TCTR20240723002
Not yet recruiting
Phase 2
Clinical outcomes of bioactive restorative materials in class Il restored primary molar: Randomized clinical trial
n/a0 sites65 target enrollmentJuly 23, 2024
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- dental caries, proximal caries in primary tooth
- Sponsor
- n/a
- Enrollment
- 65
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age range: Participants are between 4 and 8 years old.
- •Health Status: Children with an American Society of Anesthesiologists (ASA) score of I, indicating good health.
- •Behavioral Assessment: A minimum rating of 3 on the Frankl scale, suggesting the child is likely to be cooperative.
- •Dental Condition: Presence of two proximal caries in primary molars involved dentin with similar size and shape in contralateral teeth without signs of pulp necrosis, with proximal and occlusal contact. If the patient has cavity at adjacent proximal contact, the cavity must be restored with composite resin prior to the experiment, randomized by computed random number generator (0,1\)
- •Caries Evaluation: Class II cavities with an International Caries Detection and Assessment System (ICDAS) score 4\-5, indicating visible dentin in a distinct cavity. With RA2 \- RB4 ICCMS radiographic evaluation
- •Radiographic Criteria: The study includes teeth expected to naturally exfoliate in no less than two years, with radiolucency extending from proximal area to middle 1/3 of dentin or distinct loss of enamel surface from inner half of enamel to outer 1/3 of dentin (RA2 \- RB4 ICCMS radiographic evaluation)
- •Absence of Pain and Infection: No spontaneous pain, no signs of infection such as fistulae, abscesses, swelling, or pain upon percussion.
- •Caries Risk: Participants identified as having a high to extremely high risk of caries.
Exclusion Criteria
- •Systemic Health Conditions: Participants with systemic pathologies that could affect overall patient health are excluded.
- •Dental Anomalies: Any cases of teeth with developmental irregularities, including discoloration, atypical anatomy or shape, and excessive mobility, are not included.
- •Pulp Exposure: Teeth showing dental pulp exposure that necessitates either extraction or root canal treatment are also excluded from the study.
- •Dental Condition: Cavity extending above line angle after preparation or cavity at mesial of first primary molar (D)
Outcomes
Primary Outcomes
Not specified
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