PeriodontitisNCT07822269
Dental Loupe Versus Dental Operating Microscope for Non-Surgical Periodontal Treatment
A study testing Mechanical debridement and dental plaque sample collection with dental loupe and Mechanical debridement and dental plaque sample collection with dental microscope in people with Periodontitis and Periodontitis and Treatment Need, run by Saglik Bilimleri Universitesi at 3 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontitis and Treatment Need, Periodontal Disease
- What is being tested?
- Mechanical debridement and dental plaque sample collection with dental loupe and Mechanical debridement and dental plaque sample collection with dental microscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 Nov 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years of age
- Being systemically healthy
- Having at least 20 permanent teeth in both upper and lower jaws
- Having periodontitis
- Having the mental capacity to understand the research objectives and methods to be applied as explained in writing and orally
- Being convinced that the volunteer will be suitable and cooperative with the physician-patient before, during and after the procedure
- Not having any physical or psychological condition that would prevent mechanical debridement
- Not being a bacterial or viral carrier
Who cannot join
- Patients under 18 years of age
- Patients who are periodontally healthy
- Smoking more than 10 cigarettes a day
- Having received periodontal treatment within the last year
- Having used antibiotics within the last 3 months
- Being pregnant or breastfeeding
- Those with diabetes, chronic kidney failure, cancer, bleeding disorders, connective tissue diseases, and similar chronic diseases
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites, 3 recruiting
- Not yet recruiting
Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
Ankara
Seval Ceylan Şen, Assistant Professor, +905333161232, dt.sceylan@hotmail.com
Özlem Saraç Atagün, Assistant Professor, +905055096482, ozlemsarac2806@hotmail.com
- Recruiting
Sağlık Bilimleri Üniversitesi Hamidiye Diş Hekimliği Fakültesi
Istanbul, Üsküdar
Tuğçe Paksoy, Associate Professor, +905534490452, tugceakap86@hotmai.com
Alima Budakçı, PHd candidate, +905319841597, alima-97@hotmail.com
- Not yet recruiting
Kırklareli Üniversitesi Tıp Fakültesi Tıbbi Mikrobiyoloji Anabilim Dalı
Kırklareli
Mehmet Demirci, Professor, 05337106295, demircimehmet@hotmail.com
About this study
Official title: Comparison of the Effectiveness of Dental Loupe and Dental Operating Microscope in Non-Surgical Periodontal Treatment
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. Calculus removal, root planing, and mechanical removal of plaque should be considered a fundamental part of initial periodontal treatment. Furthermore, patients who undergo calculus removal and root planing followed by regular maintenance programs experience less tooth loss and clinical attachment loss. Calculus removal and root planing are integral parts of non-surgical periodontal treatment to remove bacterial plaque and calculus from diseased root surfaces. The use of magnification systems to increase the field of view in both surgical and non-surgical procedures dates back to the 1860s with the first use of surgical microscopes. Magnification systems were first used in dentistry in the first half of the 20th century. In 1978, Apotheker and Jako developed the first surgical microscope for use in dentistry. The use of magnifying loupes as visual aids by dentists has become increasingly popular over the years, with continuous improvements in design and effectiveness. A 2019 survey among dentists indicated that magnifying lenses are one of the significant technological advancements in this profession. Periodontal endoscopy is also one of the approaches clinicians use to improve visibility. Dental magnification systems are known to increase effectiveness, especially in interproximal areas where access and visibility are limited. Clinical studies have compared root surface planing procedures performed with periodontal endoscopy with traditional root surface planing. The results of the studies showed a significant difference in clinical outcomes in patients treated with periodontal endoscopy compared to those treated with traditional methods. The aim of this study is to analyze the clinical and microbiological benefits of image magnification systems (dental loupe and dental microscope) in scaling and root surface planing in the treatment of patients with periodontitis.
- Conditions
- Periodontitis, Periodontitis and Treatment Need, Periodontal Disease, Periodontal Pocket, Periodontitis (Stage 3)
- Being tested
- Mechanical debridement and dental plaque sample collection with dental loupe, Mechanical debridement and dental plaque sample collection with dental microscope
- Medical subject headings
- Periodontitis, Periodontal Diseases, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical debridement and dental plaque sample collection with dental loupeDevice
After clinical measurements are taken from Stage 3 Grade A periodontitis patients presenting to the periodontology clinic, a coin toss determines which area will undergo mechanical debridement under dental loupe magnification and which area under dental microscope magnification. Before starting the procedure, a plaque sample will be collected from the deepest pathological pockets in the relevant area for later microbiological examination. Following supragingival and subgingival debridement under local anesthesia using Gracey curettes and an ultrasonic scaler, patients will be placed in a follow-up period.
Mechanical debridement and dental plaque sample collection with dental microscopeDevice
After clinical measurements are taken from Stage 3 Grade A periodontitis patients presenting to the periodontology clinic, a coin toss determines which area will undergo mechanical debridement under dental loupe magnification and which area under dental microscope magnification. Before starting the procedure, a plaque sample will be collected from the deepest pathological pockets in the relevant area for later microbiological examination. Following supragingival and subgingival debridement under local anesthesia using Gracey curettes and an ultrasonic scaler, patients will be placed in a follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Dental Loupe | Experimental | A split-mouth study design was planned for the same patient. The patient's right or left upper or lower jaw would be treated with a dental loupe which determined by a coin toss. Patients diagnosed with periodontitis (Stage 3-Grade A) in the periodontology clinic and undergoing routine non-surgical periodontal treatment would be included in the study if they voluntarily agreed to participate. Receives: Device: Mechanical debridement and dental plaque sample collection with dental loupe |
| Dental Microscope | Experimental | A split-mouth study design was planned for the same patient. The patient's right or left upper or lower jaw would be treated with a dental microscope which determined by a coin toss. Patients diagnosed with periodontitis (Stage 3-Grade A) in the periodontology clinic and undergoing routine non-surgical periodontal treatment would be included in the study if they voluntarily agreed to participate. Receives: Device: Mechanical debridement and dental plaque sample collection with dental microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total microbial load
To determine the amount of microorganisms, plaque samples taken from each patient will be stored in Eppendorf tubes at -80°C with sterile distilled water until microbial analysis is performed.
Plaque samples stored at -80°C in Eppendorf tubes will be transported to the laboratories where microbiological examination will be performed using personal vehicles in dry ice thermal storage bags.
DNA isolation from all suture samples will be performed using the High Pure PCR Template according to the manufacturer's instructions. The DNA will be stored at 80°C until the process is complete. The 16S rRNA gene will be detected by qPCR and the total bacterial count will be determined. Real-time PCR procedures will be performed on a LightCycler 480 II system using the Fast Start Essential DNA Green Master Mix Kit according to the manufacturer's instructions.
Measured: At enrollment. and 1 month control visit
Probing Pocket Depth
Probing pocket depth, or probing depth, is a numerical value obtained by measuring the distance between the gingival margin and the gingival sulcus/pocket floor using a standard periodontal probe with a tip approximately 0.4-0.5 mm in diameter, and rounding the measurement to the nearest millimeter.
Measured: At enrollment, 1 and 3 months control visits
Secondary outcomes (5)
Gingival Index
This index was developed by Löe and Silness in 1963 and modified by various researchers in 1967. The system evaluates bleeding, the most fundamental sign of inflammation. The mesial, distal, vestibular, and lingual gingiva of the teeth are assessed. These values are then summed and divided by four to calculate the gingival index. Dividing the sum of these values by the number of teeth yields the individual score.
0 Healthy gingiva, no inflammation.
- Mild inflammation, discoloration, and slight swelling in the gingiva; no bleeding on probing.
- Moderate inflammation, redness, and swelling in the gingiva; bleeding on probing.
- Severe inflammation, redness, and swelling in the gingiva; spontaneous bleeding occurs.
Measured: At enrollment, 1 and 3 months control visits
Papillary Bleeding Index
Probing is used to evaluate bleeding in the gingival papillae. Probing is performed on all four half-jaws. However, to ensure the evaluation reflects inflammation of all papillae and to facilitate the procedure, evaluation is performed on the papillae on the oral surfaces of the upper right and lower left jaws, and on the facial surfaces of the teeth in the upper left and lower right jaws. The values obtained are then divided by the total number of papillae to find the average papillary bleeding index value. This index is quite important for 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.
- Slight bleeding 20 seconds after probing.
- Linear bleeding in the papillary area after probing.
- Bleeding filling the interdental space after probing.
- Excessive bleeding overflowing from
Measured: At enrollment, 1 and 3 months control visits
Plaque Index (PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index)
The amount of plaque on facial and lingual surfaces is investigated using a plaque-staining agent. The total score is divided by the number of surfaces examined, and an index score is determined for the individual.
The plaque-staining agent (Tri Plaque ID Gel™, GC Dental, USA) is applied to all tooth surfaces using a fine-tipped brush.
Areas stained pink, purple, or blue on the tooth surfaces are scored from 0 to 5 (Score 0: no plaque, 1: independent plaque islands at the gingival margins, 2: thin bands of plaque at the gingival margins, 3: plaque covering no more 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 the specific teeth in each sextant.
Measured: At enrollment, 1 and 3 months control visits
Gingival Bleeding Index (Ainamo & Bay)
This index assesses bleeding by gently probing within the gingival pocket. The presence or absence of bleeding in the gingiva is evaluated based on the probing results. A positive result is given if bleeding occurs within 10-15 seconds after probing the mesial, distal, vestibular, and lingual gingival areas of all teeth. The ratio of the bleeding area to the examined area is expressed as a percentage.
Measured: At enrollment, 1 and 3 month control visits
Clinical attachment loss
This value is 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 the measurement to the nearest millimeter value.
Measured: At enrollment, 1 and 3 months control visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Nov 2027 (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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Paksoy, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822269
- Sponsor's protocol ID
- 25-25
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Dental Loupe and Dental Operating Microscope in Non-Surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT07822269
- Acronym / sponsor ID
- 25-25
- Conditions
- Periodontitis, Periodontitis and Treatment Need, Periodontal Disease, Periodontal Pocket, Periodontitis (Stage 3)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 16 Sep 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.
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. Calculus removal, root planing, and mechanical removal of plaque should be considered a fundamental part of initial periodontal treatment. Furthermore, patients who undergo calculus removal and root planing followed by regular maintenance programs experience less tooth loss and clinical attachment loss. Calculus removal and root planing are integral parts of non-surgical periodontal treatment to remove bacterial plaque and calculus from diseased root surfaces. The use of magnification systems to increase the field of view in both surgical and non-surgical procedures dates back to the 1860s with the first use of surgical microscopes. Magnification systems were first used in dentistry in the first half of the 20th century. In 1978, Apotheker and Jako developed the first surgical microscope for use in dentistry. The use of magnifying loupes as visual aids by dentists has become increasingly popular over the years, with continuous improvements in design and effectiveness. A 2019 survey among dentists indicated that magnifying lenses are one of the significant technological advancements in this profession. Periodontal endoscopy is also one of the approaches clinicians use to improve visibility. Dental magnification systems are known to increase effectiveness, especially in interproximal areas where access and visibility are limited. Clinical studies have compared root surface planing procedures performed with periodontal endoscopy with traditional root surface planing. The results of the studies showed a significant difference in clinical outcomes in patients treated with periodontal endoscopy compared to those treated with traditional methods. The aim of this study is to analyze the clinical and microbiological benefits of image magnification systems (dental loupe and dental microscope) in scaling and root surface planing in the treatment of patients with periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental Loupe | Experimental | Device: Mechanical debridement and dental plaque sample collection with dental loupeA split-mouth study design was planned for the same patient. The patient's right or left upper or lower jaw would be treated with a dental loupe which determined by a coin toss. Patients diagnosed with periodontitis (Stage 3-Grade A) in the periodontology clinic and undergoing routine non-surgical periodontal treatment would be included in the study if they voluntarily agreed to participate. |
| Dental Microscope | Experimental | Device: Mechanical debridement and dental plaque sample collection with dental microscopeA split-mouth study design was planned for the same patient. The patient's right or left upper or lower jaw would be treated with a dental microscope which determined by a coin toss. Patients diagnosed with periodontitis (Stage 3-Grade A) in the periodontology clinic and undergoing routine non-surgical periodontal treatment would be included in the study if they voluntarily agreed to participate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being over 18 years of age
- Being systemically healthy
- Having at least 20 permanent teeth in both upper and lower jaws
- Having periodontitis
- Having the mental capacity to understand the research objectives and methods to be applied as explained in writing and orally
Key exclusion criteria (7 listed)
- Patients under 18 years of age
- Patients who are periodontally healthy
- Smoking more than 10 cigarettes a day
- Having received periodontal treatment within the last year
- Having used antibiotics within the last 3 months
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 |
|---|---|---|
| Mechanical debridement and dental plaque sample collection with dental loupeAfter clinical measurements are taken from Stage 3 Grade A periodontitis patients presenting to the periodontology clinic, a coin toss determines which area will undergo mechanical debridement under dental loupe magnification and which area under dental microscope magnification. Before starting the procedure, a plaque sample will be collected from the deepest pathological pockets in the relevant area for later microbiological examination. Following supragingival and subgingival debridement under local anesthesia using Gracey curettes and an ultrasonic scaler, patients will be placed in a follow-up period. | Device | Dental Loupe |
| Mechanical debridement and dental plaque sample collection with dental microscopeAfter clinical measurements are taken from Stage 3 Grade A periodontitis patients presenting to the periodontology clinic, a coin toss determines which area will undergo mechanical debridement under dental loupe magnification and which area under dental microscope magnification. Before starting the procedure, a plaque sample will be collected from the deepest pathological pockets in the relevant area for later microbiological examination. Following supragingival and subgingival debridement under local anesthesia using Gracey curettes and an ultrasonic scaler, patients will be placed in a follow-up period. | Device | Dental Microscope |
Primary outcome
Total microbial load
Time frame: At enrollment. and 1 month control visit
To determine the amount of microorganisms, plaque samples taken from each patient will be stored in Eppendorf tubes at -80°C with sterile distilled water until microbial analysis is performed. Plaque samples stored at -80°C in Eppendorf tubes will be transported to the laboratories where microbiological examination will be performed using personal vehicles in dry ice thermal storage bags. DNA isolation from all suture samples will be performed using the High Pure PCR Template according to the manufacturer's instructions. The DNA will be stored at 80°C until the process is complete. The 16S rRNA gene will be detected by qPCR and the total bacterial count will be determined. Real-time PCR procedures will be performed on a LightCycler 480 II system using the Fast Start Essential DNA Green Master Mix Kit according to the manufacturer's instructions.
Probing Pocket Depth
Time frame: At enrollment, 1 and 3 months control visits
Probing pocket depth, or probing depth, is a numerical value obtained by measuring the distance between the gingival margin and the gingival sulcus/pocket floor using a standard periodontal probe with a tip approximately 0.4-0.5 mm in diameter, and rounding the measurement to the nearest millimeter.
5 secondary outcomes
Gingival Index
Time frame: At enrollment, 1 and 3 months control visits
Papillary Bleeding Index
Time frame: At enrollment, 1 and 3 months control visits
Plaque Index (PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index)
Time frame: At enrollment, 1 and 3 months control visits
Gingival Bleeding Index (Ainamo & Bay)
Time frame: At enrollment, 1 and 3 month control visits
Clinical attachment loss
Time frame: At enrollment, 1 and 3 months control visits
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 21 Sep 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical debridement and dental plaque sample collection with dental loupe and Mechanical debridement and dental plaque sample collection with dental microscope in people with Periodontitis and Periodontitis and Treatment Need, run by Saglik Bilimleri Universitesi at 3 sites in Turkey (Türkiye).
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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Tuğçe Paksoy, Associate Professor (+905534490452, tugceakap86@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total microbial load (time frame: At enrollment. and 1 month control visit). 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 21 Sep 2026.