Clinical study of two root filling materials in treating a vital pulp of deciduous tooth

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2022
INTERVENTION: E06.397.633 J01.637.051.339.859 This is a double‐blind, randomized controlled clinical trial. A total of 40 lower deciduous molars of children will be selected according to the eligibility criteria, the selection of the filling paste that will be used to perform the biopulpectomies will be randomly selected. The child and their guardians will not know which material was being used, as well as the evaluator in the clinical and radiographic follow‐ups. Experimental group: 20 primary teeth that will undergo biopulpectomy, and restoration with glass ionomer in a single session, using calcium hydroxide filling paste and polyethylene glycol 400 thickened with zinc oxide. Control group: 20 primary teeth that will undergo biopulpectomy, and restoration with glass ionomer in a single session, using the Filling Paste: Calcium Hydroxide Paste and iodoform. CONDITION: Pulpits; Periapical abscess with sinus PRIMARY OUTCOME: Expected outcome 1: The treated deciduous teeth were evaluated during a period of 3, 6 and 9 months, verified through the clinical and radiographic method. periapical lesion and presence of intact periodontal ligament, considering 5% of significance, power of 80% and correlation of 0.5 for the three times evaluated. Expected Outcome 3: It was also evaluated the condition of the filling material and the conditions and type of the definitive restorations during a period of 3, 6 and 9 months, verified through clinical success, from the observation of integrity and marginal discoloration, its anatomical shape , surface roughness and secondary caries, considering 5% significance, 80% power and 0.5 correlation for the three times evaluated. Expected outcome1: The deciduous teeth treated were methods during a period of 3, 6 and 9 months, selected through clinical and radiographic findings, the finding were considered clinical success, with no pain, no sensitivity to percussion, no abscess/ fistula absence of pathological mobility, considering 5% of significance of power of 80% and of continuity of 0.5 for the times of knowledge.; SECONDARY OUTCOME: Outcome 2: The percentage of success and radiography was 78.9% Calcium Hydroxide Paste and polyethylene glycol 400 thickened with zinc oxide for the and 81.0% Calcium Hydroxide Paste and iodoform. Outcome 3: The restorations presented satisfactory clinical behavior, in 72.5% of the cases, only 27.5% of the sample had failures in the restorations and without the occurrence of secondary caries. Outcome Found 1: Clinical success rate was 100% of the Zinc Oxide‐thickened Calcium Hydroxide Paste and Polyethylene Glycol 400 Paste as with Calcium Hydroxide Paste. INCLUSION CRITERIA: First or second deciduous lower molar with deep caries and pulp vitality; provoked or spontaneous pain that does not relieve with the use of medication; in case of teeth with provoked pain, absence of hemostasis in adequate time up to 5 minutes, after attempted pulpotomy; absence of fistula or abscess; absence of bone rarefaction on radiographic examination; absence of internal or external resorption of more than two thirds of the root; tooth restorative possibility
Epistemonikos ID: be6baa1237aa6d7279a114c32aa4df435109b967
First added on: Jul 31, 2024