COMPARATIVE EVALUATION OF CLINICAL AND RADIOGRAPHICAL SUCCESS IN MINERAL TRIOXIDE AGGREGATE, BIOCERAMIC AND NANOHYRDROXYAPATITE AS PULPOTOMY MEDICAMENT IN PRIMARY MOLARS - A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- All cause morbidity at 3 months. Success rate of pulpotomy at 3 months (defined as absence of clinical symptoms and radiographic signs of pathology).
研究概览
简要总结
This randomized controlled trial compared the clinical and radiographic success of three pulpotomy medicaments in primary molars: Mineral Trioxide Aggregate (MTA), Bioceramic Putty, and Nano-Hydroxyapatite (nHA). Personal, medical, and dental histories were collected from all participants. Preoperative diagnostic radiographs were taken using RVG. The pulpotomy procedure involved local anesthesia, rubber dam isolation, complete caries removal, and coronal pulp amputation under sterile conditions. Hemostasis was achieved with saline and a moistened cotton pellet. The assigned medicament was then applied over the radicular pulp: MTA for Group I, Bioceramic Putty for Group II, and nHA for Group III. A zinc oxide eugenol base was placed over the medicament, and the tooth was restored with a stainless steel crown. Follow-up evaluations were conducted at 1, 3, and 6 months to assess clinical and radiographic outcomes.
The study aims to explore viable alternatives to MTA, which is considered the gold standard. Bioceramic materials may offer advantages such as easier handling, quicker setting time, and cost-effectiveness. nHA, due to its bioactivity and regenerative potential, could provide a more biocompatible option. These alternatives could enhance the accessibility of pulpotomy treatment, especially in low-resource areas. The findings contribute to evidence-based pediatric endodontics and support the continued development of innovative dental biomaterials. Effective pulpotomy medicaments help in maintaining arch length, supporting proper eruption of permanent teeth, and minimizing the need for invasive treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary molars with deep caries lesion without spontaneous pain Vital carious pulp exposures that bleed upon entering the pulp chamber Tooth with at least two thirds of root length.
排除标准
- •Medically compromised patients and uncooperative patients.
- •Children whose parents who did not give the consent.
- •Teeth shows the signs and symptoms of abscess, fistula, sinus tract and mobility.
- •Periapical pathology and calcifications in the canal were excluded from the trial.
结局指标
主要结局
All cause morbidity at 3 months. Success rate of pulpotomy at 3 months (defined as absence of clinical symptoms and radiographic signs of pathology).
时间窗: at baseline, 1 month, 3 months and 6 month
次要结局
- All cause morbidity at 1, 3 and 6 months. Incidence of post-operative pain and patient satisfaction by Five point likert scale.(at baseline, 1 month, 3 months and 6 month)
研究者
ELANCHEZHIYAN P
Adhiparasakthi dental college and hospital