Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using Connective Tissue Graft Around Immediate Dental Implants Versus Immediate Dental Implants Alone in the Esthetic Zone. Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Facial gingival level
研究概览
简要总结
Aim of current study to evaluate connective tissue graft combined with immediate implant placement as an innovative option for less facial gingival tissue recession, less pocket depth and less clinical attachment loss versus immediate implant alone.
详细描述
P: Adult patients with single or multiple non-restorable teeth in esthetic zone I: Immediate implant + Connective tissue graft. C: Immediate implant alone. O: Primary Outcome: Facial gingival level Secondary Outcome: Patient satisfaction, probing depth, probing attachment loss, tissue biotype, keratinized mucosal width and bleeding on probing.
P.M will select patients from the outpatient clinic of the Oral Medicine and Periodontology Department - Cairo University. Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blinded participants: patient will be ensured by masking the instruments during the surgery. The patient will be informed of the steps of the surgery (as mentioned in the consent form) without getting into details. Blinding to the clinical, radiographic assessors is done by not involving them in sequence generation or allocation concealment or surgery performing.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with single or multiple non-restorable teeth in maxillary anterior or premolar area.
- •Patients with adequate bone volume for the dental implant procedure.
- •Patients who are compliant to oral hygiene measures.
- •Patient consent approval and signing.
排除标准
- •Heavy smokers.
- •Systemic disease that contraindicates implant placement or surgical procedures.
- •No or poor patient's compliance.
- •Psychological problems.
- •Pathology at the site of intervention.
- •Pregnancy females.
结局指标
主要结局
Facial gingival level
时间窗: Up to 6 months
FGL was evaluated by measuring the distance between the level of soft tissues and the lower border of the customized template that was used as a reference line at three readings mesially, mid-facially and distally.
次要结局
- Pain score(Up to 12 days)
- Pink esthetic score(Up to 6 months)
- Probing attachment level(Up to 6 months)
- Width of keratinized mucosa(Up to 6 months)
- Patient satisfaction(Up to 6 month)
- Tissue biotype(Up to 6 months)
- Bleeding on probing(Up to 6 months)
- Probing depth(Up to 6 months)
研究者
Parryhan Mohamed Abdelsamie
Assistant lecturer
Cairo University