Efficacy of Mineral Trioxide Aggregate (MTA) Pulpotomy as an Adjunct to Coronectomy in High-Risk Mandibular Third Molar Impactions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Primary Outcomes:
研究概览
简要总结
The extraction of impacted mandibular third molars is a common oral surgical procedure, but deeply impacted teeth in close proximity to the inferior alveolar nerve (IAN) carry a significant risk of nerve injury, which may result in paresthesia, dysesthesia, or anesthesia. Coronectomy, a nerve-sparing alternative to complete extraction, reduces the risk of IAN injury but is associated with complications such as root migration and postoperative infection.
Mineral Trioxide Aggregate (MTA) pulpotomy is a vital pulp therapy technique with proven biocompatibility and regenerative potential. Its application to retained roots after coronectomy may help seal the pulp chamber, minimize bacterial contamination, reduce infection risk, and stabilize the remaining root structure.
This randomized controlled trial will evaluate the efficacy of MTA pulpotomy as an adjunct to coronectomy compared with coronectomy alone and complete extraction. A total of 54 patients with high-risk mandibular third molars, identified radiographically by Rood and Shehab’s criteria, will be randomly allocated into three groups: Group A (Coronectomy + MTA pulpotomy), Group B (Coronectomy only), and Group C (Complete extraction - Includes patients who insist on extraction of impacted mandibular third molars even after being informed of the potential risk of inferior alveolar nerve injury.)
The primary outcomes will include postoperative pain, swelling, and IAN injury. Secondary outcomes will assess healing, infection, root migration, and patient-reported satisfaction and quality of life. The study is expected to provide evidence for improved management strategies in high-risk third molar impactions, with the aim of reducing postoperative morbidity while preserving IAN integrity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 50 years, classified as ASA I according to the American Society of Anesthesiologists classification, with indications for extraction of impacted mandibular third molars due to dental caries, caries in adjoining mandibular second molar or history of recurrent pericoronitis or periodontal disease.
- •Radiographic markers on panoramic X-rays: Radiographic assessment revealed one or more high-risk indicators as defined by Rood and Shehab, including increased radiolucency at the root apex, root narrowing, or disruption of the radiopaque border of the inferior alveolar nerve canal (IANC), indicating close proximity to the inferior alveolar nerve.
- •Cone-Beam Computed Tomography (CBCT) confirmation demonstrated direct contact between the root and the mandibular canal, with the absence of intervening cortical bone.
排除标准
- •Exclusion Criteria:
- •Patients with systemic conditions (uncontrolled diabetes, bleeding disorders etc ) , history of radiotherapy contraindicating surgical procedures.
- •Infection or periapical pathology involving the Impacted third molar region.
- •Pre-existing IAN injury or neurological deficits.
- •Non-vital teeth, caries extending to the root, periapical infection and immature root apex.
- •Mobility of root during coronectomy.
- •Patients not willing to provide informed consent.
- •Patients with a history of tobacco use in any form, including smoking and smokeless tobacco (e.g., pan, gutka).
结局指标
主要结局
Primary Outcomes:
时间窗: Primary Outcomes: | 1. Postoperative Pain: Measured using the Visual Analog Scale (VAS) at 6, 12, 24, and 48 hours, comparing pain reduction and total analgesic consumption between the MTA pulpotomy and coronectomy groups. | 2. Postoperative Swelling: Assessed using facial measurements on Days 1, 3, and 7 post-surgery. Quantified using facial measurements (tragus-commissure and tragus-pogonion distance), comparing preoperative and postoperative values. | 3. Inferior Alveolar Nerve (IAN) Injury: Assessed clinically for signs of paresthesia or dysesthesia in the area of the IAN/ mental nerve distibution, evaluated during follow-up visits day 1 using von frey monofilament fibres.
1. Postoperative Pain: Measured using the Visual Analog Scale (VAS) at 6, 12, 24, and 48 hours, comparing pain reduction and total analgesic consumption between the MTA pulpotomy and coronectomy groups.
时间窗: Primary Outcomes: | 1. Postoperative Pain: Measured using the Visual Analog Scale (VAS) at 6, 12, 24, and 48 hours, comparing pain reduction and total analgesic consumption between the MTA pulpotomy and coronectomy groups. | 2. Postoperative Swelling: Assessed using facial measurements on Days 1, 3, and 7 post-surgery. Quantified using facial measurements (tragus-commissure and tragus-pogonion distance), comparing preoperative and postoperative values. | 3. Inferior Alveolar Nerve (IAN) Injury: Assessed clinically for signs of paresthesia or dysesthesia in the area of the IAN/ mental nerve distibution, evaluated during follow-up visits day 1 using von frey monofilament fibres.
2. Postoperative Swelling: Assessed using facial measurements on Days 1, 3, and 7 post-surgery. Quantified using facial measurements (tragus-commissure and tragus-pogonion distance), comparing preoperative and postoperative values.
时间窗: Primary Outcomes: | 1. Postoperative Pain: Measured using the Visual Analog Scale (VAS) at 6, 12, 24, and 48 hours, comparing pain reduction and total analgesic consumption between the MTA pulpotomy and coronectomy groups. | 2. Postoperative Swelling: Assessed using facial measurements on Days 1, 3, and 7 post-surgery. Quantified using facial measurements (tragus-commissure and tragus-pogonion distance), comparing preoperative and postoperative values. | 3. Inferior Alveolar Nerve (IAN) Injury: Assessed clinically for signs of paresthesia or dysesthesia in the area of the IAN/ mental nerve distibution, evaluated during follow-up visits day 1 using von frey monofilament fibres.
3. Inferior Alveolar Nerve (IAN) Injury: Assessed clinically for signs of paresthesia or dysesthesia in the area of the IAN/ mental nerve distibution, evaluated during follow-up visits day 1 and at 1 week using von frey monofilament fibres.
时间窗: Primary Outcomes: | 1. Postoperative Pain: Measured using the Visual Analog Scale (VAS) at 6, 12, 24, and 48 hours, comparing pain reduction and total analgesic consumption between the MTA pulpotomy and coronectomy groups. | 2. Postoperative Swelling: Assessed using facial measurements on Days 1, 3, and 7 post-surgery. Quantified using facial measurements (tragus-commissure and tragus-pogonion distance), comparing preoperative and postoperative values. | 3. Inferior Alveolar Nerve (IAN) Injury: Assessed clinically for signs of paresthesia or dysesthesia in the area of the IAN/ mental nerve distibution, evaluated during follow-up visits day 1 using von frey monofilament fibres.
次要结局
- 1. Healing and Infection: Assess secondary intention healing and the incidence of postoperative infection (pus).(2. Post-operative Root Migration: Changes in the position of the retained root relative to anatomical landmarks on follow-up radiographs (OPG or CBCT) at 3, 6, and 12 months.)
研究者
Vijay Yadav
All India Institute Of Medical Sciences (AIIMS)