A Split-mouth Trial Comparing Biodentine and Calcium Hydroxide in the Indirect Pulp Treatment on Primary Teeth
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 主要终点
- Pain. Binary variable (present/absent).
研究概览
简要总结
Objective: The study's main purpose is to evaluate and compare the clinical and radiographic outcomes of Biodentine and a light-activated calcium hydroxide based-liner (Ultra-Blend plus®) as indirect pulp treatment (IPT) liners, over the dentin-pulp complex of vital primary molars with carious lesions approaching the pulp. Study design: 80 four-to-eight year-old patients were enrolled from a Mexican University Pediatric Dentistry Clinic. A split-mouth design trial is being conducted in order to compare both IPT interventions on 160 bilateral primary teeth, without signs or symptoms of irreversibly inflamed or degenerative pulp tissue. Teeth were treated and restored with a preformed crown in a single session, and then closely followed-up for 1, 3, 6, 12, 18, and 24 months.
详细描述
A Split-mouth clinical trial was the design selected. Clinical Procedures: IPT procedures were carried out by three pediatric dentistry residents (E.K.C.G., R.A.V.V., and J.M.A.R.), previously trained in the clinical setting with a pilot sample of 10 similar child patients each. Study participants received local anesthesia and rubber dam isolation, which was disinfected, followed by the remove of the carious peripheral dentin with high speed tungsten-carbide bur # 3, and air-water spray. Then, the soft dentin layer was carefully removed with a sharply-edged sterilized hand excavator, based on tactile and visual standards, leaving only the hard dentin adjacent to the pulp ceiling. The cavity was thoroughly rinsed only with water and then dried with sterilized cotton pellets; no other special disinfection protocol was applied. The next step consisted in the placement of the correspondent liner over the remanent carious dentin layer, following the manufacturers' instructions, and according to the randomly assignment scheme previously described. In the case of the control group, the liner was cured undr 20 seconds of light exposure. All treated molar were restored with stainless steel preformed crowns (3M ESPE) cemented with glass ionomer (Ketac-Cem, 3M ESPE). One week later, the same procedure was repeated in the opposite tooth with the contrary IPT agent.
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
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one restorable first or second primary molar in each side of the mouth, affected by an occlusal cavitated active caries lesion in deep dentin.
- •Cooperative patients.
- •Participants were included in the trial after parental acceptance through a signed informed consent.
排除标准
- •Molars with mobility, spontaneous pain or fistula, and radiographic findings such as a carious lesion with no evidence of residual dentin over the pulp chamber or manifest pulp exposition.
- •Normally internal root resorption or physiological root resorption less than 1/
- •Presence of periradicular/furcal radiolucent lesions.
- •Occurrence of a carious pulp exposure and bleeding during the operative procedure.
研究组 & 干预措施
Biodentine
Biodentine (Septodont, Saint-Maur-des-Fosses, France) has been recently introduced and marketed as a bioactive dentin substitute. The Biodentine powder contains tricalcium silicate, dicalcium silicate and calcium oxide, while its liquid consists of calcium chloride and a carboxylate-based hydrosoluble polymer (water-reducing agent).
After local anesthesia and rubber dam isolation, carious peripheral dentin is eliminated with a high speed tungsten-carbide bur # 3, and air-water spray. Then, the cavity's floor soft dentin layer is carefully removed with a sharply-edged sterilized hand excavator, leaving only the hard dentin adjacent to the pulp ceiling. The cavity is thoroughly rinsed only with water and dried with sterilized cotton pellets. The next step consists in the preparation of Biodentine liner (a mix of powder and liquid), following the manufacturers' instructions, and its placement over the remanent carious dentin layer.
干预措施: Indirect Pulp Treatment with Bioactive Dentin Substitute (Procedure)
Ultra-Blend plus (Calcium hydroxide)
Ultra-Blend plus® (Ultradent Products Inc., South Jordan, UT, USA). This material is a light-activated calcium hydroxide based-liner. Calcium hydroxide has demonstrated to reduce and promote immediate deactivation of the residual microorganisms after IPT.
After local anesthesia and rubber dam isolation, carious peripheral dentin is eliminated with a high speed tungsten-carbide bur # 3, and air-water spray. Then, the cavity's floor soft dentin layer is carefully removed with a sharply-edged sterilized hand excavator, leaving only the hard dentin adjacent to the pulp ceiling. The cavity is thoroughly rinsed only with water and dried with sterilized cotton pellets. The next step consists in the placement of Ultra-Blend plus liner over the remanent carious dentin layer, using a dycal metallic applicator. Finally, the liner is cured through light exposure during 20 seconds .
干预措施: Indirect Pulp treatment with Calcium hydroxide (Procedure)
结局指标
主要结局
Pain. Binary variable (present/absent).
时间窗: 2 years
Pain is assessed through interrogatory. It is a binary variable (pain present or pain absent)
次要结局
- Abnormal tooth mobility. Binary variable (present/absent).(2 years)
- Periradicular lesions. Binary variable (present/absent).(2 years)
- Sensitivity to percussion. Binary variable (present/absent).(2 years)
- Soft tissues inflammation. Binary variable (present/absent).(2 years)
- Sensitivity to palpation. Binary variable (present/absent).(2 years)
研究者
José Arturo Garrocho Rangel
Professor/Lecturer
Universidad Autonoma de San Luis Potosí