Clinical Evaluation of the Effect of Temporization on the Peri-implant Soft Tissue of Immediate Implants: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- change in Pink Esthetic Score (PES)
研究概览
简要总结
This parallel arms, randomized controlled clinical trial will involve 22 systemically free patients with an unrestorable tooth in the upper esthetic zone. They will be randomly allocated to two equal groups. Group A (test group) will receive immediate implants with simultaneous immediate temporization, while group B (control group) will receive immediate implants with no temporization. After scaling root planing, the clinical parameters including PES, gingival recession, gingival thickness, postoperative pain and swelling as well as radiographic parameter obtained from Cone Beam Computed Tomography (CBCT) (buccal bone thickness) will be recorded. Immediate implant placement will be performed followed by simultaneous temporization in group A only. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Monthly follow-up will be performed to ensure performing proper oral hygiene. Data will be recorded at baseline (at time of implant insertion), three months, six months and nine months post prosthetic placement. Data collected will be tabulated and statistically analysed.
详细描述
• Intervention:
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Calibration process: Before beginning the study, outcome assessment will be calibrated. Outcome assessment will be performed by Co-investigator-II and Principal investigator. The calibration process will be repeated until each investigator has substantial correlation as measured by Cohen's Kappa (k ≥ 0.6).
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Clinical examination and preoperative evaluation using Cone Beam Computed Tomography (CBCT) (Recruitment):
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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.
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Evaluation of the soft tissue biotype by trans-gingival piercing using a periodontal probe.
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Width of keratinized gingiva in millimeters (measured by a periodontal probe from the gingival margin to the mucogingival junction). It is measured at three areas (mesial, mid buccal and distal)
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A preoperative CBCT will be performed for all patients before enrollment as a standard procedure. Evaluation and recording of the periapical condition, crestal bone level, available buccal bone thickness (not less than one millimeter), bucco-palatal bone width, height and density. Suitable implant length and diameter will be determined as well.
Patients with all inclusion criteria will be offered to participate in the study and sign a consent form. 3. Random allocation: After consenting, each patient will be allocated in one of the two study groups randomly using random numbers generated by rand.org created and kept by a teaching assistant not participating in the study. Grouping will be as follows:
- Group A (test group): Immediate implants placed with simultaneous immediate temporization (Immediate Implants + Immediate Temporization).
- Group B (control group): Immediate implants only
- Allocation concealment: It will achieved using a sealed coded opaque envelopes containing treatment of the subject. They will be kept by the teaching assistant. The envelope will be handed to the principal investigator and opened just before performing the surgical procedure.
- Blinding: blinding of investigators, outcome assessors and participants cannot be achieved due to the presence of a temporary crown in test group immediately after implant placement while being absent in the control group.
- Surgical procedure:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have at least one unrestorable tooth in the upper esthetic zone (anterior teeth and premolars) that need to be extracted with sound neighboring teeth
- •Systemically free patients (American Society of Anesthesiologists I)
- •Patients aged from 18 to 65 years old
- •Buccal bone thickness should be at least 1mm assessed in CBCT
- •Sinus floor or nasal floor clearance from root apex at least 4 mm as assessed in CBCT
- •Good oral hygiene
- •Accepts nine months follow-up period (cooperative patients)
- •Patient accepts to provides an informed consent
排除标准
- •Patients with signs of acute infection related to the area of interest or any pathological lesions that affect healing
- •Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits such as bruxism
- •Pregnant and lactating females
结局指标
主要结局
change in Pink Esthetic Score (PES)
时间窗: at 3, 6, 9 months
This will be performed by outcome assessor. PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence. All other variables will be assessed by comparison to a reference tooth (contralateral tooth).
次要结局
- White Esthetic Score (WES)(at 9 months)
研究者
Shahinaz Elashiry
Associate Professor
Misr International University