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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Clinical attachment level (CAL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •Systemic diseases
- •Pregnant or lactating women
- •Those who received periodontal treatment within the last 6 months
研究组 & 干预措施
Open Flap Debridement (OFD)
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
干预措施: giving an impression of the application (Procedure)
Open Flap Debridement (OFD)+HA
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.
干预措施: Procedure/Surgery: Hyaluronic acid gel application (Procedure)
结局指标
主要结局
Clinical attachment level (CAL)
时间窗: 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.
次要结局
- Probing depth (PD)(Baseline - 3months - 6 months)
- Plaque (P)(Baseline - 3months - 6 months)
- Bleeding on probing (BoP)(Baseline - 3months - 6 months)
- 3D Measurements(Baseline - 3months - 6 months)
- Analysis of 2D Gingival Thickness Changes(Baseline - 3months - 6 months)
- Relative gingival recession (rGR)(Baseline - 3months - 6 months)