Tissue Changes Following Connective Tissue Grafting and Two-stage Implant Placement. A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Mucosa thickness
研究概览
简要总结
Suitable subjects who were in need of implant placement were randomised between two groups; Group-A (NA=23) received crestal implant placement. In Group-B (NB=23) a CTG harvested from the palate was stabilised over the implant-neck. At the time of implant placement (T0), Groups were categorized as having thin mucosa ≤2.5mm at the surgical site, or thick mucosa >2.5mm. Mucosa thickness, width of keratinised tissue (WKT), crestal bone levels and bone thickness were determined at T0 and at the two-stage surgery (T1).
详细描述
Initially, 48 patients were recruited from new referrals to the Lab of Preventive Dentistry, Periodontology and Implant Biology, Aristotle University of Thessaloniki (AUTh) for surgical placement of at least one implant located in the upper/lower jaw in the anterior/posterior segment.
Study design An initial screening visit included full-mouth periodontal assessment, radiographic examination, fulfillment of inclusion/exclusion criteria and suitable patients (n=48) were randomised into either treatment Group; in the control Group (Group-A), a conventional surgical protocol was followed for implant placement, while in the test Group (Group-B) implants were placed in conjunction with an autologous CTG. Each Group was further categorized as having thin mucosa (≤2.5mm for Subgroups-AI/-BI) or thick mucosa (>2.5mm for Subgroups-AII/-BII) at the implantation site before implant placement (baseline=T0). Implants were exposed 3-4 months later (T1).
Surgical procedures A single implant system (Osseotite, Certain, parallel wall, Biomet 3i, Florida, USA; implants of 3.25/4.0 mm in diameter) was used in all cases. At T0, following local anaesthesia (lidocaine hydrochloride 2%, epinephrine 1:100000, Lignospan standard, Septodont, France), crestal incisions were performed and full-thickness flaps were raised for implant placement. Implants were placed at the level of the alveolar crest following the manufacturer's surgical guidelines and a two-stage protocol. Flaps were repositioned using absorbable sutures (polygalactic acid 5/0 sutures; PGA, medipac, Greece). In Group-B, a similar protocol was followed as in Group-A, with the exception that following implant placement a CTG was harvested from the palate, between the maxillary canine and the first molar (Liu & Weisgold, 2002) and was stabilised onto the lingual flap using a horizontal mattress suture. Standardised dimensions of the CTG (11×6×1.5mm) were sought to cover the implant's shoulder and extend 3-5 mm on the buccal and the lingual aspect of the alveolar ridge (Fig. 1). Scoring of the periosteum for coronal advancement of the flaps was mainly performed in Group-B (16 of 23 cases).
Post-operative care Post-operative pain and oedema were controlled by Ibuprofen, 600 mg. All participants were prescribed antibiotics (Amoxicillin, 500 mg per 8 hours for 5 days) and were instructed to rinse twice daily with chlorhexidine digluconate (0.12%) and to abstain from oral hygiene in the test area for one week. Any post-operative adverse events (i.e. swelling, suppuration, flap dehiscence, persistent pain) were recorded upon suture removal ten days after surgery.
Clinical assessments
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •above 18 years of age
- •no active periodontal disease (Plaque Index ≤15%, Gingival Index ≤20%, <20% of sites equal to or deeper than 5mm).
排除标准
- •medical conditions that contraindicated surgical implant placement,
- •medication that interfered with bone metabolism,
- •pregnancy or lactation,
- •inadequate dimensions of the alveolar ridge or grafted bone at the surgical site,
- •tooth extraction 3 months prior to the study.
研究组 & 干预措施
Conventional Implant placement
conventional implant placement following the manufacturer's instructions
干预措施: Implant placement (Other)
Implant and Connective tissue grafting
implant placement in combination with connective tissue grafting
干预措施: implant placement in combination with connective tissue grafting (Procedure)
结局指标
主要结局
Mucosa thickness
时间窗: implant placement to implant exposure
measured by bone sounding on the alveolar crest and at 2- and 4 mm apically, both on the buccal and the lingual aspects
次要结局
- radiographic Implant to Bone Crest (I-BC) distance(Implant placement to implant exposure)
- Width of keratinised mucosa(Implant placement to implant exposure)
- Implant to Bone Crest (I-BC) distance(Implant placement to implant exposure)
- Thickness of the buccal and lingual bone(Implant placement to implant exposure)
研究者
Danae A. Apatzidou
Assistant Professor
Aristotle University Of Thessaloniki
