Clinical and Radiographic Evaluation of a New Bioactive Ionic Resin Material (ACTIVA™ BioACTIVE) Versus Compomer for Class II Restorations in Primary Molars: A Split Mouth Randomized Clinical Trial

EC UZG 2016/1050 - 1051

A clinical trial to evaluate a filling material (ACTIVA) and compare it to a traditional filling material (compomer) to restore decayed deciduous teeth in children

2017-01-01

2018-12-01

2018-12-01

Completed

Early phase I

35

Inclusion Criteria: * Healthy children with American Society of Anesthesiologists (ASA) I score from both gender aged between three and ten years * Vital decayed deciduous molar with proximal enamel/dentine caries * At least one decayed tooth on each side of the mouth (split mouth) * Pt is treatable in the dental chair * Parents agreed to participate in the study and signed the informed consent Exclusion Criteria: * Patients with medical conditions or systemic disease * Anxious or uncooperative patients who are not treatable in the dental chair * Any symptoms like: pain, swelling, abscess or fistula. * Extensive caries, dental developmental disturbance, pathological mobility, pulp exposure or indication for pulp therapy * Patients with one decayed tooth in the whole mouth (not split mouth)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Experimental prospective double blinded split-mouth randomized controlled trial .\n\nEach patient receive both types of treatment in the oral cavity, one type of the treatment on each side.\n\nThe patients act as their control', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "During treatment, the type of filling material was concealed from the patient, and the patient had no information which material was used in each side of the mouth. The type of material was not mentioned in the patient's file. Instead, it was replaced by a combination which the outcomes assessors were not familiar with. The operator was also blinded for the type of restoration during tooth preparation and was informed only at the time of restoration placement. The purpose of this discretion was to ensure double blinding both at the patient, as well as the outcomes assessor level.", 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 35, 'type': 'ACTUAL'}}

2023-11-22