity. Ora-Aid is a CE-certified product with a TUS registration. It consists of hydrophilic high polymer materials containing raw materials compliant with the Korean Pharmacopoeia and USP (US Patent) standards and vitamin E. There are no contraindications for its absorption and swallowing. Its mint aroma enhances the feeling of freshness in the mouth.
The aim of our study is to evaluate the patient comfort, effect on clinical periodontal parameters, and microbiological efficacy of periodontal wound covering materials used during non-surgical periodontal treatment in patients with periodontitis.
Method Study Group (Total n=25): A split-mouth study design was planned for the same patient. The right or left upper and lower jaws of the patients will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth tooth surface cleaning and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the periodontal dressings are in place. Patients' wound dressings will be removed after 1 week.
Patients who applied to the Department of Periodontology, Gülhane Dental School, Health Sciences University, and were diagnosed with periodontitis (Stage 3-Grade A) during the clinical examination and underwent routine non-surgical periodontal treatment will be included in the study if they voluntarily agree to participate. Patients who have used antibiotics in the last 3 months, patients who have undergone periodontal treatment in the last 6 months, patients with systemic diseases, patients who smoke, patients with pain, patients with interproximal caries, patients using orthodontic appliances and/or removable prostheses, and patients who are pregnant or breastfeeding will not be included in the study. Participants will be advised not to use any medications during the study period.
At baseline and at 1 and 3 months after treatment, patients' Gingival Indices⁶ (GI/ Loe and Silness Gingival index), Plaque Indices⁷ (PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index), and Papillary Bleeding Indices⁸ (PBI/ Saxer et al.) and Bleeding on Probing Indexes9 (BOP), Probing Pocket Depth10 (SCD), and Clinical Attachment Loss11 (CAL) will be recorded. At the start of treatment and 1 month after treatment, plaque samples will be collected from the deepest pockets on the right and left sides, and the total bacterial load will be compared.
Clinical follow-ups to be performed by the physician
Clinical Records:
The patient's age, gender, and systemic diseases will be recorded. Upon the patient's first visit, all oral clinical indices will be taken, and plaque samples will be collected from the deepest pathological pockets.
The form used for diagnosis for every patient who comes to our clinic is provided in the attachment. The indices to be checked during the examination are listed below.
Gingival Index (GI, Löe \& Silness, 1963, 1967) This index was developed by Löe and Silness in 1963 and modified by various researchers in 1967. In this system, bleeding, the most fundamental sign of inflammation, is evaluated. The mesial, distal, vestibular, and lingual gingivae of the teeth are evaluated. These values are then added together and divided by four. This is how the gingival index is calculated. Dividing the sum of the values by the number of teeth gives the individual's score.
Gingival Index Values
- 0 Healthy gums, no inflammation.
- 1 Mild inflammation, discoloration, and slight edema in the gums, no bleeding on probing.
- 2 Moderate inflammation, redness, and edema in the gums, bleeding on probing.
- 3 Severe inflammation, redness, and edema in the gums, spontaneous bleeding is observed.
Papilla Bleeding Index (PBI, Saxer \& Mühleman, 1975) Bleeding in the gingival papilla is assessed by probing. Probing is performed on 4 half-jaws. However, to ensure that the assessment reflects the inflammation of all papillae and to facilitate the procedure, the assessment is performed on the papillae on the facial surfaces of the teeth in the right upper and left lower jaws on the oral side, and in the left upper and right lower jaws on the buccal side. The values found are then divided by the total number of papillae to find the average papillary bleeding index value. This index is very important in terms of patient motivation. Patients who see bleeding in their gums can easily identify the diseased area in their mouth and develop positive behaviors in applying the oral care procedures they have been taught.
Papillary Bleeding Index Values
- 0 No bleeding.
- 1 There is slight bleeding 20 seconds after probing.
- 2 There is linear bleeding in the papilla area after probing.
- 3 There is bleeding that fills the interdental area after probing.
- 4 Excessive bleeding overflowing from the interdental area after probing. Plaque Index(PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index) Investigates the amount of plaque on the facial and lingual surfaces using a plaque-disclosing agent. The total score is divided by the number of surfaces examined, and the index score for the individual is determined.
The plaque-disclosing agent (Tri Plaque ID GelTM, GC Dental, USA) is applied to all tooth surfaces using a fine-tipped brush.
Areas on the tooth surfaces stained pink, purple, or blue are scored from 0 to 5 (Score 0: no plaque, 1: isolated plaque patches at the gingival margin, 2: plaque in a thin band at the gingival margin, 3: plaque covering less than 1/3 of the tooth surface, 4: plaque covering no more than 2/3 of the tooth surface, 5: plaque covering more than 2/3 of the tooth surface). The entire mouth is divided into 6 different areas, and the average TQHPI values of the participants are calculated by taking the mathematical ratio of the values obtained from the mesial, distal, lingual, and vestibular surfaces of specific teeth in each sextant.
Bleeding on Probing Index ( Ainamo \& Bay, 1976) In this index, probing and bleeding are evaluated by gently probing the pocket. The evaluation is based on the presence or absence of bleeding in the gums as a result of probing. If bleeding occurs within 10-15 seconds after probing all teeth in the mesial, distal, vestibular, and lingual gingival sections, a positive value is given. The ratio of the bleeding area to the examined area is expressed as a percentage.
Probable pocket depth Probable pocket depth, or probing depth, is a numerical value obtained by measuring the distance between the gingival margin and the gingival sulcus/pocket base using a standard periodontal probe with a tip diameter of approximately 0.4-0.5 mm and rounding to the nearest mm.16 Clinical Attachment Loss (CAL): This is the value obtained by measuring the distance between the pocket base and the enamel-cementum junction using a standard periodontal probe with a diameter of 0.4-0.5 mm and rounding it to the nearest mm.
Postoperative records Clinical indices will be taken before periodontal treatment, at 1 month, and at 3 months.
Form Appendix -D has been created for clinical follow-ups to be performed by the physician.
Microbiological examination:
Plaque samples taken from each patient for microorganism quantification will be stored in Eppendorf tubes at -80°C with sterile distilled water until microbial analysis.
Plaque samples stored at -80°C in Eppendorf tubes will be transported in dry ice thermal storage bags by personal vehicle to the laboratories of Kırklareli University Faculty of Medicine, where microbiological examination will be performed.
DNA isolation will be performed from all suture samples using High Pure PCR Template (Roche Diagnostics GmBH, Mannheim, Germany) according to the manufacturer's instructions. DNA will be stored at 80°C until the process is completed.
The 16S rRNA gene will be detected by qPCR, and the total amount of bacteria will be determined. The 16S rRNA gene will be amplified using primers specific to the 16S rRNA gene: 50-TCCTACGGGAGCACAGT-30 and 50-GGACTACCAGG GTATCTAATCCTG T-30. To establish a standard curve for quantification, 16S-specific plasmids with known values will be obtained from Bioeksen (Istanbul, Turkey). Real-time PCR procedures will be performed on the LightCycler 480 II system using the Fast Start Essential DNA Green Master Mix Kit (Roche Diagnostics, Mannheim, Germany) according to the manufacturer's instructions. The analysis will be performed in a total volume of 20 mL with 5 mL of template DNA and 15 mL of master mix. The real-time PCR (qPCR) protocol will consist of enzyme activation at 95°C for 10 minutes; 40 PCR cycles (single read) at 95°C for 20 seconds, 60°C for 20 seconds, and 72°C for 15 seconds; and 10 seconds at 95°C, followed by 1 minute at 65°C for melting curve analysis, and continuous reading at 95°C.
- Conditions
- Periodontitis, Periodontitis (Stage 3), Periodontal Pocket
- Being tested
- Ora Aid application, Coe-Pack application
- Keywords
- periodontitis, Non-surgical periodontal therapy, Periodontal dressing, Ora-Aid, Coe-Pak, total bacterial load
- Medical subject headings
- Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ora Aid applicationProcedure or surgery
Baseline: Comprehensive periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) will be recorded. Subgingival plaque samples will be collected from the deepest periodontal pockets for microbiological analysis.
Intervention: Following full-mouth scaling and root planing (SRP), Ora-Aid or Coe-Pak dressings will be applied to the designated quadrants.
1-Week Follow-up: Periodontal dressings will be professionally removed from all treated sites.
1-Month Follow-up: Periodontal clinical indices will be re-evaluated. Plaque samples will be collected from the same initial sites to determine changes in total bacterial load via qPCR.
3-Month Follow-up: Final periodontal clinical measurements will be recorded to assess long-term treatment efficacy and clinical attachment gains.
Coe-Pack applicationProcedure or surgery
Baseline: Comprehensive periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) will be recorded. Subgingival plaque samples will be collected from the deepest periodontal pockets for microbiological analysis.
Intervention: Following full-mouth scaling and root planing (SRP), Ora-Aid or Coe-Pak dressings will be applied to the designated quadrants.
1-Week Follow-up: Periodontal dressings will be professionally removed from all treated sites.
1-Month Follow-up: Periodontal clinical indices will be re-evaluated. Plaque samples will be collected from the same initial sites to determine changes in total bacterial load via qPCR.
3-Month Follow-up: Final periodontal clinical measurements will be recorded to assess long-term treatment efficacy and clinical attachment gains
| Study group | Role | What they receive |
|---|---|---|
| Ora-aid side | Experimental | A split-mouth study design has been planned for the same patient. The patient's right or left upper and lower jaws will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth scaling and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the dressings are in place. The wound dressings will be removed after 1 week. Receives: Procedure: Coe-Pack application |
| Coe-pack side | Experimental | A split-mouth study design has been planned for the same patient. The patient's right or left upper and lower jaws will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth scaling and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the dressings are in place. The wound dressings will be removed after 1 week. Receives: Procedure: Ora Aid application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
PPD will be measured at six sites per tooth using a calibrated periodontal probe. The mean value per patient will be calculated. A decrease in PPD indicates clinical improvement.
Unit of Measure: Millimeters (mm)
Measured: Baseline, 1st and 3rd months
total bacterial load
This study involves the longitudinal comparison of total bacterial load, assessed via plaque samples collected from the deepest periodontal pockets on both the right and left sides at baseline, 1 month, and 3 months post-treatment.
Measured: baseline, 1 month, and 3 months
Secondary outcomes (4)
Evoluation of Gingival Index (GI)
Gingival inflammation will be assessed using the Loe and Silness Gingival Index. Scores range from 0 to 3 (0 = Normal gingiva; 3 = Severe inflammation, ulceration, tendency to spontaneous bleeding).
Unit of Measure: Units on a scale (Score 0-3)
Measured: Baseline, 1st and 3rd months.
Plaque Index (PI) Scores
Oral hygiene status will be assessed using the Silness and Loe Plaque Index. Scores range from 0 to 3 (0 = No plaque; 3 = Abundance of soft matter).
Unit of Measure: Units on a scale (Score 0-3)
Measured: Baseline, 1 month, 3 months.
Percentage of Sites with Bleeding on Probing (BOP)
Presence or absence of bleeding will be recorded within 30 seconds after probing. The result will be expressed as the percentage of total sites that bleed.
Unit of Measure: Percentage of sites (%)
Measured: Baseline, 1 month, 3 months.
Change in Clinical Attachment Loss (CAL)
CAL is measured as the distance from the cemento-enamel junction to the bottom of the periodontal pocket. The mean value per patient will be recorded.
Unit of Measure: Millimeters (mm)
Measured: Baseline, 1 month, 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Group (Total n=25): A split-mouth study design was planned for the same patient. The right or left upper and lower jaws of the patients will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth tooth surface cleaning and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the periodontal dressings are in place. Patients' wound dressings will be removed after 1 week. Patients who applied to the Department of Periodontology, Gülhane Dental School, Health Sciences University, and were diagnosed with periodontitis (Stage 3-Grade A) during the clinical examination and underwent routine non-surgical periodontal treatment will be included in the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEVAL CEYLAN ŞEN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472218
- Sponsor's protocol ID
- Seval 3
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision has not yet been made regarding the sharing of individual participant data. The decision will be finalized upon the completion of the study and publication of the primary results
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Two Different Periodontal Wound Dressings in Non-Surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT07472218
- Acronym / sponsor ID
- Seval 3
- Conditions
- Periodontitis, Periodontitis (Stage 3), Periodontal Pocket
- Keywords
- periodontitis, Non-surgical periodontal therapy, Periodontal dressing, Ora-Aid, Coe-Pak, total bacterial load
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate and compare the efficacy of two different eugenol-free periodontal dressing materials-Ora-Aid (a hydrophilic polymer) and Coe-Pak (a zinc oxide-based paste)-following non-surgical periodontal treatment (scaling and root planing, SRP) in patients with Stage 3, Grade A periodontitis. The study utilizes a split-mouth design to analyze clinical periodontal parameters, patient comfort, and microbiological changes over a 3-month period.
Detailed description
Scope:
Tooth surface cleaning and root surface planing are integral parts of non-surgical periodontal treatment to remove bacterial plaque and tartar from diseased root surfaces. Periodontal wound dressings began to be used in the early 19th century to protect periodontal wounds. These wound dressings provide protection in the treated area and, by remaining in close contact with the tissue and tooth, help stabilize the clot and protect it from external and internal forces during function. It has also been reported that tooth surface cleaning and root surface planing cause separation and structural damage in the lingual and buccal soft tissues. The use of periodontal dressings is recommended to improve the health of these damaged tissues and reduce patient discomfort.
The aim of this study is to analyze the clinical parameters, patient comfort, and microbiological benefits of different wound dressings used in dental calculus removal and root planing in the treatment of patients with periodontitis.
Topic: Periodontitis is a multifactorial, non-infectious disease that can lead to tooth loss if left untreated. Advanced stages of periodontitis can affect chewing ability, nutritional status, and quality of life.
Scaling, root planing, and mechanical removal of plaque should be considered a fundamental part of initial periodontal treatment. Furthermore, in patients who participate in a regular maintenance program following scaling and root planing, less tooth loss and clinical attachment loss are observed. Scaling and root planing are an integral part of non-surgical periodontal treatment to remove bacterial plaque and calculus from diseased root surfaces.
Periodontal wound dressings began to be used in the early 19th century to protect periodontal wounds. These wound dressings provide protection in the treated area and, by remaining in close contact with the tissue and tooth, help stabilize the clot and protect it from external and internal forces during function. It has also been reported that tooth surface cleaning and root planing procedures cause separation and structural damage in the lingual and buccal soft tissues. The use of periodontal dressings is recommended to improve the health of these damaged tissues and reduce patient discomfort.
Coe-Pak is the most commonly used eugenol-free intraoral wound dressing. It consists of two pastes: the base paste contains zinc oxide with added oils and gums, and lorothidol, a fungicide related to hexachlorophene. The catalyst paste contains colophony resin or resin and coconut fatty acids thickened with chlorothymol as an antibacterial agent. Materials of equal length are placed on a waxed paper pad and mixed using a wooden spatula until a thick consistency and uniform color are achieved. The reaction time can be altered by adding a few drops of warm water during mixing or by dipping the package into a container of warm water immediately after mixing. When the paste loses its stickiness, it can be transferred to the patient's mouth using gloves moistened with water and placed in a thin layer over the affected teeth.
Ora-Aid is an eugenol-free dental wound dressing introduced for use by dentists in 2017 by TBM (Technological Bio-Materials). Developed as a hydrophilic polymer, Ora-Aid does not have adhesive strength when first opened, but reacts within 3-5 seconds when it comes into contact with oral fluid and forms a strong adhesive bond. Ora-Aid can be used for various purposes in dental clinics. It can be used after implants and tooth extractions, after periodontology procedures, for wounds in the mouth after orthodontics, and for other wounds in the mouth. When applied, it protects the area from food, bacteria, and cigarette smoke. It prevents secondary infections. It stops bleeding and significantly reduces the patient's pain. Ora-Aid is slowly absorbed in the mouth and is resorbed within a certain time depending on oral activity. Ora-Aid is a CE-certified product with a TUS registration. It consists of hydrophilic high polymer materials containing raw materials compliant with the Korean Pharmacopoeia and USP (US Patent) standards and vitamin E. There are no contraindications for its absorption and swallowing. Its mint aroma enhances the feeling of freshness in the mouth.
The aim of our study is to evaluate the patient comfort, effect on clinical periodontal parameters, and microbiological efficacy of periodontal wound covering materials used during non-surgical periodontal treatment in patients with periodontitis.
Method Study Group (Total n=25): A split-mouth study design was planned for the same patient. The right or left upper and lower jaws of the patients will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth tooth surface cleaning and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the periodontal dressings are in place. Patients' wound dressings will be removed after 1 week.
Patients who applied to the Department of Periodontology, Gülhane Dental School, Health Sciences University, and were diagnosed with periodontitis (Stage 3-Grade A) during the clinical examination and underwent routine non-surgical periodontal treatment will be included in the study if they voluntarily agree to participate. Patients who have used antibiotics in the last 3 months, patients who have undergone periodontal treatment in the last 6 months, patients with systemic diseases, patients who smoke, patients with pain, patients with interproximal caries, patients using orthodontic appliances and/or removable prostheses, and patients who are pregnant or breastfeeding will not be included in the study. Participants will be advised not to use any medications during the study period.
At baseline and at 1 and 3 months after treatment, patients' Gingival Indices⁶ (GI/ Loe and Silness Gingival index), Plaque Indices⁷ (PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index), and Papillary Bleeding Indices⁸ (PBI/ Saxer et al.) and Bleeding on Probing Indexes9 (BOP), Probing Pocket Depth10 (SCD), and Clinical Attachment Loss11 (CAL) will be recorded. At the start of treatment and 1 month after treatment, plaque samples will be collected from the deepest pockets on the right and left sides, and the total bacterial load will be compared.
Clinical follow-ups to be performed by the physician
Clinical Records:
The patient's age, gender, and systemic diseases will be recorded. Upon the patient's first visit, all oral clinical indices will be taken, and plaque samples will be collected from the deepest pathological pockets.
The form used for diagnosis for every patient who comes to our clinic is provided in the attachment. The indices to be checked during the examination are listed below.
Gingival Index (GI, Löe \& Silness, 1963, 1967) This index was developed by Löe and Silness in 1963 and modified by various researchers in 1967. In this system, bleeding, the most fundamental sign of inflammation, is evaluated. The mesial, distal, vestibular, and lingual gingivae of the teeth are evaluated. These values are then added together and divided by four. This is how the gingival index is calculated. Dividing the sum of the values by the number of teeth gives the individual's score.
Gingival Index Values
- 0 Healthy gums, no inflammation.
- 1 Mild inflammation, discoloration, and slight edema in the gums, no bleeding on probing.
- 2 Moderate inflammation, redness, and edema in the gums, bleeding on probing.
- 3 Severe inflammation, redness, and edema in the gums, spontaneous bleeding is observed.
Papilla Bleeding Index (PBI, Saxer \& Mühleman, 1975) Bleeding in the gingival papilla is assessed by probing. Probing is performed on 4 half-jaws. However, to ensure that the assessment reflects the inflammation of all papillae and to facilitate the procedure, the assessment is performed on the papillae on the facial surfaces of the teeth in the right upper and left lower jaws on the oral side, and in the left upper and right lower jaws on the buccal side. The values found are then divided by the total number of papillae to find the average papillary bleeding index value. This index is very important in terms of patient motivation. Patients who see bleeding in their gums can easily identify the diseased area in their mouth and develop positive behaviors in applying the oral care procedures they have been taught.
Papillary Bleeding Index Values
- 0 No bleeding.
- 1 There is slight bleeding 20 seconds after probing.
- 2 There is linear bleeding in the papilla area after probing.
- 3 There is bleeding that fills the interdental area after probing.
- 4 Excessive bleeding overflowing from the interdental area after probing. Plaque Index(PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index) Investigates the amount of plaque on the facial and lingual surfaces using a plaque-disclosing agent. The total score is divided by the number of surfaces examined, and the index score for the individual is determined.
The plaque-disclosing agent (Tri Plaque ID GelTM, GC Dental, USA) is applied to all tooth surfaces using a fine-tipped brush.
Areas on the tooth surfaces stained pink, purple, or blue are scored from 0 to 5 (Score 0: no plaque, 1: isolated plaque patches at the gingival margin, 2: plaque in a thin band at the gingival margin, 3: plaque covering less than 1/3 of the tooth surface, 4: plaque covering no more than 2/3 of the tooth surface, 5: plaque covering more than 2/3 of the tooth surface). The entire mouth is divided into 6 different areas, and the average TQHPI values of the participants are calculated by taking the mathematical ratio of the values obtained from the mesial, distal, lingual, and vestibular surfaces of specific teeth in each sextant.
Bleeding on Probing Index ( Ainamo \& Bay, 1976) In this index, probing and bleeding are evaluated by gently probing the pocket. The evaluation is based on the presence or absence of bleeding in the gums as a result of probing. If bleeding occurs within 10-15 seconds after probing all teeth in the mesial, distal, vestibular, and lingual gingival sections, a positive value is given. The ratio of the bleeding area to the examined area is expressed as a percentage.
Probable pocket depth Probable pocket depth, or probing depth, is a numerical value obtained by measuring the distance between the gingival margin and the gingival sulcus/pocket base using a standard periodontal probe with a tip diameter of approximately 0.4-0.5 mm and rounding to the nearest mm.16 Clinical Attachment Loss (CAL): This is the value obtained by measuring the distance between the pocket base and the enamel-cementum junction using a standard periodontal probe with a diameter of 0.4-0.5 mm and rounding it to the nearest mm.
Postoperative records Clinical indices will be taken before periodontal treatment, at 1 month, and at 3 months.
Form Appendix -D has been created for clinical follow-ups to be performed by the physician.
Microbiological examination:
Plaque samples taken from each patient for microorganism quantification will be stored in Eppendorf tubes at -80°C with sterile distilled water until microbial analysis.
Plaque samples stored at -80°C in Eppendorf tubes will be transported in dry ice thermal storage bags by personal vehicle to the laboratories of Kırklareli University Faculty of Medicine, where microbiological examination will be performed.
DNA isolation will be performed from all suture samples using High Pure PCR Template (Roche Diagnostics GmBH, Mannheim, Germany) according to the manufacturer's instructions. DNA will be stored at 80°C until the process is completed.
The 16S rRNA gene will be detected by qPCR, and the total amount of bacteria will be determined. The 16S rRNA gene will be amplified using primers specific to the 16S rRNA gene: 50-TCCTACGGGAGCACAGT-30 and 50-GGACTACCAGG GTATCTAATCCTG T-30. To establish a standard curve for quantification, 16S-specific plasmids with known values will be obtained from Bioeksen (Istanbul, Turkey). Real-time PCR procedures will be performed on the LightCycler 480 II system using the Fast Start Essential DNA Green Master Mix Kit (Roche Diagnostics, Mannheim, Germany) according to the manufacturer's instructions. The analysis will be performed in a total volume of 20 mL with 5 mL of template DNA and 15 mL of master mix. The real-time PCR (qPCR) protocol will consist of enzyme activation at 95°C for 10 minutes; 40 PCR cycles (single read) at 95°C for 20 seconds, 60°C for 20 seconds, and 72°C for 15 seconds; and 10 seconds at 95°C, followed by 1 minute at 65°C for melting curve analysis, and continuous reading at 95°C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study Group (Total n=25): A split-mouth study design was planned for the same patient. The right or left upper and lower jaws of the patients will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth tooth surface cleaning and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the periodontal dressings are in place. Patients' wound dressings will be removed after 1 week. Patients who applied to the Department of Periodontology, Gülhane Dental School, Health Sciences University, and were diagnosed with periodontitis (Stage 3-Grade A) during the clinical examination and underwent routine non-surgical periodontal treatment will be included in the study
| Arm | Type | Receives |
|---|---|---|
| Ora-aid side | Experimental | Procedure: Coe-Pack applicationA split-mouth study design has been planned for the same patient. The patient's right or left upper and lower jaws will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth scaling and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the dressings are in place. The wound dressings will be removed after 1 week. |
| Coe-pack side | Experimental | Procedure: Ora Aid applicationA split-mouth study design has been planned for the same patient. The patient's right or left upper and lower jaws will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth scaling and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the dressings are in place. The wound dressings will be removed after 1 week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Systemically healthy volunteers aged 18-45 years.
- Diagnosis of Periodontitis (Stage 3, Grade A).
- Presence of at least 20 permanent teeth.
- Capacity to understand the study protocol and provide informed consent.
Key exclusion criteria (5 listed)
- Systemic diseases (e.g., Diabetes, Chronic Renal Failure, Cancer, Connective Tissue Disorders).
- Pregnancy or breastfeeding.
- Smoking (>10 cigarettes/day).
- Antibiotic use within the last 3 months or periodontal treatment within the last year.
- Presence of orthodontic appliances, removable prostheses, or extensive interproximal caries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ora Aid applicationBaseline: Comprehensive periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) will be recorded. Subgingival plaque samples will be collected from the deepest periodontal pockets for microbiological analysis. Intervention: Following full-mouth scaling and root planing (SRP), Ora-Aid or Coe-Pak dressings will be applied to the designated quadrants. 1-Week Follow-up: Periodontal dressings will be professionally removed from all treated sites. 1-Month Follow-up: Periodontal clinical indices will be re-evaluated. Plaque samples will be collected from the same initial sites to determine changes in total bacterial load via qPCR. 3-Month Follow-up: Final periodontal clinical measurements will be recorded to assess long-term treatment efficacy and clinical attachment gains. | Procedure or surgery | Coe-pack side |
| Coe-Pack applicationBaseline: Comprehensive periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) will be recorded. Subgingival plaque samples will be collected from the deepest periodontal pockets for microbiological analysis. Intervention: Following full-mouth scaling and root planing (SRP), Ora-Aid or Coe-Pak dressings will be applied to the designated quadrants. 1-Week Follow-up: Periodontal dressings will be professionally removed from all treated sites. 1-Month Follow-up: Periodontal clinical indices will be re-evaluated. Plaque samples will be collected from the same initial sites to determine changes in total bacterial load via qPCR. 3-Month Follow-up: Final periodontal clinical measurements will be recorded to assess long-term treatment efficacy and clinical attachment gains | Procedure or surgery | Ora-aid side |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: Baseline, 1st and 3rd months
PPD will be measured at six sites per tooth using a calibrated periodontal probe. The mean value per patient will be calculated. A decrease in PPD indicates clinical improvement. Unit of Measure: Millimeters (mm)
total bacterial load
Time frame: baseline, 1 month, and 3 months
This study involves the longitudinal comparison of total bacterial load, assessed via plaque samples collected from the deepest periodontal pockets on both the right and left sides at baseline, 1 month, and 3 months post-treatment.
4 secondary outcomes
Evoluation of Gingival Index (GI)
Time frame: Baseline, 1st and 3rd months.
Plaque Index (PI) Scores
Time frame: Baseline, 1 month, 3 months.
Percentage of Sites with Bleeding on Probing (BOP)
Time frame: Baseline, 1 month, 3 months.
Change in Clinical Attachment Loss (CAL)
Time frame: Baseline, 1 month, 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided. A decision has not yet been made regarding the sharing of individual participant data. The decision will be finalized upon the completion of the study and publication of the primary results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ora Aid application and Coe-Pack application in people with Periodontitis and Periodontitis (Stage 3), run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEVAL CEYLAN ŞEN, Assist Prof (+905333161232, dt.sceylan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) (time frame: Baseline, 1st and 3rd months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.