Dental Caries Clinical Trial
Official title:
Difference of Cost-efficacy Between Atraumatic Restoration Treatment (ART) and Composite Resin Restorations in Primary Molars: A Randomized Clinical Trial
The aim of this randomized clinical trial study is to compare the longevity of Atraumatic Restorative Treatment (ART) using high viscosity GIC and Conventional Treatment using composite resin under rubber dam isolation and local anesthesia (CT) in primary molars. As secondary outcomes, cost-efficacy, self-reported discomfort and cooperation will also be tested. Children aging between 3 to 6 years old presenting at least one occlusal and/or occlusoproximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or CT (control group). The dental treatment will be performed at a dental care trailer located in a Public School in Barueri (São Paulo, Brazil). The unit of analysis for randomization will be the child. A number of 204 teeth presenting occlusal cavities and 240 teeth presenting occlusoproximal cavities were set after sample size calculation. The primary outcome will be the restorations' longevity, which will be assessed after 6, 12, 18 and 24 months by two evaluators through clinical examination according to Frencken et al. (1998) criteria for occlusal restorations and Roeleveld et al. (2006) criteria for occlusoproximal restorations. The time spent during the dental treatment and all materials used will be considered for estimating the cost-efficacy of each treatment. The individual's discomfort will be also measured after each dental procedure using the Facial Scale of Wong-Baker. Cooperation will be assessed by the operator using a 5-point scale.
Research setting
The study will be performed in a dental care trailer which simulated a regular dental office
and it is located inside a public school of the city Barueri (São Paulo, Brazil).
Sample size calculation
For sample size calculation, data regarding longevity of CT in occlusal and occlusoproximal
restorations after 2 years were extracted from the literature as 86% for occlusal and 60% for
occlusoproximal restorations. A difference of 15% and 20% between the longevity of CT and ART
was set as non-inferiority limit. Considering the level of significance as 5%, power as 80%
and adding 40% due to the study design (cluster per child), a number of 204 occlusal
restorations and 240 occlusoproximal restorations will be needed.
Randomization
The child will be the unit of randomization which means that all eligible teeth of a
participant will be treated according the same restorative approach. Randomization list will
be obtained using blocks of 4, 6 and 8 generated by software Sealed Envelope Ltd. Opaque,
sealed and sequentially numbered envelopes will be used for randomizing all participants
immediately before restorative treatments' beginning.
Allocation concealment
To assure allocation concealment, the participant will be randomized immediately before the
treatment. When two or more cavities is available, preventing the finalization of the
treatment in only one session, breach of allocation concealment will be signalized in the
participants' record.
Blinding
Due to differences between the techniques, it will be not possible to blind operators,
participants and evaluators.
Operators
All operators will be masters or PhD students from the Pediatric Dentistry Department,
Faculty of Dentistry, University of São Paulo, previously trained. All procedures will be
performed with the assistance of a dental student previously trained to manipulate all
restorative materials.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04127929 -
Investigation of Glass Carbomer Performance
|
N/A | |
Completed |
NCT04769882 -
Er:YAG Laser Effects on Microbial Population in Conservative Dentistry
|
N/A | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Active, not recruiting |
NCT04475679 -
Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy
|
N/A | |
Completed |
NCT05438381 -
Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars
|
N/A | |
Not yet recruiting |
NCT03037814 -
Clinical Performance of Restorative Materials in Primary Teeth
|
N/A | |
Active, not recruiting |
NCT05202665 -
Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion
|
N/A | |
Terminated |
NCT01147835 -
Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers
|
N/A | |
Not yet recruiting |
NCT04033263 -
Maintaining Oral Health With Bio-products
|
N/A | |
Enrolling by invitation |
NCT04438252 -
Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions
|
N/A | |
Not yet recruiting |
NCT03609034 -
Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
|
||
Completed |
NCT02912000 -
TEACH: Technology Evaluation to Address Child Health
|
N/A | |
Completed |
NCT02473107 -
Impact of Detecting Initial and Active Caries Lesions in Primary Teeth
|
N/A | |
Active, not recruiting |
NCT02537184 -
Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children
|
N/A | |
Completed |
NCT01950546 -
Nanosilver Fluoride to Prevent Dental Biofilms Growth
|
Phase 1 | |
Recruiting |
NCT02734420 -
Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial
|
Phase 1 | |
Completed |
NCT02020681 -
Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions
|
N/A | |
Completed |
NCT02234609 -
Effectiveness of Modified Class IV Atraumatic Restorative Treatment
|
N/A | |
Completed |
NCT02426619 -
Arresting Active Dental Caries in Preschool Children by Topical Fluorides
|
Phase 2/Phase 3 | |
Completed |
NCT01268605 -
Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial
|
Phase 3 |