Evaluation of Soft Tissue Biotype and Volume Stability After Soft Tissue Augmentation by Using Mucograft® Versus Partially De-epithelized Connective Tissue Graft to Enhance the Pontic Site in Single Missing Tooth With Deficient Ridge: Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa)
研究概览
简要总结
in patients with vertical or horizontal defective of there ridge it is difficult to have prosthetic restoration with natural appearance emetating and simulating the adjacent abutment emergence profile so this study aims to develop the defective area using two different materials of soft tissue grafting techniques to restore the missing tissue and regain soft tissue volume and profile
详细描述
PICO P: single pontic site with deficient ridge. I: Soft tissue augmentation with partially de-epithelized connective tissue graft.
C: Soft tissue augmentation with Mucograft. O: Soft tissue biotype, Soft tissue volume, pain score and patient satisfaction.
Preoperative measures:
- All subjects will pass through phase I therapy (Supragingival scalling, subgingival debridement and oral hygiene instructions) before any surgical procedures.
- After 4 weeks, all subjects will be examined to determine patient compliance with oral hygiene procedures (tooth brushing twice daily and chlorhexidine HCL 1.25% mouthwash twice daily).
- Eligible patients will be randomized before being enrolled in the study. (T-1 +4 weeks)
- Study casts for case study will be fabricated and clinical photographs will be taken.
- Assessment of edentulous defect site and neighboring teeth will be performed by scanning the study casts.
Surgical phase (T0):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single missing tooth and the patient decides to have fixed prosthesis as a treatment option for tooth replacement.
- •Horizontal and\or vertical ridge defect at the pontic site
- •Sufficient inter-arch distance.
- •Restorable neighbouring abutments.
- •Periodontally sound abutments.
- •Skilled and motivated patient in maintaining good oral hygiene.
排除标准
- •Multiple neighboring missing teeth.
- •Systemic diseases that could affect treatment outcome.
- •Poor oral hygiene.
- •Patient is not motivated to have the treatment.
结局指标
主要结局
Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa)
时间窗: 6 month
% of the change in soft tissue thickness of keratinized mucosa through Trans mucosal probing by periodontal probe.
次要结局
- soft tissue stability (% of the difference between baseline and post-opertively results through measuring from the crest of edentulous area to Mucogingival line by periodontal prob)(6 month)
研究者
Nouran Abdulla Mater,MD
Lectural assistant
Cairo University