Comparative Evaluation of Microneedling Assisted iPRF with and without Hyaluronic acid 2 percent Management of Anterior Maxillary Black Triangles A split mouth randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the Papillary Fill using JemtPapillary Index 1977 at baseline
研究概览
简要总结
This splitmouth randomized controlled trial aims to evaluate and compare the effectiveness of microneedlingassisted delivery of injectable platelet rich fibrin alone versus iPRF combined with 2 percent hyaluronic acid in managing anterior maxillary black triangles caused by interdental papilla loss. Loss of papilla leads to esthetic and functional issues and while surgical treatments are invasive and unpredictable, microneedling and regenerative biomaterials like iPRF and HA offer minimally invasive alternatives Microneedling creates controlled microinjuries to stimulate collagen production and tissue regeneration while iPRF releases growth factors enhancing healing and HA maintains tissue hydration and promotes regeneration In this study papillary fill width height and black triangle area will be assessed at baseline 1 3 and 6 months along with patientreported outcomes on pain and satisfaction Eighty sites will be included divided equally between the two treatment groups The study will be conducted over six months in the Department of Periodontology and Implantology to determine whether the combination of iPRF and HA provides superior results compared to iPRF alone in regenerating interdental papilla and improving esthetics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy patients aged 20 to 75 years Patient with healthy and stable soft tissue architecture Patients presenting with Class 0 1 and 2 interdental papillary loss in the anterior maxilla as defined by the Jemt Papillary Index 1994 Patients with a probing depth of less than 4 mm Patients with a gingival and plaque index of 0 to 1.
排除标准
- •Patients with systemic diseases that would have influenced bone or soft tissue metabolism Pregnant or lactating females Tobacco smokers.
- •Patient with a history of periodontal surgery in the last six months Patients treated with any medication known to cause gingival hyperplasia Patients with a history of allergic reactions drug and alcohol abuse.
结局指标
主要结局
To evaluate the Papillary Fill using JemtPapillary Index 1977 at baseline
时间窗: To evaluate the Papillary Fill using JemtPapillary Index 1977 at baseline | To evaluate the Papillary gain using Jemt Papillary Index 1977 at 1 3 and 6 months post treatment. | To measure the Papillary Width PW at baseline and 1 3 and 6 months post treatment | To evaluate the Papillary Deficient Height PH at baselineand 1 3 and 6 months post treatment | To estimate the area of the black triangle AoP at baseline and 1 3 and 6 months post treatment
To evaluate the Papillary gain using Jemt Papillary Index 1977 at 1 3 and 6 months post treatment.
时间窗: To evaluate the Papillary Fill using JemtPapillary Index 1977 at baseline | To evaluate the Papillary gain using Jemt Papillary Index 1977 at 1 3 and 6 months post treatment. | To measure the Papillary Width PW at baseline and 1 3 and 6 months post treatment | To evaluate the Papillary Deficient Height PH at baselineand 1 3 and 6 months post treatment | To estimate the area of the black triangle AoP at baseline and 1 3 and 6 months post treatment
To measure the Papillary Width PW at baseline and 1 3 and 6 months post treatment
时间窗: To evaluate the Papillary Fill using JemtPapillary Index 1977 at baseline | To evaluate the Papillary gain using Jemt Papillary Index 1977 at 1 3 and 6 months post treatment. | To measure the Papillary Width PW at baseline and 1 3 and 6 months post treatment | To evaluate the Papillary Deficient Height PH at baselineand 1 3 and 6 months post treatment | To estimate the area of the black triangle AoP at baseline and 1 3 and 6 months post treatment
To evaluate the Papillary Deficient Height PH at baselineand 1 3 and 6 months post treatment
时间窗: To evaluate the Papillary Fill using JemtPapillary Index 1977 at baseline | To evaluate the Papillary gain using Jemt Papillary Index 1977 at 1 3 and 6 months post treatment. | To measure the Papillary Width PW at baseline and 1 3 and 6 months post treatment | To evaluate the Papillary Deficient Height PH at baselineand 1 3 and 6 months post treatment | To estimate the area of the black triangle AoP at baseline and 1 3 and 6 months post treatment
To estimate the area of the black triangle AoP at baseline and 1 3 and 6 months post treatment
时间窗: To evaluate the Papillary Fill using JemtPapillary Index 1977 at baseline | To evaluate the Papillary gain using Jemt Papillary Index 1977 at 1 3 and 6 months post treatment. | To measure the Papillary Width PW at baseline and 1 3 and 6 months post treatment | To evaluate the Papillary Deficient Height PH at baselineand 1 3 and 6 months post treatment | To estimate the area of the black triangle AoP at baseline and 1 3 and 6 months post treatment
次要结局
- To evaluate patient reported outcomes at baseline and 6 months using VAS pain assessment scale and a questionnaire
研究者
Dr Vrushali Lathiya
Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur