PeriodontitisNCT06214728
Use of Hyaluronic Acid Gel in Intraosseous Defects
A study testing Hyaluronic acid gel application in people with Periodontitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this randomised, parallel-arm, blinded, controlled clinical trial was to compare the clinical and radiographic efficacy of MINST with and without 0.8% HA gel application in the treatment of intraosseous defects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Hyaluronic acid gel application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2022to 12 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of severe/progressed periodontitis (stage III/IV)
- Presence of an intraosseous defect with a probing depth ≥ 5 mm and defect depth ≥ 3 mm;
- Absence of furcation involvement,mobility and subgingival restoration in the vital tooth with intraosseous defect.
Who cannot join
- Systemic diseases
- Smokers
- Pregnant or lactating women
- Those who received periodontal treatment within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assesment of Changes ın Clinical and Radiographic Parameters Following the Application of Local Hyaluronic acıd Gel as an Adjunct to Minimally Invasive Non-surgical Treatment of Intraosseous Defects
Aim:
The aim of this randomised, parallel-arm, blinded, controlled clinical trial was to compare the clinical and radiographic efficacy of MINST with and without 0.8% HA gel application in the treatment of intraosseous defects.
Research Hypothesis:
The null hypothesis that there is no statistically significant difference in clinical and radiographic measurements between the use of HA gel in addition to MINST for the treatment of intraosseous defects and MINST treatment alone was tested.
Read the detailed description
This study was designed as a randomised controlled clinical trial and conducted between March 2022 and May 2023 at the Department of Periodontology, Bezmialem Vakıf University. Ethical approval was obtained from Clinical Research Ethics Committee of Bezmialem Vakıf University with approval number E.54753 on March 15, 2022.
The patients included in our study were selected from a total of 140 patients with complaints of gingival problems who applied to the Department of Periodontology at Bezmialem Vakıf University Faculty of Dentistry, specifically those having intraosseous defects in the premolar/molar teeth. Forty-two individuals were included in the study, and it was completed with a total of 36 participants, consisting of 25 females and 11 males.
Initial clinical periodontal measurements and periapical radiographs were taken from the defect area with parallel technique in the first session. Occlusal stents with fixed guide points were prepared to place the periodontal probe with the correct angle and inclination. During the initial session, complete oral supragingival calculus cleaning and oral hygiene motivation were performed. After that, patients were randomly assigned to the test (MINST + HA, n = 17) or control (MINST, n = 19) groups. Neither the patients nor the expert responsible for the clinical measurements (UGE) was aware of which treatment each individual had received.
The MINST concepts described by Nibali et al. were followed in the treatment protocol. During the procedure, a subpapillary approach was taken to reduce trauma to the soft tissues, particularly the papillae, using a 2.5x420 mm magnification loop . The instruments were gently placed within the periodontal pocket while the patient was under local anaesthesia , in order to keep the soft tissues stable. Using mini five curettes and ultrasonic devices with precise tips ,the root surfaces were cleaned reaching to the base of the pocket, avoiding excessive root surface smoothing and gingival curettage. The subgingival area was not irrigated to prevent deterioration of clot stabilisation during the wound healing process [1]. MINST was performed in all areas of the oral cavity with periodontal pockets >3 mm. The control group was treated with MINST alone without using any irrigation solution. Beside, in the test group, following MINST protocol same as in the control, HA gel was applied to the periodontal pockets where the intraosseous defect was located using a sterile injector with a plastic needle. The gel was applied until it overflowed from the gingival sulcus. Patients were instructed not to eat, drink or brush their teeth for at least one hour. Subgingival application of HA was repeated 4 weeks after the first session. The control group received placebo HA gel probe without rinsing.
Clinical examination Initial clinical measurements were taken by a single investigator (UGE) using the UNC15 probe at six sites on all teeth to determine the stage and grade of periodontitis in study population.
Clinical periodontal measurements of the defect site were recorded at baseline and repeated at 3 and 6 months following treatment. Probing depth (PD), clinical attachment level (CAL) and gingival recession (GR) measurements were made from two points including buccal and lingual area through a patient-specific acrylic stent in the defect area and recorded as average and deepest/worst. Bleeding on probing (BoP) and presence of plaque (P) were evaluated as present/absent in the buccal and lingual part of the defect area and recorded as %.
The gingival phenotype was evaluated by observing the probe's silhouette visibility using biotype probe located in the buccal point of the intraosseous defect area.
Pre-study investigator calibration was performed by repeating the PD and CAL measurements of 10 periodontitis patients who were not included in the study at 24 hours intervals. The intraclass correlation showed that the researcher's repeatability was at an acceptable level (PD; k-score: 0,817-0,952; CAL:0,836-0,926).
Radiographic examination For the diagnosis of intraosseous defects radiographs were taken at baseline and 6-month follow-up using a custom-made radiographic stent and the parallel cone technique. Radiographs were digitized and analysed by a single calibrated investigator using a computer software (Planmeca Romexis Viewer software). The radiographs were numbered prior to analysis to blind the analyst to the groups of radiographs. For investigator calibration, measurements of intraosseous defect depth (infra) and defect angle of periapical radiographs from 10 nonstudy patients were repeated at 24-hour intervals. Intra-class correlation coefficients ranging from 0.86 to 0.92 for the defect depth and angle measurements and it was determined that the reproducibility of the researcher was at an acceptable level. Radiographic measurements were made by using the reference points on tooth surface. Total defect depth (TDD): The distance from the cemento- enamel junction to the base of the defect (CEJ-DD) was measured. Intraosseous defect depth (INFRA): It is the distance from the projection of the alveolar crest point on the tooth to the bottom of the defect (DD). Distance from the CEJ to the alveolar crest (CEJ-BC): It is the distance from the projection of the alveolar crest point on the tooth and the cemento enamel junction (CEJ). Intra-osseous defect angle: The radiographic defect angle was measured between the CEJ-BD line of the involved tooth and the bone defect surface.
- Conditions
- Periodontitis
- Being tested
- Hyaluronic acid gel application, Placebo gel application
- Keywords
- minimally invasive, nonsurgical periodontal debridements, periodontitis, alveolar bone loss, hyaluronic acid
- Medical subject headings
- Periodontitis, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid gel applicationProcedure or surgery
HA gel was applied to the periodontal pockets where the intraosseous defect was located using a sterile injector with a plastic needle. The gel was applied until it overflowed from the gingival sulcus. Patients were instructed not to eat, drink or brush their teeth for at least one hour. Subgingival application of HA was repeated 4 weeks after the first session.
Placebo gel applicationProcedure or surgery
The control group received placebo HA gel probe without rinsing. Placebo application was repeated 4 weeks after the first session.
| Study group | Role | What they receive |
|---|---|---|
| MINST | Placebo comparator | Minimally invasive non-surgical treatment (MINST): Using mini five curettes and ultrasonic devices with precise tips , the root surfaces were cleaned reaching to the base of the pocket, avoiding excessive root surface smoothing and gingival curettage. Receives: Procedure: Placebo gel application |
| MINST+HA | Active comparator | Minimally invasive non-surgical technique (MINST) with application of Hyaluronıc Acid gel: Using mini five curettes and ultrasonic devices with precise tips , the root surfaces were cleaned reaching to the base of the pocket, avoiding excessive root surface smoothing and gingival curettage. HA gel was applied to the periodontal pockets where the intraosseous defect was located using a sterile injector with a plastic needle. The gel was applied until it overflowed from the gingival sulcus. Receives: Procedure: Hyaluronic acid gel application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraosseous defect depth (INFRA)
It is the distance from the projection of the alveolar crest point on the tooth to the bottom of the defect (DD)
Measured: Baseline - 6 months
Secondary outcomes (2)
Probing depth (PD)
as the measurement of the length between the bottom of the periodontal pocket to marginal gingiva
Measured: Baseline - 3months - 6 months
Clinical attachment level (CAL)
distance between the base of the pocket and the enamel cement junction
Measured: Baseline - 3months - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start16 Mar 2022
- Primary completion12 May 2023
- Study completion12 May 2023
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 Bezmialem Vakif UniversityThe 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
- Subjects having more than one intrabony defect that meets the inclusion criteria, only one intraosseous defect per patient was included based on a preliminary randomisation by a coin toss (UGE). Patients were then block randomised and the allocation sequence was computer-generated using www.randomizer.org. The patient groups were recorded by another investigator who did not perform the treatment application and clinical measurements (SG).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sadiye Gunpinar, Asc. Prof., Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214728
- Sponsor's protocol ID
- UGUNDOGDU1
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- 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 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Changes ın Clinical and Radiographic Parameters Following the Application of Local Hyaluronic acıd Gel as an Adjunct to Minimally Invasive Non-surgical Treatment of Intraosseous Defects
- ClinicalTrials.gov ID
- NCT06214728
- Acronym / sponsor ID
- UGUNDOGDU1
- Conditions
- Periodontitis
- Keywords
- minimally invasive, nonsurgical periodontal debridements, periodontitis, alveolar bone loss, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 22 Jan 2024 (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.
Aim:
The aim of this randomised, parallel-arm, blinded, controlled clinical trial was to compare the clinical and radiographic efficacy of MINST with and without 0.8% HA gel application in the treatment of intraosseous defects.
Research Hypothesis:
The null hypothesis that there is no statistically significant difference in clinical and radiographic measurements between the use of HA gel in addition to MINST for the treatment of intraosseous defects and MINST treatment alone was tested.
Detailed description
This study was designed as a randomised controlled clinical trial and conducted between March 2022 and May 2023 at the Department of Periodontology, Bezmialem Vakıf University. Ethical approval was obtained from Clinical Research Ethics Committee of Bezmialem Vakıf University with approval number E.54753 on March 15, 2022.
The patients included in our study were selected from a total of 140 patients with complaints of gingival problems who applied to the Department of Periodontology at Bezmialem Vakıf University Faculty of Dentistry, specifically those having intraosseous defects in the premolar/molar teeth. Forty-two individuals were included in the study, and it was completed with a total of 36 participants, consisting of 25 females and 11 males.
Initial clinical periodontal measurements and periapical radiographs were taken from the defect area with parallel technique in the first session. Occlusal stents with fixed guide points were prepared to place the periodontal probe with the correct angle and inclination. During the initial session, complete oral supragingival calculus cleaning and oral hygiene motivation were performed. After that, patients were randomly assigned to the test (MINST + HA, n = 17) or control (MINST, n = 19) groups. Neither the patients nor the expert responsible for the clinical measurements (UGE) was aware of which treatment each individual had received.
The MINST concepts described by Nibali et al. were followed in the treatment protocol. During the procedure, a subpapillary approach was taken to reduce trauma to the soft tissues, particularly the papillae, using a 2.5x420 mm magnification loop . The instruments were gently placed within the periodontal pocket while the patient was under local anaesthesia , in order to keep the soft tissues stable. Using mini five curettes and ultrasonic devices with precise tips ,the root surfaces were cleaned reaching to the base of the pocket, avoiding excessive root surface smoothing and gingival curettage. The subgingival area was not irrigated to prevent deterioration of clot stabilisation during the wound healing process [1]. MINST was performed in all areas of the oral cavity with periodontal pockets >3 mm. The control group was treated with MINST alone without using any irrigation solution. Beside, in the test group, following MINST protocol same as in the control, HA gel was applied to the periodontal pockets where the intraosseous defect was located using a sterile injector with a plastic needle. The gel was applied until it overflowed from the gingival sulcus. Patients were instructed not to eat, drink or brush their teeth for at least one hour. Subgingival application of HA was repeated 4 weeks after the first session. The control group received placebo HA gel probe without rinsing.
Clinical examination Initial clinical measurements were taken by a single investigator (UGE) using the UNC15 probe at six sites on all teeth to determine the stage and grade of periodontitis in study population.
Clinical periodontal measurements of the defect site were recorded at baseline and repeated at 3 and 6 months following treatment. Probing depth (PD), clinical attachment level (CAL) and gingival recession (GR) measurements were made from two points including buccal and lingual area through a patient-specific acrylic stent in the defect area and recorded as average and deepest/worst. Bleeding on probing (BoP) and presence of plaque (P) were evaluated as present/absent in the buccal and lingual part of the defect area and recorded as %.
The gingival phenotype was evaluated by observing the probe's silhouette visibility using biotype probe located in the buccal point of the intraosseous defect area.
Pre-study investigator calibration was performed by repeating the PD and CAL measurements of 10 periodontitis patients who were not included in the study at 24 hours intervals. The intraclass correlation showed that the researcher's repeatability was at an acceptable level (PD; k-score: 0,817-0,952; CAL:0,836-0,926).
Radiographic examination For the diagnosis of intraosseous defects radiographs were taken at baseline and 6-month follow-up using a custom-made radiographic stent and the parallel cone technique. Radiographs were digitized and analysed by a single calibrated investigator using a computer software (Planmeca Romexis Viewer software). The radiographs were numbered prior to analysis to blind the analyst to the groups of radiographs. For investigator calibration, measurements of intraosseous defect depth (infra) and defect angle of periapical radiographs from 10 nonstudy patients were repeated at 24-hour intervals. Intra-class correlation coefficients ranging from 0.86 to 0.92 for the defect depth and angle measurements and it was determined that the reproducibility of the researcher was at an acceptable level. Radiographic measurements were made by using the reference points on tooth surface. Total defect depth (TDD): The distance from the cemento- enamel junction to the base of the defect (CEJ-DD) was measured. Intraosseous defect depth (INFRA): It is the distance from the projection of the alveolar crest point on the tooth to the bottom of the defect (DD). Distance from the CEJ to the alveolar crest (CEJ-BC): It is the distance from the projection of the alveolar crest point on the tooth and the cemento enamel junction (CEJ). Intra-osseous defect angle: The radiographic defect angle was measured between the CEJ-BD line of the involved tooth and the bone defect surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects having more than one intrabony defect that meets the inclusion criteria, only one intraosseous defect per patient was included based on a preliminary randomisation by a coin toss (UGE). Patients were then block randomised and the allocation sequence was computer-generated using www.randomizer.org. The patient groups were recorded by another investigator who did not perform the treatment application and clinical measurements (SG).
| Arm | Type | Receives |
|---|---|---|
| MINST | Placebo comparator | Procedure: Placebo gel applicationMinimally invasive non-surgical treatment (MINST): Using mini five curettes and ultrasonic devices with precise tips , the root surfaces were cleaned reaching to the base of the pocket, avoiding excessive root surface smoothing and gingival curettage. |
| MINST+HA | Active comparator | Procedure: Hyaluronic acid gel applicationMinimally invasive non-surgical technique (MINST) with application of Hyaluronıc Acid gel: Using mini five curettes and ultrasonic devices with precise tips , the root surfaces were cleaned reaching to the base of the pocket, avoiding excessive root surface smoothing and gingival curettage. HA gel was applied to the periodontal pockets where the intraosseous defect was located using a sterile injector with a plastic needle. The gel was applied until it overflowed from the gingival sulcus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of severe/progressed periodontitis (stage III/IV)
- Presence of an intraosseous defect with a probing depth ≥ 5 mm and defect depth ≥ 3 mm;
- Absence of furcation involvement,mobility and subgingival restoration in the vital tooth with intraosseous defect.
Key exclusion criteria (4 listed)
- Systemic diseases
- Smokers
- Pregnant or lactating women
- Those who received periodontal treatment within the last 6 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 |
|---|---|---|
| Hyaluronic acid gel applicationHA gel was applied to the periodontal pockets where the intraosseous defect was located using a sterile injector with a plastic needle. The gel was applied until it overflowed from the gingival sulcus. Patients were instructed not to eat, drink or brush their teeth for at least one hour. Subgingival application of HA was repeated 4 weeks after the first session. | Procedure or surgery | MINST+HA |
| Placebo gel applicationThe control group received placebo HA gel probe without rinsing. Placebo application was repeated 4 weeks after the first session. | Procedure or surgery | MINST |
Primary outcome
Intraosseous defect depth (INFRA)
Time frame: Baseline - 6 months
It is the distance from the projection of the alveolar crest point on the tooth to the bottom of the defect (DD)
2 secondary outcomes
Probing depth (PD)
Time frame: Baseline - 3months - 6 months
Clinical attachment level (CAL)
Time frame: Baseline - 3months - 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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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. This study is not recruiting at the moment.
Sadiye Gunpinar, Asc. Prof. study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid gel application in people with Periodontitis, run by Bezmialem Vakif University at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraosseous defect depth (INFRA) (time frame: Baseline - 6 months). 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 22 Jan 2024.