Title: Comparative evaluation of clinical outcome of different minimal invasive techniques in primary teeth: An invivo study Principal Investigator: JINNAPU POOJA Department: Pediatric and Preventive Dentistry Sibar Institute of Dental Sciences, Guntur INTRODUCTION Dental caries is an infectious microbiologic disease of the teeth that results in localized dissolution and destruction of the calcified dental tissue. It affects general health, having a negative impact on the quality of life, cognitive development, besides oral health and growth.1 A high number of untreated carious lesions presented in preschool children compared with other age-groups. Dental fear, economic confines, scheduling difficulties and conveyance issues are the obstacles to dental care for children. Conventionally in children, the management of the carious lesions through surgical removal of the carious tissue and the replacement with a suitable restorative material can be challenging for the young child.2So, Minimal invasive dentistry was developed to overcome these constraints, particularly in the pediatric age group and instill a positive dental attitude by permitting maximal preservation of sound dental tissue that has the capability of remineralization. Atraumatic restorative treatment has long been practiced in community-based set ups and was developed in Tanzania in the mid-1980s. It is based on the principle of removal of caries using sharp sterile hand instruments and then filling them with an adhesive restorative material.3 Chemomechanical caries removal on the other hand bears promising and a viable alternative which involves the use of a chemical product to soften the carious dentin or the degraded collagen followed by removal with gentle excavation. The first CM adjuncts were sodium hypochlorite-based, but subsequent products have alternatively emphasized the fruit-derived proteolytic enzyme papain Carie-fix which is one of the most recent papain-based CM adjuncts. In recent years there has also been interest in chemotherapeutic approaches to the arrest of dental caries, namely silver diamine fluoride in its most common 38% concentration which appears to the arrest the active dentinal caries lesions presumably through the synergistic action of silver and fluoride ions. A therapy combining ART with SDF pre-treatment – silver modified atraumatic restorative technique, is being employed by dentists.4 This novel approach brings together the capability of SDF to kill bacteria with that of GIC to seal the tooth and cut off nutrients needed for bacterial growth. Using SMART may not only arrest caries but also enhance better enamel remineralization while maintaining pulp vitality. ART is a well-established approach to managing frank cavitated carious lesions. CM adjuncts such as carie fix and CT therapies like SDF, may work in conjugation with ART. The aim of the study is to assess the clinical outcomes of ART, SMART, CMCR techniques in primary teeth.
Aim of the proposal: The aim of the study is to compare the clinical effectiveness of different minimal invasive techniques in primary teeth. Specific Objectives: To assess the clinical outcome of Atraumatic Restorative technique in primary teeth. To assess the Clinical outcome of Silver Modified Atraumatic Restorative technique in primary teeth To assess the clinical outcome of Chemomechanical Caries Removal and restorative technique in primary teeth. To compare and assess the above mentioned three different minimally invasive techniques in primary teeth. SUBJECTS & METHODS: Source of Data: The primary source of data includes clinical outcome of the treated teeth. Study design: Randomized clinical trial Study area: Department of Paediatric and Preventive Dentistry, Sibar Institute of Dental Sciences Study population: Children aged between 3-8 years attending the outpatient department of Pediatric and Preventive Dentistry Sampling technique: Nonprobability sampling Sample size: Sample size calculated was 66 Sample size derivation: Sample size will be determined by using G Power 3.1.9.4 software with an effect size of 0.4, alpha error probability is 5%, power 80%. Total sample size obtained was 66 and number of groups is 3 i.e., 22 in each group Duration: 1 year Inclusion criteria: ÂHealthy Children of age 3 to 8 years. ÂPrimary molars with caries lesions under code 5 according to international caries detection and assessment system Exclusion criteria: Children with any systemic conditions. Teeth with any signs and symptoms of pulpal pathology. Teeth with unrestorable crown structure. Methodology: A total of sixty-six primary molars in children without any gender discrimination of age 3-8 years, attending as out patients to the department of Paediatric and Preventive Dentistry, Sibar institute of Dental sciences, Guntur will be included to participate in the study. Prior to the treatment, the procedure will be explained to the parent and children and informed written consent will be obtained from the parent/guardian. Procedure: A total of 66 primary molars with cavitated carious lesions under ICDAS6 score 5 and confirmed using intra oral periapical radiographs using paralleling technique will be selected for the study and will be randomly divided into 3 groups of 22 in each group. Group I will be treated with ART, group II with SMART and group III with CMCR techniques. All the treatments will be done according to the standard protocols. In group l, the involved tooth will be isolated with cotton pellets, the entrance of the lesion will be widened by enamel hatchet to remove unsupported enamel rods and then caries will be removed using spoon excavator and restored using Glass Ionomer Cement Ketac molar. In group ll, the identified carious lesion of the affected tooth will be isolated and petroleum jelly will be applied to protect the adjacent teeth and mucosa. 38% Silver diamine fluoride Riva star will be applied directly to the lesion with a micro- brush and left for 1 min and the excess will be removed with cotton tip applicator. After dryness of SDF, the tooth will be restored with GIC Ketac molar The parents were instructed to prohibit the child from eating or drinking for 30 min after the application. In group III, the involved tooth will be isolated with cotton pellets and CMCR agent carie fix gel was applied to the carious lesion. After 60s, the treated area shows a cloudy appearance. Later on, the gel will be removed with a moistened cotton pellet and softened carious dentin will be scrapped off using spoon excavator. Caries removal will be verified by probing with explorer. The tooth will be then restored with glass ionomer cement according to the manufacturer instructions. After the procedure was completed, the high points were checked with articulating paper. After performing the different minimal invasive techniques in primary molars, the follow up examinations will be carried at 3 and 6 months intervals. The evaluation will be done based on criteria given by Francis et al8. Apart pain, mobility and clinical abscess will also be included to assess the status of the treated molars. The data thus obtained will be collected and subjected to statistical analysis to show the difference between groups. Potential risks and Benifits: No potential risks will be involved. Minimal invasive techniques are significantly less discomfort and distress and are considerably less expensive with increased patient acceptance. These techniques will hold an excellent promise in both clinical and community-based setting and instill a positive dental attitude by permitting maximal preservation of sound dental tissue that has the capability of remineralization. Statistical analysis: ÂFor intra group analysis of pain, mobility and abscess will be done using Chi square test and for integrity of restoration Wilcoxon Signed-Rank test will be used. Significance p < 0.05. ÂFor Inter group comparison One-way ANOVA test will be used Significance p < 0.05.
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