Efficacy of Platelet-Rich Fibrin Combined With Xenograft in the Treatment of Mandibular Molar Furcation Involvements
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Horizontal Clinical Attachment Level (HCAL)
研究概览
简要总结
The purpose of this randomized controlled clinical trial is to compare the effectiveness of advanced platelet-rich fibrin (A-PRF+) combined with xenograft versus a collagen membrane combined with xenograft in the treatment of degree II furcation involvements in mandibular first molars. Adult patients with periodontitis will randomly receive either the A-PRF+ treatment or the collagen membrane treatment during periodontal flap surgery. The study will evaluate clinical periodontal healing, bone regeneration using 3D imaging (CBCT), patient comfort (pain levels and satisfaction), and changes in the TWEAK biomarker in gingival crevicular fluid over a 6-month period.
详细描述
Furcation involvements in molars pose a significant challenge in periodontal therapy. This study aims to evaluate a regenerative approach using advanced platelet-rich fibrin (A-PRF+) to enhance clinical and radiographic outcomes. The study includes adult patients with periodontitis who have a degree II furcation involvement (Hamp 1975) on a mandibular molar, with a probing pocket depth of ≥ 5mm after initial non-surgical therapy.
Eligible patients will be randomly allocated to one of two surgical interventions:
Test Group: Open flap debridement followed by the application of A-PRF+ mixed with a xenograft (Cerabone), covered by an A-PRF+ membrane.
Control Group: Open flap debridement followed by the application of a xenograft (Cerabone) covered by a resorbable collagen membrane (Guided Tissue Regeneration).
Clinical parameters including Plaque Index (PlI), Gingival Index (GI), Probing Pocket Depth (PPD), Gingival Recession (GR), Vertical Clinical Attachment Level (VCAL), and Horizontal Clinical Attachment Level (HCAL) will be recorded at baseline and 6 months post-surgery using customized acrylic stents.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Patients diagnosed with periodontitis who have completed non-surgical treatment: scaling and root planing
- •Patients attending a follow-up visit at least 5 weeks after non-surgical treatment, demonstrating compliance and good oral hygiene cooperation
- •Presence of a mandibular molar with a Degree II furcation involvement according to Hamp (1975), presenting a residual periodontal pocket at the buccal site (PPD ≥ 5mm) after non-surgical treatment, and showing radiolucency in the furcation area on CBCT imaging
- •Plaque Index (PlI) < 1 following non-surgical treatment
- •Width of keratinized gingiva ≥ 2mm
- •Teeth with furcation defects where gingival recession does not extend apically beyond the buccal furcation fornix (no supragingival furcation exposure)
- •Teeth without occlusal trauma, pulpal or periapical pathologies, and no combined periodontic-endodontic lesions
- •Degree II furcation involvement according to Hamp (1975) and Subclass A or B according to Tarnow and Fletcher (1984)
- •The defect is located apical to the interproximal alveolar bone crest on CBCT imaging
排除标准
- •Patients with systemic diseases affecting periodontal treatment outcomes, such as: diabetes mellitus, heart disease requiring anticoagulant therapy, blood disorders, immunodeficiency, etc
- •Pregnant or lactating patients
- •Patients who have used antibiotics or any other medications affecting periodontal treatment outcomes within the last 6 months
- •Patients who smoke tobacco.
- •Patients who have used aspirin or medications affecting blood coagulation within 2 weeks prior to the blood collection for PRF preparation
- •Patients with a history of allergy to local anesthetics
- •Defects associated with grade II tooth mobility that has not been splinted, or grade III tooth mobility according to Miller (2014)
研究组 & 干预措施
A-PRF+ and Xenograft
Open flap debridement followed by the application of A-PRF+ mixed with xenograft (Cerabone), covered by an A-PRF+ membrane
干预措施: A-PRF+ and Xenograft (Procedure)
Collagen Membrane and Xenograft
Open flap debridement followed by the application of xenograft (Cerabone) covered by a resorbable collagen membrane
干预措施: Collagen Membrane and Xenograft (Procedure)
结局指标
主要结局
Horizontal Clinical Attachment Level (HCAL)
时间窗: Baseline and 6 months post-surgery
HCAL is evaluated using a Nabers probe and a customized acrylic stent to measure the horizontal penetration from the buccal furcation entrance to the deepest point of the defect
Probing Pocket Depth (PPD)
时间窗: Baseline and 6 months post-surgery
PPD is measured using a UNC-15 periodontal probe and a customized acrylic stent to ensure measurement reproducibility. The measurement is recorded at the buccal aspect of the involved tooth
次要结局
- Plaque Index (PlI)(Baseline, 3 months, and 6 months post-surgery)
- Gingival Index (GI)(Baseline and 6 months post-surgery)
- Vertical Clinical Attachment Level (VCAL)(Baseline and 6 months post-surgery)
- Gingival Recession (GR)(Baseline, 3 months, and 6 months post-surgery)
- Radiographic Vertical Bone Level (VBL)(Baseline and 6 months post-surgery)
- Furcation Defect Volume(Baseline and 6 months post-surgery)
- New Bone Gray Level(Baseline and 6 months post-surgery)
- TWEAK Biomarker Concentration(Baseline, 1 month, and 3 months post-surgery)
- Post-operative Pain Perception(12 hours, 1 day, and 3 days post-surgery)
- Post-operative Painkiller Consumption(Up to 3 days post-surgery)
- Post-operative Patient Satisfaction(3 days and 7 days post-surgery)
研究者
Thanh Si Ho
Doctor of Dental Surgery
University of Medicine and Pharmacy at Ho Chi Minh City