ArticleBMC oral health2019
Impact of different restorative treatments for deep caries lesion in primary teeth (CEPECO 1) - study protocol for a noninferiority randomized clinical trial.
Article in BMC oral health, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02903979 (Impact of Different Restorative Treatments for Deep Caries Lesion in Primary Teeth), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Impact of Different Restorative Treatments for Deep Caries Lesion in Primary Teeth
Who cites it
0 citing papers in PubMed, 6 citations in OpenAlex.
No citing paper in PubMed yet.
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDue to the lack of evidence to determine the best treatment for deep cavitated caries lesions in primary molars, the search for an effective restorative technique, which results in a minimal discomfort to patients, and reduce the time needed for the treatment, becomes relevant. The objective of this randomized clinical trial was to evaluate if high-viscosity glass ionomer cement (HVGIC) restorations is noninferior to restoration with calcium hydroxide cement associated with HVGIC for treatment of deep lesions in primary molars, as well as the impact of the treatments on cost and discomfort of the patient.
methodsA non-inferiority randomized clinical trial with two parallels arms (1:1) will be conducted. Children with 4 to 8 years will be selected at Clinic of Pediatric Dentistry at Ibirapuera University. 108 teeth will be randomized into two groups: (1) Calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. Primary outcome will be considered the pulp vitality and to be evaluated after 6, 12, 18 and 24 months by two calibrated examiners. Survival of restorations will also be evaluated in the equal intervals. The duration of dentals treatment and the cost of all materials used will be considered for estimating of cost-efficacy of each treatment. Individual discomfort will be measured after each dental procedure using the Wong-Baker's Facial Scale. For the primary outcome, Kaplan-Meier survival and the long-rank test will be used to comparison between the groups. Cox regression will be performed to assess the influence of variables on the outcome. For all analyzes, the significance level is set at 5%. DISCUSSION: Based on the philosophy of ART, our hypothesis is that the HVGIC restoration is a possible approach to restore the deep caries lesion with pulp vitality without the use of rubber dam and anesthesia.
trial registrationClinicaltrials.gov registration NCT02903979 . Registered on June 9th 2016.
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