Comparison of connective tissue graft and platelet rich fibrin as matrices in a novel papillary augmentation access for patients with deficient interdental papilla using microsurgical approach – A randomised controlled clinical trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 1.Papillary height
研究概览
简要总结
The current study proposes, minimal access labial and palatal crevicular incisions, so as to create a tunnel across the interdental gingiva, to facilitate placement of the Connective Tissue Graft in control group and Platelet Rich Fibrin in the test group so as to augment the papilla height under microsurgical approach. The required sample size is a total of 26 patients with 13 patients in each of the two groups.The clinical parameters that were evaluated are PH and BTH which were the primary outcome measures. VASD and VASP were secondary outcome measures along with site specific PPD, CAL, FMPS, FMBS. All the parameters are evaluated and compared at baseline and 6 months. VASD and VASP were evaluated and compared at 6months
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Class I, II and I-II interdental papillary loss based on nordland and tarnow’s classification.
- •2.Recession less than 2mm on the facial aspect.
- •3.No active periodontal disease 4.Patients with adequate width of attached gingiva 5.No systemic conditions or medication known to interfere with periodontal tissue health or healing.
排除标准
- •1.Previous periodontal surgery within six months.
- •2.Pregnant / lactating women 3.Usage of tobacco / tobacco products in past 6 months.
- •4.Patients unwilling for the surgery.
- •5.Patients with inadequate plaque control.
- •6.Edentulous site adjacent to the site of surgery.
- •7.Platelet count less than one lakh cells per cubic mm.
结局指标
主要结局
1.Papillary height
时间窗: At 6th month from baseline
It is measured from the tip of the interdental papilla to the apical extent of the contact point using UNC probe.
时间窗: At 6th month from baseline
It is to be measured from base of the papilla to tip of the papilla using UNC probe.
时间窗: At 6th month from baseline
2. Height of the black triangle
时间窗: At 6th month from baseline
次要结局
- Visual analogue scale is an additional parameter measured as secondary outcome to be analysed at 6 months comparing baseline and 6th month photographs.(Visual analogue scale for papillary fill by a dental professional.)