methods of caries removal - A multicenter study

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-7jy2f7
• Date of registration: 24/10/2016
• Prospective Registration: No
• Primary sponsor: Universidade Federal do Rio Grande do Sul
• Public title: methods of caries removal - A multicenter study
• Scientific title: partial versus complete removal of decayed tissue - a multicenter controlled randomized clinical trial
• Date of first enrolment: 01/10/2014
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-7jy2f7
• Study type: Intervention
• Study design: clinical trial treatment, parallel, double-blind, randomized controlled trial with two arms
• Phase: N/A

Countries of recruitment

Brazil, Chile, Ecuador, Peru

Contacts

• Name: Joanna Pereira
• Affiliation: Universidade Federal do Rio Grande do Sul

• Name: Joanna Pereira
• Affiliation: Universidade Federal do Rio Grande do Sul

Key inclusion & exclusion criteria

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;
Exclusion criteria: patients suffering from bruxism; dental erosion; fluorosis and severe hypoplasia; patients with motor problems;

Age minimum: 4Y
Age maximum: 8Y
Gender: -

Health Condition(s) or Problem(s) studied

C07.793.720.210

Dental Caries

Intervention(s)

E06.323.528

Procedure/surgery

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.

Primary Outcome(s)

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(s)

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.

Source(s) of Monetary Support

Universidade Peruana Cayetano Heredia

Universidade Federal do Maranhão

Universidade do Chile

Universidade Internacional do Equador

Universidade Estadual de São Paulo

Universidade Federal do Rio Grande do Sul

Universidade da República do Uruguai

Universidade de São Paulo

Universidade Federal de Santa Maria

Secondary Sponsor(s)

Universidade Peruana Cayetano Heredia

Universidade da República do Uruguai

Universidade Federal do Maranhão

Universidade Internacional do Equador

Universidade de São Paulo

Universidade do Chile

Universidade Estadual de São Paulo

Universidade Federal de Santa Maria