Clinical Evaluation of Vertical Inter-implant Papilla Height in Platform Matched Implants in Comparison to Morse Connection Abutments: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Vertical papilla height
研究概览
简要总结
The complete fill of the inter-implant mucosa is much more challenging between two implants, than single implants, and is considered to be unpredictable (Tymstra et al., 2011). However, previous clinical studies have pointed to a relationship between the inter-implant mucosa fill and the horizontal distance between two adjacent implants. In particular, a greater inter-implant bone loss and the absence of the inter-implant mucosa were noted when neighboring implants were not separated by more than 3 mm (Tarnow, Magner and Fletcher, 1992).
The implant-abutment connection may have an impact on the amount such inter-implant bone loss, with morse-taper (MT) abutments emerging from the central region of the implant allow additional thickness in the horizontal soft-tissue component. This might help reducing marginal bone remodeling during biological width formation. Moreover, the literature indicates that the peri-implant bone strain vary significantly with the type of implant-abutment connection. The conical interface of MT connections helps dissipating the forces to the fixture.
The aim of the study is to clinically investigate the fate of soft tissue and papilla following crown placement on neighboring morse cone implants versus non-platform switched implants denoting the fate of soft tissue and papilla.
详细描述
- Study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Oral and Dental Medicine - Cairo University, Egypt.
- Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.
Intervention:
Clinical examination:
- Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, occlusion and inter-arch space.
- Evaluation of the periapical condition and crestal bone level using a periapical radiograph.
- Evaluation of the soft tissue biotype by trans-gingival piercing using a periodontal probe.
- Width of keratinized gingiva (measured by a periodontal probe from the gingival margin to the mucogingival junction). It is measured at three areas (mesial, midbuccal and distal).
SURGICAL PROTOCOL (T0):
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients.
- •Good oral hygiene.
- •Missing minimum of two neighboring maxillary teeth with sufficient bucco-palatal bone of ≥ 6mm.
- •Interimplant distance planned to be 3-4 mm.
- •Patient acceptance of more than one year of follow up.
排除标准
- •Vertically deficient ridges. (≤10 mm)
- •Pregnant females.
- •Thin biotype
研究组 & 干预措施
Cone Morse Connection Implants
2 neighboring Morse connection Implants
干预措施: Morse connection Implants (Combination Product)
platform matched implants
2 neighboring platform matched implants.
干预措施: Morse connection Implants (Combination Product)
结局指标
主要结局
Vertical papilla height
时间窗: 6,12 months from T0 (Implant insertion)
Change will be measured using periodontal probe in millimeters,
次要结局
- Pink esthetic score (PES)(12 months from T0 (Implant insertion))
- Bleeding on probing (BOP)(at T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion).)
- Probing depth (PD)(3, 6,12 months from T0 (Implant insertion))
- Crestal bone resorption(T0 at the time of implant insertion, T1 at 3 months after implant insertion and at T3 at 12 months after implant insertion.)
- Width of buccal keratinized mucosa (KM)(3, 6,12 months from T0 (Implant insertion))
- Patient satisfaction (cleaning, food impaction)(At T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion).)
研究者
Nada Zazou
Principle Investigator, assistant Lecturer, Modern Sciences and Arts University (MSA).
Cairo University