1.
Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial.
Milgrom, P, Tut, O, Rothen, M, Mancl, L, Gallen, M, Tanzer, JM
BMJ open. 2017;(6):e017866
Abstract
INTRODUCTION Dental caries (tooth decay) is a common disease in which the products of sugar metabolism by certain bacteria that populate the tooth surface induce the development and progression of lesions (cavities). This is a phase II single-centre randomised, double-blind, active-controlled, parallel-group trial to assess the efficacy of a combination povidone iodine and sodium fluoride dental varnish to determine if it is superior to a varnish containing only sodium fluoride in the prevention of new caries lesions. The objective of this report is to describe the rationale and protocol for the trial. METHODS AND ANALYSIS The study site is Pohnpei State, Federated States of Micronesia. The study population is 284 children 48-84 months old. The primary outcome will be the surface-level primary molar caries increment (d2-3mfs/DMFS) at 2 years post baseline. The incremental dental caries at 1 year will also be compared between the two interventions. The secondary outcome is the Facial Image Scale after the initial treatment and after the fifth treatment at 1 year that gauges the child's response to the treatment. ETHICS AND DISSEMINATION The Western Institutional Review Board (designated IRB) and the Institutional Review Board of the College of Micronesia-FSM approved all study procedures. The US Food and Drug Administration (FDA) has issued IND 128835 covering this study. The study results will be published and submitted to the FDA in support of a new drug application. TRIALREGISTRATION NUMBER NCT03082196.
2.
A CAMBRA Model For High Caries Risk Indian Children: A Pragmatic Comprehensive Tailored Intervention.
Gauba, K, Goyal, A, Mittal, N
The Journal of clinical pediatric dentistry. 2016;(1):36-43
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Abstract
OBJECTIVE To evaluate a CAMBRA based therapeutic and preventive model for high caries risk children in a pediatric dentistry clinic set-up. STUDY DESIGN A total of 100 systemically healthy children aged 4-8 years with dmft/DMFT ≥ 5 and/or ≤ 20% magnitude of cariogram sector 'chance to avoid new cavities' were enrolled. The program comprised of following components i.e. caries risk assessment, customized preventive interventions (Motivational interviewing and counseling, oral prophylaxis, fluoride varnish, fissure sealants) and restorative procedures. The recall intervals were scheduled on the basis of caries risk i.e. every 1 month (≤ 40% chance to avoid new cavities) and 3 months (≥ 41% chance to avoid new cavities). The primary outcome measure was 'new carious lesions' at 12 months following achievement of 'termination levels' i.e. ≥ 41% magnitude of 'chance to avoid new cavities.' The secondary outcome measures were changes in cariogram parameters at termination and duration needed to achieve termination levels. RESULTS The program showed 97% success rate as 3/100 subjects developed new carious lesions at 12 months follow up. Highly significant (p<0.001) favorable shift was achieved in cariogram parameters at termination. Termination levels were achieved in 2.71 ± 4.854 months. CONCLUSIONS The present CAMBRA based program with customized intervention and recall schedules showed favorable results.
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A prospective clinical trial on the influence of a triamcinolone/demeclocycline and a calcium hydroxide based temporary cement on pain perception.
Willershausen, B, Willershausen, I, Ehlers, V, Azaripour, A, Briseño, B
Head & face medicine. 2012;:9
Abstract
INTRODUCTION The aim of this clinical trial was to compare the degree of short term post-operative irritation after application of a triamcinolone/demeclocycyline based or a calcium hydroxide based provisional cement. METHODS A total of 109 patients (55 female and 54 male; mean age: 51 ± 14 years) with primary or secondary dentinal caries were randomly assigned to the two treatment groups of this biomedical clinical trial (phase III). Selection criteria were good systemic health and treated teeth, which were vital and showed no symptoms of pulpitis. Up to three teeth were prepared for indirect metallic restorations, and the provisional restorations were cemented with a triamcinolone/demeclocycyline (Ledermix) or a calcium hydroxide (Provicol) based material. The intensity of post-operative pain experienced was documented according to the VAS (4, 12, 20, 24, and 82 h) and compared to VAS baseline. RESULTS A total of 159 teeth were treated (Ledermix: 83 teeth, Provicol: 76 teeth). The minor irritation of the teeth, experienced prior to treatment, was similar in both groups; however, 4 h after treatment this value was significantly higher in the Provicol group than in the Ledermix group (p < 0.005, t-test). After 12 h, the difference was no longer significant. The number of patients taking analgesics for post-treatment pain was higher in the Provicol group (n = 11/53) than in the Ledermix group (n = 3/56). CONCLUSIONS The patients had no long term post-operative pain experience in both groups. However, within the first hours after cementation the sensation of pain was considerably higher in the Provicol group than in the Ledermix group.