Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Gingival Thickness
研究概览
简要总结
The aim of this study will be to clinically assess the soft tissue augmentation achieved by the de-epithelialized free gingival graft with coronally advanced flap versus the subepithelial connective tissue graft with coronally advanced flap as root coverage procedures for management of patients with Miller class I and II gingival recession.
详细描述
Evidence from the literature showed that coronally advanced flap was a predictable method for root coverage. The addition of a connective tissue graft was also found to improve the outcome of obtaining complete root coverage in Miller class I and II gingival recession. Many different connective tissue graft-harvesting techniques have been utilized. These techniques aimed at reducing patient morbidity by primary closure of the palatal flap to achieve primary intention wound healing. However, they had the limitation of requiring an adequate thickness of the palatal fibromucosa in order to prevent desquamation of the undermined flap and compromised vasculature.
On the other hand, the free gingival graft surgical technique was also unaccepted esthetically due to the white scar and irregularities produced at the monolingual junction.
Moreover, despite the fact that the free gingival graft had its limitation of being associated with greater post-operative pain, discomfort and bleeding due to healing by secondary intention in 2-4 weeks, nevertheless, this technique was much easier to perform and could be used even in cases of thin palatal fibromucosa.
The evidence in literature comparing patient morbidity and root coverage outcomes between these two techniques is minimal. Studies by Griffin et al. (2006) and Wessel and Tatakis (2008) reported increased incidence of post-operative pain with free gingival grafts. However, a recently study by Zucchelli et al. (2010) compared post-operative morbidity and root coverage outcomes in patients treated with trap-door connective tissue graft and de-epithelialized free gingival graft found no statistically significant differences in pain killer consumption, post-operative discomfort and bleeding between the two groups.
Still very few studies measured the effect of different connective tissue graft harvesting techniques on gingival thickness. And even in the study by Zucchelli et al. (2010), only speculative explanation was given regarding the increase of gingival thickness in case of a de-epithelialized free gingival graft than subepithelial connective tissue graft.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Single blinded:
- Blinding of the participants is not applicable.
- Blinding of the operator is not applicable.
- Outcome assessor (primary and secondary outcomes) & biostatistician will be blinded.
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
- •Patients 18 years or older.
- •Periodontally and systemically healthy.
- •Buccal recession defects classified as either Miller class I or II.
- •Presence of identifiable Cementoenamel juction (Zucchelli et al., 2010).
- •Clinical indication and/or patient request for recession coverage.
- •O'Leary index less than 20% (O'Leary et al., 1972).
排除标准
- •Miller class III or IV recession defects.
- •Pregnant females.
- •Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- •Handicapped and mentally retarded patients.
- •Patients undergoing radiotherapy.
- •Teeth with cervical restorations, abrasion.
- •Presence of systemic disease that would affect wound healing.
研究组 & 干预措施
Subepithelial connective tissue graft
Patients will receive a coronally advanced flap surgery with a subepithelial connective tissue graft for recession coverage.
干预措施: Coronally advanced flap and subepithelial connective tissue graft (Procedure)
De-epithelialized free gingival graft
Patients will receive a coronally advanced flap surgery with a de-epithelialized free gingival graft for recession coverage.
干预措施: Coronally advanced flap and deepithelialized free gingival graft (Procedure)
结局指标
主要结局
Gingival Thickness
时间窗: 6 months
Thickness of the gingival tissues 2 mm from the free gingival margin
次要结局
- Post-Operative Pain(Two weeks)
- Post-operative bleeding(Two weeks)
- Post-Surgical Patient Satisfaction(6 months)
- Root coverage esthetic score(6 months)
- Post-operative stress(Two weeks)
- Post-operative inability to chew(Two weeks)
- Percentage of root coverage(6 months)
研究者
Mohamed Mashaly
Principal investigator
Cairo University