| Purpose: The goal of this split-mouth, randomized, prospective clinical trial was to evaluate radiographically the effectiveness of resin infiltration as an adjunct to standard-of-care preventative measures (fluoride application, oral hygiene instruction, and diet counseling) compared to standard-of-care preventative measures alone in controlling the progression of non-adjacent, incipient, enamel proximal carious lesions (E1 and E2) in primary molars after six and 12 months of treatment. Materials and Methods: A total of 45 healthy children aged 5-8 years old who had been diagnosed radiographically by at least two trained and calibrated examiners to have at least two non-adjacent, incipient, enamel proximal carious lesions in primary molars (total of 90 lesions) were included in the study. The lesions were randomly allocated to either case or control group. Case group lesions were treated using resin infiltration followed by topical fluoride (5% NaF) application versus only topical fluoride (5% NaF) in the control group lesions. All subjects were given oral hygiene instruction, diet counseling and flossing instructions including the proximal areas at the baseline, at the six-month and 12-month follow-ups. Other recorded variables included: (1) Date of birth; (2) gender; (3) race; (4); dmft (decayed, missing, filled primary teeth due to caries) at the treatment day; (5) Caries risk assessment (CAT). To provide standardization, individual bite registration was taken during the initial baseline visit and used at the follow-up appointments. The radiographic evaluation was performed after six and 12 months by two blinded, trained and calibrated examiners using pair-wise reading to determine whether lesions had progressed or not. A p-value of < 0.05 was considered statistically significant. Results: After six months of treatment, one of the subjects failed to come to this appointment; thus only 44 lesion pairs could be compared radiographically. Lesions treated with resin infiltration showed less 5 (11.4%) progression than control group lesions 8 (18.2%), but the difference was not statistically significant (p=0.453). At the 12-month follow-up, six of the subjects (13.3%) failed to come and one subject (2.2%) was excluded due to the exfoliation of control group tooth. Thus, a total of 38 lesion pairs were evaluated radiographically. Six (15.8%) of the lesions treated with resin infiltration showed signs of progression radiographically compared to 13 (34.2%) of the control group lesions; the difference was not statistically significant (p=0.092). Conclusion: Resin infiltration as an adjunct to standard-of-care preventative measures (fluoride application, oral hygiene instruction, and diet counseling) was not significantly different from the standard-of-care preventative measures alone in terms of radiographic progression of non-adjacent, incipient, enamel proximal carious lesions in primary molars when evaluated at six and 12 months after treatment. |
