Clinical and Radiographic Evaluation of Potassium Nitrate in Polycarboxylate Versus Mineral Trioxide Aggregate in Vital Pulpotomy in Primary Molars: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical success rate
研究概览
简要总结
The purpose of this RCT is to compare the clinical/radiographic outcomes of Potassium nitrate in polycarboxylate cement and MTA as pulpotomy biomaterials used for asymptomatic vital primary lower second molar and this will help to clinically evaluate the use of alternative material in vital pulpotomy in primary molars with deep carious cavities.
Emphasis is set on avoiding total pupectomy and maintaining radicular pulp vitality therefore maintain the tooth in a viable condition till it's shedding and eruption of the permanent successor.
详细描述
Introduction:
Dental caries continues to be a significant health issue, with a very high prevalence in children worldwide. For a variety of reasons (lack of proper dental education, lack of access to dental care, "silent symptomatology," etc.), treatment is frequently initiated once the progression degree has reached a deep, cavitated stage, often with pulp involvement. The primary purpose of pulp therapy in deciduous dentition is to promote the health of the teeth and their supporting tissues in order to maintain the proper functions of the oro-facial complex (mastication, speech, aesthetics), and ultimately to retain the teeth in their position to preserve arch length. Primary teeth are referred to as "the best space maintainers" as they effectively preserve space for their successors.
Carious primary teeth with normal pulp or reversible pulpitis should be treated with vital pulp procedures. Currently, three vital pulp therapy (VPT) options exist for treating deep dentin caries lesions approximating the pulp in vital primary teeth: indirect pulp treatment (IPT), direct pulp cap (DPC), and pulpotomy.
VPT is primarily recommended to be performed in young patients because of the high healing capacity of pulp tissue compared to older patients. An adequate blood supply is required to maintain the pulp's vitality. Furthermore, the presence of a healthy periodontium is required for VPT to be effective, as teeth with moderate to severe periodontal disease are not candidates for treatment. In cases with an inadequate coronal seal and subsequent bacterial microleakage, the prognosis for VPT is significantly reduced.
Pulpotomy is a conservative clinical procedure performed on pediatric patients, and most recently on adult patients too, that involves the removal of the coronal pulp while preserving the radicular pulp. The rationale is based on the healing capacity of the remaining pulp tissue following surgical amputation of the affected or infected coronal pulp. Following hemostasis, the exposed pulp is covered with either a pulp-capping agent that promotes healing or an agent to fix the underlying tissue.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •❖ Inclusion Criteria:
- •Children aged 4 to 7 years, in good general health.
- •Children with vital, deeply carious primary molars.
- •No history of spontaneous pain, pathological mobility, draining sinus tract, redness or swelling of the vestibule.
- •Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
- •No sign of radiolucency in periapical or furcation area.
- •No widening of PDL space or loss of lamina dura continuity.
- •No evidence of internal/external pathological root resorption.
排除标准
- •Children with a physical disability or medical disability.
- •Unrestorable molars.
- •Uncooperative patient.
- •Parent unable to attend Follow- up visits.
- •Parents refuse to give written informed consent.
- •If the access was opened and irreversible pulpitis was evident.
研究组 & 干预措施
Group 1 (Potassium Nitrate in Polycarboxylate cement)
Potassium nitrate (KNO3) is a superior desensitizer for hypersensitive teeth. Used with polycarboxylate cement, it serves as an effective liner for deep carious lesions. Also when placed under deep restorations with less than 1 mm of protective dentin remaining, it was effective in preserving pulpal vitality and it diminished the incidence and severity of post-restoration pain. As temporary cement (Kno3/zinc oxide eugenol [ZOE]) It reduced pain following full crown preparation.
干预措施: Potassium Nitrate in Polycarboxylate cement (Combination Product)
Group 2 (Mineral Trioxide Aggregates "MTA")
Mineral trioxide aggregate (MTA) has been recommended as the gold standard for vital pulp therapy as it showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability
干预措施: MTA-Anglus (Other)
结局指标
主要结局
Clinical success rate
时间窗: Baseline, 1 week, 3 month, 6, 9 and 12 months after treatment
1. Post-operative pain: will be recorded by verbal question to patient/ parent. 2. Soft tissue pathology: will be recorded by visual clinical examination. 3. Pain to percussion: will be recorded by percussion test (by the back of the dental mirror). 4. Pathological mobility: will be recorded by mobility test (pressure using the end of two dental mirrors).
次要结局
- Radiographic success rate(Baseline, 3 month, 6 and 12 months after treatment)
研究者
Mariam Mahmoud Salah El-Mosallamy
Dentist
Cairo University
