Evaluation of root coverage using collagen matrix (Mucograftâ„¢)and sub epithelial connective tissue graft (SCTG) with modified coronally advanced tunnel technique (MCAT) in the treatment of multiple gingival recessions in smokers-A prospective randomized controlled clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Amount of root coverage in terms of width and depth (Relative Attachement Level)
研究概览
简要总结
| The challenge for periodontal plastic surgical procedures is to achieve stable and complete root coverage with an attachment of the tissue margin at the CEJ as well as to increase the dimensions, i.e., thickness and width of keratinized gingiva and to maintain healthy gingival sulcus. |
A variety of surgical techniques such as laterally positioned pedicle graft, free gingival graft, subepithelial connective tissue graft (SCTG), coronally advanced flap, guided tissue regeneration along with biologic mediators like platelet rich fibrin (PRF) etc. have been evaluated in the last few decades to obtain root coverage with predictability and consistency for Multiple Adjacent Gingival Recession. SCTG is considered as a gold standard. However, longer surgical time and an increase in patient morbidity in the treatment of multiple adjacent gingival recessions using SCTG have become a challenge to both clinician and patient. To overcome the drawbacks of patient morbidity during harvest of SCTG other alternatives such as Allografts and Guided tissue regeneration are available but have their own limitations. One such newly developed alternative is a porcine-derived collagen matrix.The Mucograftâ„¢ was introduced by Giestlich company.
Determinants of a successful root coverage procedure include operative technique, defect characteristics, and patient attributes. Among the patient-related factors, cigarette smoking is known to negatively influence the healing outcome following periodontal surgical procedures, including grafting for root coverage.
The main aim of this prospective randomized controlled clinical trial is to evaluate the outcome of root coverage with Collagen Matrix (Mucograftâ„¢ ) and SCTG using the MCAT technique in smokers.
parameters are
Amount of root coverage in terms of width and depth
Increase in the width and thickness of Keratinized Gingivitis
Percentage of root coverage
Patient Morbidity using Visual Analogue Scale. ( pain, Dentinal Hypersensitivity)
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients aged between 18 to 60 years
- •Smokers who smoke on an average of ≥ 5 Cigarettes per day
- •Systemically Healthy with no contraindications for periodontal surgery
- •Presence of ≥ 2 adjacent Millers Class I and Class II Recessions
- •Absence of clinical signs of active periodontal disease.
排除标准
- •Malpoistioned teeth
- •Active (or) untreated gingival and periodontal disease
- •Any systemic conditions that would interfere with healing
- •Pregnant or lactating women
- •Patients treated with any medication known to affect the gingival condition.
- •Patients who are not willing to comply with smoking cessation protocol.
结局指标
主要结局
Amount of root coverage in terms of width and depth (Relative Attachement Level)
时间窗: Baseline | 3 months | 6 months
Increase in the width of Keratinized Gingiva
时间窗: Baseline | 3 months | 6 months
Improvement in Gingival Biotype
时间窗: Baseline | 3 months | 6 months
Percentage of root coverage
时间窗: Baseline | 3 months | 6 months
Time taken for the procedure
时间窗: Baseline | 3 months | 6 months
Patient Morbidity using Visual Analogue Scale. ( Discomfort, Dentinal Hypersensitivity)
时间窗: Baseline | 3 months | 6 months
次要结局
- Percentage of root coverage(6 months)