Comparative evaluation of the efficacy of injectable platelet-rich fibrin with microneedling versus vitamin C injection with microneedling in the treatment of Class I interdental papilla defects: A randomized clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in papilla defect height mm measured on standardized intraoral photographs.
研究概览
简要总结
Interdental papilla loss in the anterior esthetic region results in gingival black triangles, which cause esthetic concerns, food lodgment, and plaque retention. Conventional surgical procedures for papilla reconstruction are invasive and unpredictable, while nonsurgical fillers such as hyaluronic acid require repeated applications and increase treatment cost.
Injectable Platelet-Rich Fibrin (I-PRF) is a leukocyte-enriched autologous platelet concentrate that promotes wound healing, collagen formation, and antimicrobial activity. Microneedling enhances delivery of biologics, induces neovascularization, and stimulates collagen induction. Vitamin C plays a critical role in collagen biosynthesis, fibroblast proliferation, and periodontal healing, and when combined with microneedling may further improve papilla regeneration.
The present randomized clinical trial aims to compare the clinical efficacy of I-PRF with microneedling versus Vitamin C with microneedling in the treatment of Class I interdental papilla defects in the maxillary anterior region. The study will evaluate changes in papilla defect height (primary outcome), papilla width, deficient area, deficient volume, and patient-reported esthetic satisfaction (secondary outcomes) over a 12-week follow-up period.
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 45 years (both genders).
- •Presence of at least one Nordland and Tarnow Class I interdental papilla defect in the maxillary anterior region.
- •Selected teeth free of restorations on cervical or proximal surfaces.
- •Patient reports food lodgment or esthetic concern due to open gingival embrasure.
- •Distance between interproximal contact point and alveolar bone crest less than or equal to 7 mm.
排除标准
- •Patients with history of traumatic occlusion.
- •Systemically unhealthy or medically compromised patients.
- •Patients with implants or endodontically treated teeth in the involved area.
- •Pregnant or lactating women.
- •Smokers or alcoholics.
结局指标
主要结局
Change in papilla defect height mm measured on standardized intraoral photographs.
时间窗: baseline 3 weeks 6 weeks and 12 weeks
次要结局
- Change in papilla width mm papilla deficient area mm² papilla deficient volume (mm³), & patient-reported esthetic satisfaction (VAS score).(baseline 3 week 6 weeks & 12 weeks)
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研究者
Dr Sai kamali Mandava
Coorg Institute of Dental Sciences