Evaluation of Omega Roll Envelope Flap for Soft Tissue Augmentation Around Osseointegrated Dental Implants
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Peri-implant soft tissue phenotype
研究概览
简要总结
Abstract Statement of the problem: Peri-implant soft-tissue augmentation procedures can be broadly divided into two groups, depending on their primary therapeutic objective: (1) Peri-implant soft-tissue phenotype modification and (2) Treatment of peri-implant marginal mucosa defects (PMMDs), also known as peri-implant soft-tissue dehiscences.
Aim of the study: The aim of this study will be to evaluate the efficacy of the Omega roll envelope flap (OREF) technique compared to the conventional envelope split-thickness flap technique combined with an autogenous connective tissue graft, in enhancing Peri-implant soft tissue phenotype defined by the gingival thickness, keratinized tissue width, mucosal margin level and interproximal papilla height around implant.
详细描述
Materials and Methods
24 patients complaining of a single missing tooth in the with adjacent intact natural teeth and demanding replacing it with the best possible esthetics will be enrolled and recruited from the outpatient clinic, Faculty of Dentistry, Ain Shams University according to eligibility criteria. They will be randomly allocated to two equal groups. Group A (test group, n=12) will have a single implant placed after receiving non-surgical periodontal therapy and then after 12 weeks at the uncovering of the implant and placement of healing abutment, an Omega roll envelope flap (OREF) technique will be carried out for soft tissue augmentation, while Group B (control group, n=12) same procedures will be done but, soft tissue augmentation will be done by an envelope split-thickness flap combined with a sub-epithelial connective tissue graft. After 3 and 6 months Peri-implant soft tissue phenotype defined by gingival thickness, keratinized tissue width, mucosal margin level and interproximal papilla height around implant will be clinically assessed (1ry outcome). The 2ry outcomes will include comparing between the probing depth and clinical attachment level. Postoperative pain and swelling will be recorded by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be blinded. Data collected will be tabulated and statistically analyzed.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically free patients (American Society of Anesthesiologists (ASA) I. Patients between 18 - 50 years of both genders and able to understand the nature of the proposed surgery and to sign the informed consent. Ability to comply with the study related procedures such as maintaining good oral hygiene and attending all follow-up scheduled appointments. Patients who complained of a single missing tooth bounded with two adjacent natural sound teeth diagnosed with clinical periodontal health. Necessity for soft tissue augmentation in a single tooth gap determined by a concavity that was present in the edentulous area or tissues with thin biotype being ≤2 mm or with inadequate width of ≤4mm. Adequate bone width for implant placement without need for bone augmentation (confirmed by a single pre-operative cone-beam computed tomography) (CBCT).
排除标准
- •Previous soft tissue augmentation in the area. Need for major soft or hard tissue augmentation procedures. Smokers. Patients taking medications that might affect the healing of soft and hard peri-implant tissues.
结局指标
主要结局
Peri-implant soft tissue phenotype
时间窗: Baseline, 3 Months & 6 Months
Measured in millimeters, using UNC-15 Periodontal Probe/Endodontic File with rubber stopper,
次要结局
- Esthetic satisfaction(At 3 and 6 months)
- Probing depth(Baseline, 3 Months & 6 Months)
- Postoperative pain(At the day of the procedure and for 14 days (registered before bedtime at a specific time point for each patient))
- Postoperative swelling(At the day of procedure and for 7 days (registered before bedtime at specific time point for each patient))
- Clinical Attachment Level (CAL)(Baseline, 3 Months & 6 Months)
- Implant soft tissue deficiency Esthetic Score (IDES)(At 6 months)
研究者
Amr Mohamed Saeed Abd El Aziz
Phd Researcher
Ain Shams University