COMPARATIVE EVALUATION OF RECESSION COVERAGE FOLLOWING THE USE OF ADJUNCTIVE PHOTOBIOMODULATION OR BIOFUNCTIONALIZATION WITH EMDOGAIN FOR THE MANAGEMENT OF ISOLATED GINGIVAL RECESSION- A 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
- 32
- 试验地点
- 1
- 主要终点
- mean and complete root coverage percentages
研究概览
简要总结
Gingival recession (GR) is a common mucogingival deformity with a global prevalence of 78.16%, most frequently affecting mandibular anteriors. It is defined as the apical shift of the gingival margin beyond the cementoenamel junction, leading to root surface exposure, dentin hypersensitivity, esthetic concerns, and root caries. Risk factors include a thin biotype, lack of attached gingiva, bone deficiencies, tooth malposition, and high frenum attachment. With rising esthetic demands, managing GR is essential for both periodontal health and optimal functional outcomes. Coronally Advanced Flap (CAF) with Connective Tissue Graft (CTG) is considered the gold standard, achieving predictable root coverage (61.24–99%), while adjunctive therapies aim to further enhance clinical outcomes by improving wound healing and tissue regeneration. Photobiomodulation (PBM) therapy, utilizing low-level diode lasers (660–980 nm, 0.05–0.5 W), stimulates mitochondrial ATP production, accelerating wound healing, promoting neovascularization, reducing dentinal hypersensitivity, and modulating inflammation. Studies suggest PBM enhances root coverage and patient comfort. Enamel Matrix Derivatives (EMD), such as Emdogain, mimic the natural tooth development process, promoting angiogenesis, fibroblast proliferation, osteoblast differentiation, and anti-inflammatory effects. Systematic reviews indicate that EMD significantly improves complete root coverage when used as an adjunct to CAF. Additionally, studies suggest that combining EMD with CTG enhances clinical outcomes, including recession depth reduction and attachment gain. Despite the well-documented individual benefits of PBM and EMD, comparative evaluations of these adjuncts with CAF+CTG are limited. This randomized controlled clinical trial aims to systematically compare the efficacy of CAF+CTG with adjunctive PBM and CAF+CTG with adjunctive EMD in improving clinical parameters and patient-reported outcomes, bridging this knowledge gap and optimizing treatment approaches for gingival recession management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor 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
- •Systemically healthy patients Presence of isolated (single tooth) Cairo’s RT1 (RT1-gingival recession with no loss of interproximal atatchment) Patients with no medication known to interfere with periodontal tissue health/healing (steroids, calcium channel blockers, antiepileptic agents, immune-suppressants) Non-smoker (= never smoker), or former smoker (= does not smoke now and has not smoked at all for a minimum of the last 12 consecutive months).
排除标准
- •Patients with abusive habits such as smoking and tobacco chewing Patients with systemic diseases such as Diabetes mellitus, Hypertension.
- •Immunocompromised patients Lingual recession in the selected teeth Presence of malocclusion/patients with orthodontic therapy in progress and Previous history of surgical periodontal therapy.
结局指标
主要结局
mean and complete root coverage percentages
时间窗: 1,3,6months
次要结局
- wound healing, root coverage esthetic score and patient reported outcome measures(1,3,6months)
研究者
Deebika D
DEPARTMENT OF PERIODONTOLOGY, SRI RAMACHANDRA DENTAL COLLEGE AND HOSPITAL
