Comparative evaluation of gingival tissue augmentation using hyaluronic acid alone and with micro-needling : A randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To increase the gingival thickness
研究概览
简要总结
This study is a randomized, outcome assessor blinded, parallel group, single center trial comparing the efficacy of 0.1 ml of injectable hyaluronic acid filler on one side, injected just below the mucogingival junction and 0.1 ml of injectable hyaluronic acid filler with micro-needling using 30 gauge lancet needle which is inserted until hard tissue is felt on the keratinized gingiva from mesial side of the central incisor to the distal part of canine on other side after initial scaling 1 week prior to the commencement of the interventional study in patient with thin gingival biotype with <0.8mm of gingival thickness. The primary outcome is to assess the thickness of the keratinized gingiva after 15 days, 1 month, 2 month and 3 months after the treatment.
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
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy patients.
- •Mandibular anterior teeth <0.8 mm gingival thickness.
- •Full mouth plaque index and BOP score of <15 % Gingival index < 1 % score.
排除标准
- •patient with known systemic disease.
- •Patient underwent treatment with antibiotics within last three months.
- •Patient who underwent treatment with anti-inflammatory drug within the last three months.
- •Patient undergoing orthodontic treatment.
- •Patient who underwent periodontal therapy within the last six months.
- •Pregnancy or use of oral contraceptive.
- •Patient using blood thinners.
- •Patient on medications which will lead to gingival enlargement.
- •Malocclusion.
结局指标
主要结局
To increase the gingival thickness
时间窗: Baseline | 15 days | 1 month | 2 month | 3 month
次要结局
未报告次要终点