Gingival Phenotype, Gingival Recession, Hyaluronic Acid, Open Flap Debridement, Periodontitis
Conditions
Keywords
Hyaluronic acid, Periodontitis, Open Flap Debridement, Gingival recession
Brief 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. 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.
Interventions
PROCEDUREProcedure/Surgery: Hyaluronic acid gel application
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.
PROCEDUREgiving an impression of the application
In the control group, instead of HA gel, the area was irrigated with physiological saline solution.
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of periodontitis (Stage II/III); 2. 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; 3. a thin gingival phenotype; 4. Areas with horizontal bone loss without intra-bony defects, where no additional hard and soft tissue augmentation was required 5. a full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS \<20%.
Exclusion criteria
* Systemic diseases * Smokers * Pregnant or lactating women * Those who received periodontal treatment within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level (CAL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of 2D Gingival Thickness Changes | Baseline - 3months - 6 months | 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. |
| Relative gingival recession (rGR) | Baseline - 3months - 6 months | 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). |
| 3D Measurements | Baseline - 3months - 6 months | 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. |
| Plaque (P) | Baseline - 3months - 6 months | 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. |
| Bleeding on probing (BoP) | Baseline - 3months - 6 months | 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. |
| Probing depth (PD) | Baseline - 3months - 6 months | Defined as the distance from the base of the periodontal pocket to the marginal gingiva |
Countries
Turkey (Türkiye)
Outcome results
None listed