Evaluation of the clinical efficacy of platelet rich fibrin obtained through the horizontal spin technique along with coronally advanced flap and connective tissue graft obtained by de-epithelized free gingival graft in the treatment of gingival recession - A Prospective comparative clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1.To assess and compare the changes in the recession height (RH)
研究概览
简要总结
Gingival recession is defined as the apical displacement of gingival margin to the cemento enamel junction (CEJ) exposing the root surface (Gustavo et al 2021 ). The causative factors include faulty tooth brushing, underlying periodontal disease, malaligned tooth, high frenal attachment causing marginal gingival pull, subsequently leading to the exposure of root causing esthetic concerns hypersensitivity, plaque retention and caries to the patients. Among the various surgical treatmentstrategies, the coronally advanced flap technique (CAF) combined with connective tissue graft (CTG) is considered as the gold standard protocol in the management of gingival recession resulting in complete root coverage along with improving keratinized tissue height and gingival thickness. A recent modification by zuchelliet al (2010), known as De-epithealized gingival graft (DGG) enables the clinician to obtain collagen rich fibrous connective tissue from lamina propria of the palate, with minimal amount of fatty and glandular tissue, than the previously mentioned sub epithelial connective tissue graft harvesting techniques. However, drawbacks of harvesting autogenous grafts include palatal morbidity as a result of the secondary surgical site and the patient’s fear of pain. Studies have reported that horizontal centrifugation of PRF was superior at accumulating platelets and leukocyteswhen compared to the results from standard fixed angle centrifuges **(Richard J.Miron et al 2020).**In this clinical study we propose to compare out comes of the PRF obtained by the horizontal centrifugation method and coronally advanced flap with connective tissue graft (CTG) obtained by de-epithelized FGG for a follow up period up to 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Gingival recession defects in maxillary anteriors and premolars (Cairo’s RT1 & RT2 class of recession)
- •Sites with minimum depth of recession ≥2mm.
- •Isolated or multiple adjoining recession involving ≤3 teeth.
排除标准
- •Sites with probing pocket depth ≥4mm.
- •Teeth with mobility and/or associated with trauma from occlusion.
- •Sites with dental caries and prosthetic restorations.
- •Patients who exhibit unacceptable oral hygiene compliance during/or after phase Ι therapy.
- •Pregnant and lactating women.
- •Patients with known platelet disorders or using any medication that are known to interfere with platelet function.
- •Patients with systemic conditions or disease influencing the course of periodontal disease and therapy.
结局指标
主要结局
1.To assess and compare the changes in the recession height (RH)
时间窗: Baseline and six months
2.To assess and compare the percentage of Complete root coverage (CRC%)
时间窗: Baseline and six months
次要结局
- To evaluate and compare the changes in the following parameters between the study groups before and after therapy(1. Width of keratinised gingiva (WKT))