UnknownNot Applicable

Comparison of Conventional Versus Conservative Caries Removal in Primary Teeth

49 participantsStarted 2017-01-15

Plain-language summary

The sample will be, at least, 90 primary molars, randomly distributed into three groups: Group 1: IPC; Group 2: SE; Group 3: SCR. Teeth must present deep caries lesions (at least 2/3 of dentin depth), pulp vitality (no clinical or radiographical signs of pulp disease, such as abcesses, fistulae, root resorption, abnormal tooth mobility). This study received approval by the Ethics Committee of Fluminense Federal University (UFF; Brazil) - # CAAE: 58812816.8.0000.5626. The study started in January, 2017; and will finish in December, 2020. Patients will be selected from the public schools in Nova Friburgo. The dental exams and treatment procedures will be done at the clinics from the School of Dentistry, Health Institute of Nova Friburgo (ISNF). Laboratory proceedings will be done at: * Clinical and Microbiological Research Laboratory (LAB PECMA - ISNF) - Sample storage, bacterial cultivation and identification. * University of North Carolina at Chapel Hill * Rio de Janeiro Federal University

Who can participate

Age range4 Years – 6 Years

SexALL

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Inclusion criteria

✓. The child need to be healthy;
✓. This should be in the age range of 4 to 6 years of age;
✓. The primary molars to be submitted to treatment should have the following characteristics: deep caries lesion (greater than or equal to 2/3 of dentine thickness) without clinical or radiographic aspects of pulp lesion, restoration margins above gingival line, absence of spontaneous pain or mobility, absence of periodontal changes, roots compatible with pulpal maturation stage.

Exclusion criteria

✕. Children under use of controlled drugs or antibiotics.
✕. Children who presented with some neurological or motor disorder that could influence the treatment procedure.
✕. Molars with more than three lost walls or margins in subgingival area.
✕. Patients with allergies to the medications used.
✕. Patients in the pulpal regression stage in which the tooth is likely to be lost within 12 months.

What they're measuring

Pulp vitality maintenance diagnosed by clinical exam

Timeframe: Through study completion, up to three years.

Pulp vitality maintenance diagnosed by radiograph exam

Timeframe: Through study completion, up to three years.

Trial details

NCT IDNCT03650647

SponsorUniversidade Federal Fluminense

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01-15

View on ClinicalTrials.gov More Dental Caries Extending Into Dentin trials