Comparative evaluation of the efficacy of collagen and amniotic in a non invasive approach to root coverage using pinhole surgical technique - a randomised controlled clinical trial
概览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Both materials are expected to aid wound healing. The amniotic membrane may improve comfort (VAS) and regeneration (CAL). Key clinical measures include: Recession Depth (RD), Recession Width (RW), Keratinized Tissue Width (KTW), Gingival Thickness (GT), Root Coverage (RC) %, Gingival Index (GI), Plaque Index (PI), and Probing Pocket Depth (PPD). If effective, it could be a cost-efficient option for gingival recession treatment.
概览
简要总结
Gingival recession refers to the downward movement of the gum line below the cementoenamel junction, leading to root exposure and loss of attachment. It results from a combination of susceptibility factors (e.g., thin gingival biotype, lack of keratinized tissue) and modifiable conditions (e.g., plaque buildup, traumatic brushing, smoking, and systemic diseases like diabetes).
Understanding the etiology is key for prevention and management, with major causes being plaque-induced inflammation and mechanical trauma from improper brushing. Conventional surgical treatments (e.g., free gingival grafts, coronally advanced flaps) are effective but often invasive and esthetically limiting.
To overcome these challenges, minimally invasive techniques like the Pinhole Surgical Technique (PST) were developed. PST involves small pinholes instead of large incisions, minimizing trauma, eliminating sutures, and improving esthetic outcomes.
Additionally, biomaterials such as collagen membranes and amniotic membranes (AM) are used to enhance healing. AM, derived from human placental tissue, promotes soft tissue healing, supports cell migration, and reduces surgical time due to its self-adhesive nature.
The study proposes to evaluate the effectiveness and predictability of PST in combination with AM for treating marginal tissue recession, aiming to improve clinical outcomes with less invasiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient in the age group of 18 to 60 years.
- •Miller Class I or II gingival recessions affecting the canines, vital anterior teeth, or premolars.
- •The cementoenamel junction (CEJ) must be clearly identifiable, and the gingival thickness in the area of the recession must be at least 1 mm.
- •The individual must exhibit good periodontal health, with no evidence of active periodontal disease or inflammation.
- •Participants also agreed to participate and signed an informed consent form.
排除标准
- •Patients who failed to maintain proper oral hygiene plaque index is greater than 1 after phase 1 therapy.
- •Pregnant or lactating females.
- •Individuals with fully restored teeth, dental mobility, cervical abrasion, caries, or abfraction.
- •Those with a history of prolonged antibiotic use.
- •Smokers and individuals who engage in Tobacco chewing.
结局指标
主要结局
Both materials are expected to aid wound healing. The amniotic membrane may improve comfort (VAS) and regeneration (CAL). Key clinical measures include: Recession Depth (RD), Recession Width (RW), Keratinized Tissue Width (KTW), Gingival Thickness (GT), Root Coverage (RC) %, Gingival Index (GI), Plaque Index (PI), and Probing Pocket Depth (PPD). If effective, it could be a cost-efficient option for gingival recession treatment.
时间窗: follow up at baseline, 3 months and 6 months
次要结局
- Changes in Gingival Index (GI), Plaque Index (PI), and Probing Pocket Depth (PPD) to assess gingival health, oral hygiene status, and periodontal stability throughout the study period.
研究者
Tanvika Mall
Santosh Demeed to be University