Bovine Pericardium Membrane Versus Native Collagen Membrane in Conjunction With Sticky Bone Graft in Treatment of Class II Furcation Defects in Lower Molars: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical ( Horizontal clinical attachment level [HCAL] )
研究概览
简要总结
Materials and methods: Twenty five patients (n=25) were selected from the outpatient clinic of the department of oral medicine and periodontology at Mansoura university's faculty of dentistry, 5 patients (n=5) were excluded as they didn't meet the inclusion criteria or met one or more of the exclusion criteria.
The participants 20 patients exhibiting one buccal or lingual mandibular molar furcation defect were assigned into two treatment groups: group I (control group), group II (study group), 10 patients in each group.
Patients in group I will be treated with open flap debridement, native collagen membrane and bovine bone graft particles. Patients in group II will be treated with open flap debridement, bovine pericardium membrane and bovine bone graft particles.
Periodontal assessment (plaque index (PI), gingival index (GI), horizontal clinical attachment level (HCAL), vertical clinical attachment level (VCAL), gingival recession (REC) and probing depth (PD)) will be evaluated at baseline, 3 months and 6 months after periodontal treatment.
Radiographic assessment using CBCT (bone loss in the horizontal direction (BL-H), bone loss in vertical direction (BL-V), length of the root trunk (RT), width of furcation entrance (FW) will be evaluated at baseline and 6 months after periodontal treatment.
详细描述
Study population:
The randomized controlled clinical trial includes 20 participants selected from the outpatient clinic of the department of oral medicine and periodontology at Mansoura university's faculty of dentistry from July 2024 to September 2024. All the patients exhibits one buccal or lingual mandibular molar furcation defect.
Study Design:
A double blinded, parallel group randomized controlled trial. The participants were randomly assigned using a computer random number generator program into two treatment groups:
- Group 1: The control group, includes 10 patients with class II furcation defects in lower molars and will be treated with open flap debridement, native collagen membrane and bovine bone graft particles.
- Group 2: The study group, includes 10 patients with class II furcation defects in lower molars and will be treated with open flap debridement, bovine pericardium membrane and bovine bone graft particles.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Display a buccal or lingual class II furcation defect (Hamp et al. classification) in their lower molars.
- •The tooth with a horizontal clinical attachment level (HCAL) greater than 3mm and a probing depth (PD) greater than or equal to 6mm in the mid-buccal or mid-lingual sites.
- •Have not undergone any periodontal treatment in the past 6 months.
- •A plaque index score (PI) below 1 at surgery, assessed using the Ramfjord teeth.
排除标准
- •Patients with class I or class III furcation defects.
- •Systemic disease contraindicating periodontal surgery.
- •Taking any medication that may have an impact on their periodontal health within the last 6 months.
- •Being pregnant or lactating.
- •Teeth with periapical lesions and teeth with mobility.
- •Third molars or teeth with improper endodontic or restorative treatment.
- •Patients with furcation caries, metal crowns in the furcation area or amalgam fillings near the alveolar crest.
研究组 & 干预措施
Control group
Are treated with open flap debridement, native collagen membrane and bovine bone graft particles.
干预措施: Native collagen membrane and bovine bone graft in treatment of class II furcation defects in lower molars (Procedure)
Study group
Are treated with open flap debridement, bovine pericardium membrane and bovine bone graft particles.
干预措施: Bovine pericardium membrane and bovine bone graft in treatment of class II furcation defects in lower molars (Procedure)
结局指标
主要结局
Clinical ( Horizontal clinical attachment level [HCAL] )
时间窗: 6 months
Is measured with Naber's probe, measure the depth of Furcation.
Radiographic ( Bone loss in the horizontal direction [BL-H] )
时间窗: 6 months
Using the CBCT axial view to measure the distance between the outer root surface and the inter-radicular bone.
次要结局
未报告次要终点
研究者
Ibrahim Ahmed Zein Elabdin Ahmed
BDS, Principal Investigator, Oral Medicine, and Periodontology Department.
Mansoura University