Comparative Evaluation of Clinical and Radiographic Outcomes between Biodentin and Human Amniotic Membrane in Pulpotomy of developing Mandibular Second Molars with Irreversible Pulpitis: A Randomised Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This randomized controlled clinical trial aims to comparatively evaluate the clinical and radiographic outcomes of Biodentin and Human Amniotic Membrane when used as pulpotomy agents in developing permanent mandibular second molars diagnosed with irreversible pulpitis.
Eligible participants will be randomly allocated into two parallel groups in a 1:1 ratio. In Group I, pulpotomy will be performed using Biodentin as the pulp dressing material. In Group II, Human Amniotic Membrane will be placed over the radicular pulp tissue. All procedures will be carried out under standardized clinical protocols.
Participants will be evaluated clinically and radiographically at baseline, 1 month, 3 months, and 6 months. The primary outcome will be clinical and radiographic success at 6 months, defined as absence of pain, swelling, sinus tract, tenderness on percussion, abnormal mobility, and absence of radiographic signs such as periapical or furcal radiolucency, root resorption, or periodontal ligament widening.
The study aims to determine whether Human Amniotic Membrane demonstrates comparable clinical and radiographic success to Biodentin in pulpotomy procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants will include healthy children aged 13–17 years (ASA I/II) with developing permanent second molars showing incomplete root formation and a vital pulp diagnosis suitable for pulpotomy.
- •Teeth must have restorable crowns, no radiographic evidence of periapical or furcal radiolucency, no internal/external resorption, and the radicular pulp must exhibit controlled bleeding within 5 minutes after coronal pulp removal.
- •Only teeth with adequate radiographic visibility and patients/guardians who provide informed consent and are willing to attend follow-up visits will be included.
排除标准
- •Teeth will be excluded if they show signs of necrosis, uncontrolled radicular bleeding, irreversible pulpitis with swelling or sinus tract, internal or external resorption, or established periapical pathology.
- •Patients with systemic diseases affecting healing (ASA III/IV), allergies to study materials, inability to return for follow-up, poor cooperation, recent antibiotic/steroid use that may confound outcomes, or teeth with previous pulpal procedures will be excluded.
- •Teeth deemed unrestorable or compromised due to trauma, periodontal disease, or insufficient coronal structure will also be excluded.
研究者
DR VARNA R
Govt Dental College, Kozhikode