Hyaluronic AcidNCT07130266
Adjunctive 0.8% Hyaluronic Acid Gel in Open-Flap Surgery for Thin Gingival Phenotype in Patients With Periodontitis
A study testing Procedure/Surgery: Hyaluronic acid gel application and giving an impression of the application in people with Hyaluronic Acid and Open Flap Debridement, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the clinical effectiveness of 0.8% hyaluronic acid (HA) gel as an adjunct to open flap debridement (OFD) in periodontitis patients with a thin gingival phenotype. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyaluronic Acid, Open Flap Debridement, Periodontitis
- What is being tested?
- Procedure/Surgery: Hyaluronic acid gel application and giving an impression of the application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2022to 22 Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of periodontitis (Stage II/III);
- Presence of horizontal bone loss with at least three adjacent teeth, each exhibiting a probing depth ≥ 5mm and a keratinized tissue width ≥ 2mm on single-rooted teeth;
- a thin gingival phenotype;
- Areas with horizontal bone loss without intra-bony defects, where no additional hard and soft tissue augmentation was required
- a full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS <20%.
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: Evaluation of the Clinical and Volumetric Effectiveness of 0.8% Hyaluronic Acid Gel Adjunct to Open-Flap Surgery in Periodontitis Patients With Thin Gingival Phenotype
The aim of this study is to evaluate the clinical effectiveness of 0.8% hyaluronic acid (HA) gel as an adjunct to open flap debridement (OFD) in periodontitis patients with a thin gingival phenotype.
The primary research question is:
Read more
Does the adjunctive use of 0.8% HA gel reduce gingival recession and improve clinical parameters? To answer this, researchers will compare the adjunctive use of 0.8% HA gel to physiological saline in combination with OFD, assessing their effects on clinical outcomes and gingival recession in patients with a thin gingival phenotype.
Participants will:
- Receive 0.8% HA gel application during OFD surgery and a second application at 4 weeks postoperatively.
- Attend follow-up visits at 1, 3, and 6 months after surgery for clinical assessments and measurements.
Read the detailed description
A total of 40 patients were enrolled in the study and randomly assigned to two groups: (a) OFD + 0.8% HA gel (n = 20, test group) and (b) OFD alone (n = 20, control group). Clinical parameters including plaque (P), bleeding on probing (BoP), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline. Following initial periodontal therapy, sites with PPD ≥ 5 mm and horizontal bone loss, were identified in patients with a thin gingival phenotype, determined using color-coded gingival probes. Intraoral digital scans were taken, and relative gingival recession (rGR) was recorded immediately before surgery.
During OFD, the test group received adjunctive 0.8% HA gel, while the control group received physiological saline. In the test group, HA gel application was repeated at 4 weeks postoperatively. Changes in soft tissue volume (mm³) and thickness (mm) were measured using specialized computer software. Follow-up evaluations were performed at 3 and 6 months post-treatment.
- Conditions
- Hyaluronic Acid, Open Flap Debridement, Periodontitis, Gingival Phenotype, Gingival Recession
- Being tested
- Procedure/Surgery: Hyaluronic acid gel application, giving an impression of the application
- Keywords
- Hyaluronic acid, Periodontitis, Open Flap Debridement, Gingival recession
- Medical subject headings
- Periodontitis, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Surgery: Hyaluronic acid gel applicationProcedure or surgery
After root surface cleaning and infected cement removal, 0.8% HA gel was applied to the root surface, bone, and inner surface of the flap and left for 2 minutes.
giving an impression of the applicationProcedure or surgery
In the control group, instead of HA gel, the area was irrigated with physiological saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Open Flap Debridement (OFD) | Placebo comparator | Open flap debridement was carried out, and the surgical site was irrigated with physiological saline in a manner consistent with the HA gel application protocol in the test group. A second application of physiological saline to the sulcus area was performed four weeks postoperatively Receives: Procedure: giving an impression of the application |
| Open Flap Debridement (OFD)+HA | Active comparator | Open flap debridement was carried out, and 1 ml of 0.8% HA gel was applied to the root surfaces of the affected teeth, bone, and the inner surface of the flap in the surgical area for 2 minutes. HA gel application was repeated at four weeks postoperatively. Receives: Procedure: Procedure/Surgery: Hyaluronic acid gel application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL)
CAL were measured from both the buccal and palatal/lingual aspects of each tooth at six points including mesial, distal, and midpoint, and recorded in mm. CAL was measured as the distance between the base of the pocket and the enamel cement junction.
Measured: Baseline - 3months - 6 months
Secondary outcomes (6)
3D Measurements
The median tooth in the area of three adjacent teeth undergoing surgery was chosen for analysis, as it included the interproximal papilla regions of the adjacent teeth treated with periodontal surgery. Data from the 3rd and 6th months intraoral digital scans were extracted separately from the baseline, and the region for volumetric analysis was divided into three equal parts: mesial, distal, and middle. The interproximal and middle regions were evaluated separately, and the volumetric changes over time were calculated in mm³ using the program.
Measured: Baseline - 3months - 6 months
Analysis of 2D Gingival Thickness Changes
The change in gingival thickness at all time points was calculated using standard reference points on the previously superimposed models. Gingival thickness change was measured in 2D at these points, and repeated for both buccal and palatal/lingual regions.
Measured: Baseline - 3months - 6 months
Relative gingival recession (rGR)
The distance between the horizontal reference point on the acrylic stent and the marginal gingiva at the surgical site was measured and recorded as relative gingival recession (rGR).
Measured: Baseline - 3months - 6 months
Probing depth (PD)
Defined as the distance from the base of the periodontal pocket to the marginal gingiva
Measured: Baseline - 3months - 6 months
Plaque (P)
presence of plaque (P) was evaluated as present/absent at six points of each tooth and recorded as percentages. Surgical site measurements were repeated at 3-and 6 months.
Measured: Baseline - 3months - 6 months
Bleeding on probing (BoP)
Bleeding on probing (BoP) was evaluated as present/absent at six points of each tooth and recorded as percentages. Surgical site measurements were repeated at 3-and 6 months.
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 posted19 Aug 2025
- Study start9 May 2022
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaluronic AcidStudies 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
- During the surgery session, patients were block randomized, with the allocation order using a computer program (www.randomizer.org.). Group assignment was carried out by another investigator who was not involved in the treatment procedure or clinical measurements (UGE). Study groups were as follows: 1. OFD + 0.8% HA gel (n = 20, test group) 2. OFD alone (n = 20, control group).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sadiye Gunpinar, Assoc. Prof., Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130266
- Sponsor's protocol ID
- E.69156
- Other IDs
- 20220801
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Volumetric Effectiveness of 0.8% Hyaluronic Acid Gel Adjunct to Open-Flap Surgery in Periodontitis Patients With Thin Gingival Phenotype
- ClinicalTrials.gov ID
- NCT07130266
- Acronym / sponsor ID
- E.69156
- Conditions
- Hyaluronic Acid, Open Flap Debridement, Periodontitis, Gingival Phenotype, Gingival Recession
- Keywords
- Hyaluronic acid, Periodontitis, Open Flap Debridement, Gingival recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 19 Aug 2025 (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.
The aim of this study is to evaluate the clinical effectiveness of 0.8% hyaluronic acid (HA) gel as an adjunct to open flap debridement (OFD) in periodontitis patients with a thin gingival phenotype.
The primary research question is:
Does the adjunctive use of 0.8% HA gel reduce gingival recession and improve clinical parameters? To answer this, researchers will compare the adjunctive use of 0.8% HA gel to physiological saline in combination with OFD, assessing their effects on clinical outcomes and gingival recession in patients with a thin gingival phenotype.
Participants will:
- Receive 0.8% HA gel application during OFD surgery and a second application at 4 weeks postoperatively.
- Attend follow-up visits at 1, 3, and 6 months after surgery for clinical assessments and measurements.
Detailed description
A total of 40 patients were enrolled in the study and randomly assigned to two groups: (a) OFD + 0.8% HA gel (n = 20, test group) and (b) OFD alone (n = 20, control group). Clinical parameters including plaque (P), bleeding on probing (BoP), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline. Following initial periodontal therapy, sites with PPD ≥ 5 mm and horizontal bone loss, were identified in patients with a thin gingival phenotype, determined using color-coded gingival probes. Intraoral digital scans were taken, and relative gingival recession (rGR) was recorded immediately before surgery.
During OFD, the test group received adjunctive 0.8% HA gel, while the control group received physiological saline. In the test group, HA gel application was repeated at 4 weeks postoperatively. Changes in soft tissue volume (mm³) and thickness (mm) were measured using specialized computer software. Follow-up evaluations were performed at 3 and 6 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- During the surgery session, patients were block randomized, with the allocation order using a computer program (www.randomizer.org.). Group assignment was carried out by another investigator who was not involved in the treatment procedure or clinical measurements (UGE). Study groups were as follows: 1. OFD + 0.8% HA gel (n = 20, test group) 2. OFD alone (n = 20, control group).
| Arm | Type | Receives |
|---|---|---|
| Open Flap Debridement (OFD) | Placebo comparator | Procedure: giving an impression of the applicationOpen flap debridement was carried out, and the surgical site was irrigated with physiological saline in a manner consistent with the HA gel application protocol in the test group. A second application of physiological saline to the sulcus area was performed four weeks postoperatively |
| Open Flap Debridement (OFD)+HA | Active comparator | Procedure: Procedure/Surgery: Hyaluronic acid gel applicationOpen flap debridement was carried out, and 1 ml of 0.8% HA gel was applied to the root surfaces of the affected teeth, bone, and the inner surface of the flap in the surgical area for 2 minutes. HA gel application was repeated at four weeks postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of periodontitis (Stage II/III);
- Presence of horizontal bone loss with at least three adjacent teeth, each exhibiting a probing depth ≥ 5mm and a keratinized tissue width ≥ 2mm on single-rooted teeth;
- a thin gingival phenotype;
- Areas with horizontal bone loss without intra-bony defects, where no additional hard and soft tissue augmentation was required
- a full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS <20%.
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 |
|---|---|---|
| Procedure/Surgery: Hyaluronic acid gel applicationAfter root surface cleaning and infected cement removal, 0.8% HA gel was applied to the root surface, bone, and inner surface of the flap and left for 2 minutes. | Procedure or surgery | Open Flap Debridement (OFD)+HA |
| giving an impression of the applicationIn the control group, instead of HA gel, the area was irrigated with physiological saline solution. | Procedure or surgery | Open Flap Debridement (OFD) |
Primary outcome
Clinical attachment level (CAL)
Time frame: Baseline - 3months - 6 months
CAL were measured from both the buccal and palatal/lingual aspects of each tooth at six points including mesial, distal, and midpoint, and recorded in mm. CAL was measured as the distance between the base of the pocket and the enamel cement junction.
6 secondary outcomes
3D Measurements
Time frame: Baseline - 3months - 6 months
Analysis of 2D Gingival Thickness Changes
Time frame: Baseline - 3months - 6 months
Relative gingival recession (rGR)
Time frame: Baseline - 3months - 6 months
Probing depth (PD)
Time frame: Baseline - 3months - 6 months
Plaque (P)
Time frame: Baseline - 3months - 6 months
Bleeding on probing (BoP)
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 27 Aug 2025.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan.
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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, Assoc. Prof. principal investigator
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 Procedure/Surgery: Hyaluronic acid gel application and giving an impression of the application in people with Hyaluronic Acid and Open Flap Debridement, 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 5 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 27 Aug 2025. 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?
Clinical attachment level (CAL) (time frame: Baseline - 3months - 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 27 Aug 2025.