Clinical and Aesthetic Evaluation of Hyaluronic Acid in Addition to Connective Tissue Grafts in the Treatment of Gingival Recession Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Impact of Adjunctive Hyaluronic Acid on Mean Root Coverage After Recession Treatment
研究概览
简要总结
This study evaluates whether adding 0.8% hyaluronic acid (HA) to connective tissue grafting and coronally advanced flap surgery improves clinical and esthetic outcomes in the treatment of gingival recession. Adult patients with Miller I-II or Cairo RT1 recession defects will be randomly assigned to receive CTG alone or CTG with adjunctive HA. Mean root coverage at 6 months is the primary outcome, while secondary measures include gingival thickness, clinical attachment level, esthetic scores, postoperative morbidity, and quality of life. The study aims to determine whether HA enhances soft tissue healing and root coverage predictability compared with conventional CTG.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least one gingival recession defect classified as Cairo RT1 or Miller Class I-II with a minimum depth of 1 mm.
- •Full-mouth plaque score (FMPS) and full-mouth bleeding on probing (FMBOP) < 15%.
- •Detectable cemento-enamel junction (CEJ).
- •Age ≥ 18 years.
- •No history of prior periodontal surgical treatment.
- •Sufficient mental capacity to understand the study aims and procedures explained verbally and in writing.
- •Determined to be cooperative and compliant with the clinician before, during, and after the surgical procedure.
排除标准
- •Patients younger than 18 years.
- •Periodontally healthy individuals.
- •Current smokers.
- •History of periodontal treatment within the past 1 year.
- •Use of antibiotics within the past 3 months.
- •Pregnancy or breastfeeding.
- •Presence of systemic diseases such as diabetes, chronic kidney failure, cancer, bleeding disorders, connective tissue diseases, or other chronic conditions; and gingival recessions classified as Cairo RT
- •Presence of cervical caries or restorations at the defect site.
研究组 & 干预措施
Experimental - CTG + Hyaluronic Acid
A 0.8% hyaluronic acid (HA) gel is applied to the connective tissue graft (CTG) before flap closure during the coronally advanced flap (CAF) procedure. The HA gel is used as an adjunctive biologic material to potentially enhance wound healing, soft tissue thickness, esthetic outcomes, and overall root coverage performance.
干预措施: Hyaluronic Acid (0.8%) - Applied over CTG before flap closure (Test group only). (Biological)
CTG only
A standardized coronally advanced flap (CAF) procedure combined with a subepithelial connective tissue graft (CTG) is performed to treat gingival recession defects. The surgical protocol includes flap elevation, graft harvesting and placement, and flap advancement and suturing.
干预措施: Connective Tissue Graft + Coronally Advanced Flap (CTG + CAF) (Procedure)
Experimental - CTG + Hyaluronic Acid
A 0.8% hyaluronic acid (HA) gel is applied to the connective tissue graft (CTG) before flap closure during the coronally advanced flap (CAF) procedure. The HA gel is used as an adjunctive biologic material to potentially enhance wound healing, soft tissue thickness, esthetic outcomes, and overall root coverage performance.
干预措施: Connective Tissue Graft + Coronally Advanced Flap (CTG + CAF) (Procedure)
结局指标
主要结局
Impact of Adjunctive Hyaluronic Acid on Mean Root Coverage After Recession Treatment
时间窗: From enrollment to the end of treatment at 6 months"
The primary objective of this study is to evaluate the effect of adjunctive hyaluronic acid (HA) on the mean root coverage (MRC) achieved after the treatment of gingival recession defects.
次要结局
未报告次要终点
研究者
Şeyma Çardakçı
asst. professor
Saglik Bilimleri Universitesi