A comparative clinical evaluation of the treatment outcomes of an autologus fibroblast seeded volume stable collagen matrix vs volume stable collagen matrix alone in class I and class II gingival recession defects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- RD-recession depth
研究概览
简要总结
Gingival recession is defined as exposure of the root surface or the apical shift of the gingival margin from the cemento-enamel junction( CEJ) with a multifactorial etiology, leading to hypersensitivity. Gingival fibroblasts are known to play a critical role in periodontal wound healing and regeneration. The autogenous connective tissue graft (CTG) is considered as the gold standard in the management of gingival recession, but the associated donor site morbidity hinders its widespread applicability. Since then, allogenic and xenogenic collagen matrices have found its way in the repertoire of various periodontal treatment modalities for gingival management. The purpose of this trial is to study the clinical efficacy of one such volume stable collagen matrix (Fibro-Gide)which is of xenogenic in origin, resorbable and specifically designed for soft-tissue regeneration. It is made of reconstituted collagen and undergoes smart chemical cross-linking to improve its volume stability while maintaining a good biocompatibility. The study also aims to study and compare the above matrix with autologous fibroblast seeded on to it in the treatment of class I class II gingival recession defects, wherein the fibroblasts are known to have an important role in the regeneration of periodontal ligament along with the volume stable collagen matrix ( Fibro-Gide) which further supports angiogenesis, formation of new connective tissue and stability of the collagen network in the surrounding soft-tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •18 to 40 years of age Systemically healthy patient Patients having Class I/II gingival recession Patients exhibiting good oral hygiene.
排除标准
- •Pregnant and Lactating women.
- •Medically compromised patients.
- •Patients with known history of allergy.
结局指标
主要结局
RD-recession depth
时间窗: Base line | 1 month | 3 month | 6 month
RW-recession width
时间窗: Base line | 1 month | 3 month | 6 month
complete root coverage (CRC)
时间窗: Base line | 1 month | 3 month | 6 month
次要结局
- WKT-Width of Keratinized Tissue(KT-Keratinized Tissue Thickness)
