Comparison of effect of Protooth and Mineral Trioxide Aggregate in Direct pulp capping of primary molars
- Conditions
- Dental caries.Dental caries
- Registration Number
- IRCT20100125003168N6
- Lead Sponsor
- Reasearch Vice-Chancellor- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
5-8 years old children
Having a pair of symmetric second primary molar teeth in one jaw having deep caries and vital pulp
Capable of being restored by amalgam filling
No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule
Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test
Complete physical and mental health with no confounding history of systemic disease and/or use of special local or systemic drugs; No allergic reactions recorded in patient history
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 pathologic root resorption
Lack of informed consent by the child patient’s parent
Abnormal bleeding at the site of pulp exposure (i.e. bleeding which lasts for more than 3 minutes)
No evidence of pulp exposure at the site of caries excavation in symmetric second primary molar teeth, which were conventionally restored with an amalgam filling and excluded from our study
Evidence of pulp exposure surrounded by carious dentin which is indicative of pulpal contamination
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dental pulp vitality after treatment. Timepoint: 6 &12 months. Method of measurement: Lack of any of clinical or radiographic signs or symptoms of treatment failure.
- Secondary Outcome Measures
Name Time Method Radiographic success. Timepoint: 6&12 months. Method of measurement: Presence of one or more of the following radiographic signs will be considered as failure of treatment: internal and/or external root resorption, periodontal space widening, inter-radicular radiolucency, and periapical lesions.;Clinical success. Timepoint: 6 &12 months. Method of measurement: Presence of one or more of the following clinical signs/symptoms will be considered as failure of treatment: spontaneous pain, swelling, pathologic mobility, tenderness to pressure, and presence of sinus tract, swelling, and sensitivity to percussion.