A Novel Approach of Pinhole Regenerative Therapy (PRT) in Treating Stage III Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Composite Clinical Outcome
研究概览
简要总结
Pinhole Regenerative Therapy (PRT) following minimally invasive non-surgical periodontal therapy (MINST) in the treatment of intrabony defects associated with Stage III Grade B periodontitis. Eligible patients with 2- or 3-wall intrabony defects will be randomly allocated to the study groups. Clinical outcomes, including probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain, together with radiographic bone defect fill assessed by periapical radiographs and CBCT, will be evaluated over a 6-month follow-up period to determine the effectiveness of the proposed minimally invasive regenerative approacا
详细描述
Periodontal intrabony defects associated with Stage III periodontitis remain a major clinical challenge because conventional surgical approaches may require extensive flap reflection, which can compromise soft tissue support and increase patient morbidity. Minimally invasive periodontal therapy has been introduced to preserve soft tissues while maintaining favorable clinical outcomes.
This randomized controlled clinical trial is designed to evaluate the efficacy of a novel Pinhole Regenerative Therapy (PRT) in the treatment of intrabony periodontal defects. The proposed technique is based on minimally invasive non-surgical periodontal therapy (MINST) followed by a minimally invasive pinhole approach for defect degranulation and regenerative graft placement without flap elevation. The technique is intended to maximize preservation of the surrounding soft tissues while promoting periodontal regeneration.
Patients diagnosed with Stage III Grade B periodontitis presenting with 2- or 3-wall intrabony defects will be recruited from the outpatient clinics of the Department of Oral Medicine and Periodontology, Faculty of Dental Medicine, Al-Azhar University. Eligible participants will be randomly allocated to the study groups according to the study protocol.
The primary outcome is radiographic intrabony defect fill assessed using periapical radiographs and cone beam computed tomography (CBCT). Secondary outcomes include probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain. Clinical parameters will be recorded at baseline, 3 months, and 6 months, while radiographic evaluation will be performed at baseline and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking was used in this case series. All participants received the same intervention, and no blinding of participants or investigators was performed
入排标准
- 年龄范围
- 39 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 39-61 years.
- •Systemically healthy patients.
- •Diagnosed with Stage III periodontitis.
- •Presence of probing pocket depth (PPD) ≥ 6 mm.
- •Presence of clinical attachment loss (CAL) ≥ 4 mm.
- •Presence of at least one 2- or 3-wall interproximal intrabony defect with:
- •Defect depth ≥ 3 mm.
- •Angulation width ≥ 45°.
- •Each participant contributed one maxillary or mandibular single- or multi-rooted interproximal intrabony defect.
排除标准
- •Patients with any systemic condition contraindicating surgical intervention.
- •Pregnant or lactating females.
- •Alcoholic patients.
- •History of periodontal therapy within the previous 6 months.
- •History of antibiotic administration within the previous 6 months.
- •Patients with unacceptable oral hygiene after re-evaluation following Step 1 and Step 2 periodontal therapy.
- •Teeth with any degree of mobility.
研究组 & 干预措施
Sub-junctional Pinhole Technique (S-PHT)
Participants with Stage III periodontitis and intrabony defects received minimally invasive non-surgical periodontal therapy (MINST), followed 4 weeks later by sub-junctional pinhole technique (S-PHT), including minimally invasive defect degranulation and xenogenic bone graft placement through a facial pinhole without flap elevation
干预措施: Sub-junctional Pinhole Technique (S-PHT) (Procedure)
结局指标
主要结局
Composite Clinical Outcome
时间窗: 9 months
Composite outcome of pocket closure ≤4 mm, clinical attachment level ,gain ≥3 mm, and absence of bleeding on probing .
次要结局
- Operation Chair Time(During the Intervention)
- Probing Pocket Depth(Base line ( day one ), and at nine months)
- Clinical Attachment Level (CAL)(Base line ( day one ), and at nine months)
- Patient Satisfaction (Postoperative Pain)(Immediately after surgery, Day 1, Day 2, and Day 3)
研究者
mahmoud eldestawy
Professor
Al-Azhar University