Soft Tissue Augmentation Using Coronally Advanced Flap With Either Subepithelial Connective Tissue and Vitamin C Versus Subepithelial Connective Tissue Graft Alone in Management of RT1 Gingival Recession
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Ginigval thickness
研究概览
简要总结
Compare gingival thickness following CAF With SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession.
详细描述
Control group (coronally advanced flap and subepithelial connective tissue graft alone) Test group (coronally advanced flap and subepithelial connective tissue graft using microsurgical approach) Same procedure will be executed but with the addition of vitamin C injection. Intraepidermal injection (oral mesotherapy technique) of 1-1.5 ml (200-300 mg concentration) of L-ascorbic acid will be done. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (30 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Vitamin C will be injected first time immediately postsurgical and then repeated once per week for 3 consecutive weeks for a total of 4 injections.
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 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years or older.
- •Periodontally and systemically healthy.
- •Buccal recession defects classified as Cairo RT
- •Presence of identifiable CEJ (Zucchelli et al., 2010).
- •Clinical indication and/or patient request for recession coverage.
- •O'Leary index less than 20% (O'Leary, Drake and Naylor, 1972).
排除标准
- •Cairo RT2 or RT3 recession defects.
- •Pregnant females.
- •Smokers as smoking is a contraindication for any periodontal plastic surgery (Khuller, 2009).
- •Handicapped and mentally retarded patients.
- •Patients undergoing radiotherapy.
- •Teeth with cervical restorations, abrasion and malalignment.
- •Presence of systemic disease that would affect wound healing.
结局指标
主要结局
Ginigval thickness
时间窗: 6 months
Determined 2 mm apical to the gingival margin with a short needle for anesthesia and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface is felt. The silicon disk stop is then placed in tight contact with the soft tissue surface with the coronal border overlapping the soft tissue margin. As the needle is located in the center of the silicon disk, measurement of GT is performed 2 mm apical from the gingival margin. Once in the correct position, the disk is fixed with a drop of cyanocrylic adhesive; after careful removal of the needle, the penetration depth is measured with a caliper accurate to the nearest 0.1 mm.
次要结局
- Clinical Attachment Level (CAL)(6 months)
- Post-Operative Pain(2 weeks)
- Root Coverage Esthetic Score(6 months)
- Early Healing Index(6 months)
- Gingival Recession Depth (RD)(6 months)
- Gingival Recession Width (RW)(6 months)
- Percentage of root coverage(6 months)
- Post-Surgical Patient Satisfaction(6 months)
- Probing Depth (PD)(6 months)
- Height of Keratinized Tissue (KTH)(6 months)
研究者
Andrew Albert Anwar Zaki
Principal Investigator
Cairo University