Effect of Soft Tissue Volume on Midfacial Gingival Margin Alterations Following Immediate Implant Placement in the Esthetic Zone: A 1-Year Randomized Clinical and Volumetric Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Midfacial Gingival Margin Changes
研究概览
简要总结
Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize and control midfacial gingival recession and support buccal soft tissue contour, and maintain long term stability of these tissue, which might enhance the esthetics
详细描述
Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patient-related criteria:
- •Adults at or above the age of
- •Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
- •The failing tooth will have adjacent and opposing natural teeth.
- •Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
- •Able to tolerate surgical periodontal procedures.
- •Good oral hygiene.
- •Compliance with the maintenance program.
- •Provide informed consent.
- •Accepts the one-year follow-up period.
- •Teeth related criteria:
- •Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
- •Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
- •Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm
排除标准
- •Patients diagnosed with periodontal diseases.
- •Current or previous smokers.
- •Pregnant and lactating females.
- •Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
- •Patients with active infection related at the site of implant/bone graft placement.
- •Patients with parafunctional habits
结局指标
主要结局
Midfacial Gingival Margin Changes
时间窗: 12 months
will be assessed by measuring the distance between level of soft tissues at mid-facial gingival level of the implant site and a reference line, which connected the facial soft tissue level of the adjacent teeth, at baseline, 3, 6 and 12 months of follow up.
次要结局
- Bone labial to the implant(12 months)
- Volumetric analysis of buccal contour&Total Volume(12 months)
研究者
Ahmed Aboulfettouh
Dr. Ahmed Ibrahim AboulFettouh
Cairo University