methods of caries removal - A multicenter study

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2016
INTERVENTION: E06.323.528 Initially the patient will be subjected to visual clinical examination and radiographic examination. after, the patient will undergo local anesthesia (2% lidocaine with epinephrine) and absolute isolation of the operative field. Partial caries removal (test) or total removal of decayed tissue (control) with the use of low‐speed drills and dentin spoons. after, tooth restoration will be held in question. Removal of absolute isolation, finishing and polishing the restoration. Will be 32 participants per group, each with at least two teeth to be treated (a test group and a control). Participants must attend to the procedures and after every 06 months for clinical and radiographic evaluation for 24 months. Procedure/surgery CONDITION: A00‐B99 C07.793.720.210 Dental Caries ; C07.793.720.210 PRIMARY OUTCOME: Outcome: Condition pulp ‐ pulp vitality.; It will be assessed by clinical parameters (no fistula, swelling, spontaneous pain and pathologic mobility) and radiographic parameters (no thickening of periodontal ligament, furcal injury, apical or periapical and / or pathological root resorption).; The evaluation will occur in the immediate postoperative period, 06, 12, 18 and 24 months. SECONDARY OUTCOME: Outcome: Quality of restorative procedures. It will be evaluated by examining the survival of the restorations rate over 24 months. This evaluation will take place through FDI criterion. Scores 1, 2 and 3 shall be deemed successful and scores 4:05 as restorative failure. The evaluation will occur in the immediate postoperative period, 06, 12, 18 and 24 months. INCLUSION CRITERIA: Teeth with occlusal contact with the antagonist and proximal contact in cases of occlusal proximal restorations at baseline; active deep carious lesions in dentin limited occlusal and occlusal proximal surface of deciduous molars; lesion in the dentine deep to 1 mm separating the injury of the pulp and the pulp to the dentin amelo junction divided by 2 the lesion must be on the inner half of dentin; absence of clinical diagnosis of pulp exposure; absence of fistula; absence of swelling and mobility not compatible with root resorption; absence of clinical signs and symptoms of irreversible pulpitis; absence of radiolucency in the furcation or periapical region or spacing of the periodontal ligament; lack of internal or external root resorption pathological; 4 to 8 years old; both sexes; good general health; children whose parents read and signed the consent form;
Epistemonikos ID: d1ee9c695c3051edd19ecfc92e55cb88f381d7f6
First added on: Aug 24, 2024