Dental Caries in Children Clinical Trial
Official title:
Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement as a Preventative Intervention: A Split Mouth Study
The purpose of this study is to evaluate the efficacy of using orthodontic bands with glass ionomer cement to arrest or reverse interproximal lesions as a preventive treatment compared to monitoring and oral hygiene. The investigators hypothesize that placing orthodontic bands with glass ionomer cement will arrest and possibly remineralize incipient carious lesions compared to teeth that are being monitored without intervention.
This study is designed to determine the efficacy of orthodontic bands and glass ionomer cement in arresting and remineralizing incipient carious lesions as compared to monitoring for changes. This is a single blinded, split mouth randomized control trial, with the patient being their own control. A split mouth study is considered the gold standard because both experimental and control groups are exposed to the same environmet and conditions within the mouth. This study design eliminates confounding variables that may occur that could significantly alter the interpretation of end results (e.g. oral hygiene effectiveness between two patients). Participants will be screened at their routine periodic dental examination, where they will receive a dental exam, prophylaxis (cleaning), radiographs and fluoride varnish application in accordance with the guidelines from the American Academy of Pediatric Dentistry. Radiographs will be examined by an evaluator to determine if participants meet the inclusion criteria. Each participant requires at least one pair of permanent posterior teeth with interproximal caries lesions in enamel or in proximity of the dentinal enamel junction (E1, E2, early D1). An ideal pair consists of the same tooth type on the left and right side of the mouth (i.e. tooth #5 and #12, maxillary right permanent first premolar and maxillary left permanent first premolar). Another acceptable type of pair is same tooth type (i.e. tooth #5 and #21, maxillary right permanent first premolar and mandibular left permanent first premolar) or two adjacent teeth (i.e tooth #19 and 18 mandibular left first and second molar). Additionally, patients may also be screened when coming in for other dental treatment as well. Each participant will have his or her qualifying lesions randomized equally into two groups, one that will receive the band, and one that will not. Envelopes will contain the treatment conditions: Left/Upper/Distal or Right/Lower/Mesial, to indicate that the lesion on either the left/upper/distal or right/lower/mesial side of the mouth will get banded. They will be randomly organized and then ordered in the box. After randomization has occurred, each participant will have a blank orthodontic band (Denovo) fitted on the treatment lesion and cemented with glass ionomer cement (Fuji). Additionally, oral hygiene instructions will be reinforced. Participants will be instructed to return for their routine periodic dental exam in 6 months. Because the intervention is obvious, blinding the patient or the operator is not possible. At the 6 month visit, the band will be removed with a band remover prior to their dental exam and cleaning. Routine radiographs (according to the AAPD's radiographic guidelines) will be taken after the band has been removed. 20,21,22 A blinded second investigator will examine the pre and post treatment radiographs. Lesions will be classified initially by ADA CCS, and change will be noted as: progression, arrest, or regression. A de-identified data sheet containing the data will be sent to a statistician and a McNemar's Chi-square test will be used to test the differences in the lesion status of both groups ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03637309 -
Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
|
N/A | |
Completed |
NCT05531435 -
Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients
|
N/A | |
Not yet recruiting |
NCT05529433 -
Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars
|
N/A | |
Completed |
NCT03063307 -
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
|
N/A | |
Recruiting |
NCT05512156 -
Toothbrushing Program in Saudi Arabia "TOPS"
|
N/A | |
Not yet recruiting |
NCT06081868 -
RCT on Effectiveness of Oral Health Preventive Programmes in School Children in Uganda
|
N/A | |
Recruiting |
NCT06011005 -
Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel.
|
N/A | |
Completed |
NCT05645029 -
Evaluation of Glass Ionomer Cement Modified With Chlorhexidine and Titanium Dioxide in Primary Molars (RCT)
|
N/A | |
Recruiting |
NCT04195386 -
Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth
|
N/A | |
Recruiting |
NCT04195022 -
Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth
|
N/A | |
Completed |
NCT03480516 -
Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children
|
N/A | |
Completed |
NCT03311438 -
Oral Health Intervention Program for Children With Congenital Heart Defects
|
N/A | |
Completed |
NCT05110534 -
Supportive Caries Preventive Programme in Children Undergoing Dental General Anaesthesia
|
N/A | |
Completed |
NCT05638217 -
Efficacy of the Use of Silver Diamine Fluoride and Sodium Fluoride Varnish for the Treatment of Caries in Children
|
||
Completed |
NCT02002728 -
Comparison of Early Caries Detection in Children Utilizing an Electrical Conductance Device and the Gold Standard of Visual-tactile Technique.
|
N/A | |
Active, not recruiting |
NCT05121584 -
Evaluation of Two Different Types of Zirconia Crowns Used in Carious Primary Anterior Teeth
|
N/A | |
Completed |
NCT04666597 -
Pandemic-adapted Caries Care Multicentre Single-group Interventional Study
|
||
Completed |
NCT05652231 -
Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children
|
||
Completed |
NCT06018584 -
Biostimulation After Tooth Extraction
|
N/A | |
Active, not recruiting |
NCT05902975 -
Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
|
N/A |