A clinical trial to compare the effect of two treatment methods for restoring primary molar.
- Conditions
- Children between the age group of 4-8 years with asymptomatic bilateral primary molars with dental caries.Dental caries, unspecified,
- Registration Number
- CTRI/2023/03/050781
- Lead Sponsor
- DR. ADITYA S NAIK
- Brief Summary
**Need for the study:**
Dental caries, continues to be a dental public health issue. With a better understanding of its pathology, it is realized that dental caries should not be treated simply by excavation of carious tissues and studies show that topical application of silver diamine fluoride (SDF) solution is effective in arresting dental caries in young children.38% SDF (44,800 ppm of fluoride and 253,870 ppm of silver) is effective in inhibiting bacterial growth, enhancing remineralization, and arresting caries .
One significant limitation of SDF treatment is that it stains carious lesions black . Furthermore, SDF can only arrest progress of dental caries. The caries cavity is still present and unfilled, which compromises chewing ability and dental plaque control.
Atraumatic restorative treatment (ART) is a minimally invasive operative approach to manage cavitated dentine carious lesions. Soft carious tissues are removed by hand instruments and local anesthesia is seldom needed. The cavity is cleaned and filled with an adhesive dental material.
SDF can be used in conjunction with the ART which would help eradicate cariogenic bacteria whilst promoting remineralisation of the carious lesion.
However, as less comparative studies on SDF in conjunction with ART are available, this study will be undertaken to compare and evaluate the clinical success of ART restorations placed in untreated and SDF-treated dentine caries lesions.
**Research Question**: Does prior SDF application improve the success rate of ART restorations placed in primary teeth?
**Research Hypothesis**: Prior SDF application improves the success rate of ART restorations placed in primary teeth.
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|**Methodology**
The present in vivo study will be conducted in the Department of Pedodontics and Preventive Dentistry, Government Dental College and Research Institute, Bangalore. Children between the age group of 4-8 years, with cooperative behavior(Frankel Behavior Rating Scale-FBRS of 3 and 4) coming to the department with asymptomatic bilateral primary molars with dental caries without any unfavorable medical history will be selected for the study. Prior to the procedure, the possible discomfort, risks and benefits will be explained and informed consent will be obtained from the parents.
· The International Caries Detection and Assessment System II (ICDAS II)
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|CODE
FEATURES
|Code 1
Smooth tooth surfaces.
|Code 2
Distinct visual change in enamel.
|Code 3
Localized enamel breakdown because of caries with no visible dentin or underlying shadow.
|Code 4
Underlying dark shadow from dentin with or without localized enamel breakdown.
|Code 5
Distinct cavity with visible dentin.
|Code 6
Extensive distinct cavity with visible dentin.
· A split mouth design will be adopted where all patients will receive 38% SDF followed by ART Restoration - Group A (experimental group) and ART restorations - Group B(control group) on either side primary molar which will be randomly assigned.
The other dental procedures, if any, are required for the child, will be addressed simultaneously along with the study protocols.
Pre operative radiograph will be taken before the procedure.
**Group A** - In the first appointment, 38% SDF will be applied by the operator trained to perform the procedure.
· The tooth will be washed and dried. Rubber dam will be placed prior to SDF application to isolate the tooth, to prevent saliva contamination and to protect gingivae from contacting excessive solution.
· The Operator will dip micro-applicator brush in 38% SDF solution (*Kids*-*e*-*dental*, India) and the solution will be applied according to the manufacturer’s instruction .Using the microapplicator brush ,the carious tooth structure will be coated with the solution. The solution will be allowed to dry for 3 minutes. The excess solution will be cleaned using a cotton swab.
· The children will be instructed not to eat or drink for half an hour.
**Group B** – Carious cavity will be restored with the use of ART approach using high-strength chemical-cured hand-mixed GIC in the first visit itself .The restorative procedures will follow the guidelines of the ART approach , which are briefly described below:
- The operation site will be isolated by cotton rolls
- Adequate access to the cavity will be created, if necessary an enamel hatchet will be used to enlarge the opening of a small cavity.
- Excavators of different sizes will be used to remove soft carious tissues and to prepare the cavity for restoration.
- The cavity will be cleaned by water and then dried by cotton pellets.
- The cavity surface will be conditioned with dentin conditioner (GC Gold Label, Japan) for 10 s, then washed with water and dried by cotton pellets.
- The GIC (GC Gold label, Japan) will be mixed according to the manufacturer’s instructions;
- The restorative material will be placed and pressed into the cavity by the ‘finger technique’, matrix will be used when placing GIC into a cavity in proximal tooth surface;
- The excess GIC material will be removed;
- The contour and shape of the restoration will be modified as necessary and the occlusion will be checked;
- The finished restoration will be covered by a layer of petroleum jelly.
The children will be instructed not to eat or drink for half an hour.
The patient will be recalled after 2 weeks. In Group A, SDF treated cavity will be restored with the use of ART approach using GIC (GC Gold Label, Japan).
The restorative procedures will follow the guidelines of the ART approach, as described for Group B.
ART evaluation criteria is used for clinical evaluation of the restorations at baseline, 6 months and 12 months.
Radiograph will be taken after 12 months follow up.
Clinically the restorations will be evaluated based on following criteria using CPI Probe.
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|CODE
CRITERIA
DEFINITION
|0
Present ,satisfactory.
Successful
|1
Present ,slight defect in the cavity margin of less than 0.5 mm, no repair is needed
Successful
|2
Present, marginal defect deeper than 0.5mm
Failed
|3
Partially present , restoration and/or tooth breakdown.
Failed
|4
Not present; restoration missing
Failed
|5
Not present, other restorative treatment has been performed
Failed
|6
Not present, tooth has been extracted
Failed
|7
Pulpal involvement
Failed
|C
Caries present
Failed
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 46
- All healthy children aged between 4-8 years, of both sexes.
- Requiring restorations of bilateral primary molars.
- Asymptomatic primary molars with active caries.
- ICDAS II Score 5 Cooperative children with Frankel behavior rating scale (FBRS) score of 3 or 4 All participants agreeing to the written informed consent and willing for the same.
- Children who suffered from serious systemic disease/conditions Tooth with pulpal involvement/pathology as evident by clinical and radiographic examination.
- Caries lesions which were too small for hand instruments to prepare the cavity for a restoration.
- Primary molars near exfoliation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical success of modified ART with 38% SDF in comparison to ART. Clinical evaluation of the restorations at placement, 6 months and 12 months.
- Secondary Outcome Measures
Name Time Method Radiographic success and absence of secondary caries. Radiographic evaluation before placement and after 12 months
Trial Locations
- Locations (1)
Government Dental College and Research Institute
🇮🇳Bangalore, KARNATAKA, India
Government Dental College and Research Institute🇮🇳Bangalore, KARNATAKA, IndiaDr Aditya S NaikPrincipal investigator9113568836adityanaik81.an@gmail.com