Reconstructive Treatment of Combined Peri-implantitis-related Defects With or Without Collagen Membrane: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of treatment success (%)
研究概览
简要总结
The aim of this randomized clinical study is to assess the additional clinical benefit of incorporating a resorbable collagen membrane (CM) alongside a xenogeneic bone graft-specifically, deproteinized bovine bone mineral with 10% collagen (DBBM-C)-in the reconstructive surgical treatment of peri-implantitis involving combined (i.e., contained and non-contained) defect configurations.
Accordingly, the study addresses the following research questions:
- Does the adjunctive use of a CM in combination with DBBM-C improve treatment success compared to DBBM-C alone in the management of combined peri-implantitis-related defects?
- Does the combined use of a CM and DBBM-C lead to superior patient-reported outcomes (PROs) compared to the use of DBBM-C alone in the reconstructive treatment of such defects? A total of 60 patients who have been referred to the Gazi University Department of Periodontology will be randomly assigned to receive test (DBMM-C +CM) or control group (DBMM-C) treatments. Clinical parameters will be assessed at baseline (i.e., prior to surgery), and at the 6-, and 12-month post-operatively. Radiographic examinations will be carried out at baseline and 12 months post-operatively. Patient oral health related to the treatment procedures will be evaluated using a written questionnaire [Oral Health Impact Profile (OHIP-14)] prior to treatment and after 2 weeks, 1, and 12 months following surgical therapy. Regarding post-treatment pain and overall patient satisfaction with treatment modalities, responses will be scored on a visual analog scale (VAS, 100 mm).
详细描述
Reconstructive surgical therapy for peri-implantitis has shown improved clinical and radiographic outcomes, with favorable postoperative mucosal margin levels and superior radiographic bone fill compared to other treatment modalities. However, no specific biomaterial or application technique has yet been identified as clearly superior. In particular, the potential added value of combining a barrier membrane with a bone substitute, as opposed to using bone substitute alone, remains a subject of ongoing debate.
Recent studies have suggested that the adjunctive use of a barrier membrane does not necessarily enhance clinical or radiographic outcomes in peri-implantitis-associated intrabony defects. However, these studies often included heterogeneous defect morphologies, which may influence the regenerative potential and confound treatment outcomes.
Indeed, "contained" and "non-contained" defects may behave differently due to biological factors such as space maintenance, clot stability, and wound protection. his highlights the need to tailor biomaterial selection to the specific defect configuration. While current evidence suggests that barrier membranes may not provide additional benefit in fully contained defects, there is a lack of data regarding their effectiveness in combined defects that include both supracrestal and intrabony components, particularly those with partially contained 2- or 3-wall morphologies.
Therefore, the primary aim of this randomized clinical study is to evaluate the additional clinical benefit of incorporating a resorbable CM with DBMM-C in the reconstructive surgical treatment of peri-implantitis with combined defect morphology.
The secondary objective is to assess patient-reported outcomes (PROs) in both treatment groups.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Peri-implantitis defined as the presence of a peri-implant probing pocket depth (PPD) ≥6 mm with bleeding and/or suppuration on probing (BoP/SoP) and radiographic marginal bone loss (MBL) ≥3 mm.
- •Presence of combined defect configuration Class [Ib, Ic, Ie with horizontal components (i.e. Class II) (Schwarz et al., 2010)] with an intrabony compartment of ≥3 mm.
- •Presence of a minimum width of 2 mm of keratinized peri-implant mucosa on the buccal aspect of the implant.
- •Implants placed in proper position (inside the bony housing)
- •Having an implant-supported prosthesis that allows for adequate oral hygiene procedures and peri-implant probing.
排除标准
- •Full-mouth plaque score (FMPS) < 25%
- •Full-mouth bleeding score (FMBS) < 25%
- •Cigarette smoking < 10 cig./day,
- •Diagnosed with active periodontal disease,
- •Having acute or chronic medical conditions or undergoing medications, such as intravenous amino-bisphosphonates, immunosuppressive drugs, and chemotherapy, that could interfere with the treatment outcome,
- •Receiving antibiotic treatment in the previous 3 months.
研究组 & 干预措施
Test Group
Reconstructive surgical therapy of combined peri-implantitis defects using a resorbable collagen membrane and DBMM-C.
干预措施: DBMM-C plus Resorbable collagen membrane (Device)
Control group
Reconstructive surgical therapy of combined peri-implantitis defects using only DBMM-C.
干预措施: DBMM-C (Device)
结局指标
主要结局
Percentage of treatment success (%)
时间窗: 12 months after the surgical treatment
The absence of bleeding on probing (BOP) at more than one site, no suppuration, deepest PPD ≤5mm, and no further radiographic bone loss.
次要结局
- Percentage of bleeding on probing (BOP) (%)(12 months after the surgical treatment)
- Probing pocket depth (PPD)(12 months after the surgical treatment)
- Change in radiographic vertical defect depth(12 months after the surgical treatment)
- Patient morbidity - Postoperative pain(At baseline and after 2 weeks and 1 and 12 months following surgical treatment)
- Patient-reported satisfaction with the overall treatment(At baseline and after 2 weeks and 1 and 12 months following surgical treatment)
研究者
Sıla Çağrı İşler
Associate Professor
Gazi University