The Effect of Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix for the Treatment of Multiple Adjacent Gingival Recessions: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Keratinized tissue width gain
研究概览
简要总结
The present randomized clinical trial is aimed at evaluating the efficacy of recombinant human platelet-derived growth factor in combination with collagen matrix for the treatment of multiple adjacent gingival recessions
详细描述
Despite the fact that gingival recession is most often a generalized condition rather than being localized to a single tooth, most of the data currently found in the literature pertains to the treatment of localized gingival recessions.
The gold standard treatment for this condition involves the use of an autogenous connective tissue graft, that is associated with increased patient morbidity.
Biomaterials have progressively gained popularity due to their advantages when compared to autogenous grafts, such as unrestricted availability, avoidance of a secondary surgical site, reduction of the surgical time, and the patient's preference.
Collagen matrix is one of the most used soft tissue substitute for the treatment of gingival recessions. Combining this scaffold material with a growth factor could enhance its outcomes. In particular, root coverage using platelet-derived growth factor can also promote regeneration of new cementum, periodontal ligament and bone.
Therefore, the aim of the present study is to investigate the effect of platelet-derived growth factor in combination with collagen matrix outcomes for the treatment of multiple adjacent gingival recessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Periodontally and systemically healthy
- •Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
- •At least two multiple adjacent gingival recessions (with at least one 2 mm or deeper) requiring surgical intervention for root coverage
- •No interproximal attachment/bone loss
- •No prior experience of root coverage procedures within the last 1 year
- •The patient must be able to perform good oral hygiene
排除标准
- •Contraindications for periodontal surgery
- •Patients pregnant or attempting to get pregnant (self-reported)
- •Untreated periodontitis
- •Persistence of uncorrected gingival trauma from traumatic toothbrushing
- •Interdental attachment loss greater than 1 mm or furcation involvement in the teeth to be treated
- •Presence of severe tooth malposition, rotation or clinically significant super-eruption
- •Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking
- •Allergy to collagen-based medical products
结局指标
主要结局
Keratinized tissue width gain
时间窗: 6 months
amount of keratinized tissue width gain from the baseline
Gingival thickness gain
时间窗: 6 months
amount of gingival thickness gain from the baseline
Mean Root Coverage
时间窗: 6 months
amount of recession reduction compared to the baseline recession depth
次要结局
- 3D volumetric changes(6 months)
- Esthetic outcomes(6 months)
- Patient-related outcomes(6 months)
- Tissue perfusion variations(6 months)
研究者
Lorenzo Tavelli
Principal Investigator
University of Michigan