Comparison of Peri-implant Soft Tissue Esthetics Around Single Delayed Implant With Immediate Provisionalization Placed in The Esthetic Zone With and Without Using Subepithelial Connective Tissue Graft: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Pink Esthetic Score
研究概览
简要总结
The aim of this study is to clinically evaluate peri-implant soft tissue esthetics around single delayed implants in the esthetic zone.
详细描述
To compare the efficacy of soft tissue augmentation on the peri-implant soft tissue esthetics along with immediate temporization to immediate temporization only.
Population (P): patients with a single missing tooth in the esthetic zone Intervention (I): Delayed implant placement with immediate temporization and subepithelial connective tissue graft Comparator (C): Delayed implant placement with immediate temporization Primary outcome: Pink esthetic score (PES) Time frame: 6 months Study design: Randomized controlled clinical trial
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years old
- •Good medical and psychological health
- •Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients required periodontal treatment (non-surgical and/or surgical), this was arranged outside the study protocol and completed at least 30 days prior to the enrolment
- •Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region
- •Willingness to sign the informed consent form
排除标准
- •Any known disease (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation;
- •Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) within 1 month before baseline visit;
- •Anticoagulant therapy with warfarin, clopidogrel, ticlopidine or once daily aspirin (more than 81 mg);
- •HIV or Hepatitis;
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
- •Alcoholism or chronic drug abuse;
- •Heavy smokers (>10/cigarettes per day);
- •Lack of adequate primary stability at implant insertion that enables immediate provisionalization (insertion torque ca 30 Ncm).
研究组 & 干预措施
Delayed implant placement with immediate provisionalization
Single delayed implant placement in the esthetic zone with placing an immediate temporary crown placed within 48 hours after the surgery
干预措施: delayed implant with immediate provisionaliztion and soft tissue graft (Procedure)
Implant with immediate temporization and soft tissue graft
Single delayed implant placement in the esthetic zone with placing a subepithelial connective tissue graft buccal to the implant and immediate temporary crown within 48 hours after the surgery
干预措施: delayed implant placement with immediate provisionalization (Procedure)
结局指标
主要结局
Pink Esthetic Score
时间窗: 3 months post definitive prosthesis
Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral
次要结局
- Buccal peri-implant soft tissue thickness(3 months post definitive)
- Patient satisfaction by Visual analogue scale (VAS)(3 months post definitive)
- Recession of the buccal peri-implant mucosa(3 months post definitive)
研究者
Dina Osama Abdelwahab Megahed
Resident
Cairo University