Clinical and Radiographic Evaluation of Injectable Composite Versus Packable Composite in Restoring of Primary Molars

Overview

This randomized clinical trial aims to compare the clinical and radiographic performance of injectable composite versus packable composite in restoring cavitated primary molars in children aged 4 to 8 years. Study Purpose To determine whether injectable composite performs as well as packable composite in Class I and II restorations in primary molars clinically and radiographically.

This randomized clinical trial aims to compare the clinical and radiographic performance of injectable composite versus packable composite in restoring cavitated primary molars in children aged 4-8 years. Study Purpose To determine whether injectable composite performs as well packable composite in Class I and II restorations in primary molars. Study Design Type: Randomized clinical trial Sample: 64 primary molars (32 per group) Allocation: 1:1 using concealed envelopes Group I (Experimental group): Injectable composite (Beautifil Flow Plus X F00, Shofu, Japan) Group II (Control group): Packable composite (Beautifil II LS, Shofu, Japan) Follow-up: Clinical at 3, 6, 12 months Radiographic at 0, 6, 12 months Location: Pediatric Dentistry Clinic, Cairo University Outcome Measures Primary Outcome Clinical Performance (FDI Criteria): Functional: marginal adaptation, fracture, proximal contact, occlusion, wear Biological: caries at margins, hard tissue defects, sensitivity, pulp status Esthetic: texture, staining, color match Secondary Outcome Radiographic Performance: Presence/absence of voids Marginal integrity on bitewing radiographs Rationale Injectable composites may offer: Better cavity adaptation Easier handling Shorter chair time (important in pediatric dentistry) Packable composites offer: Higher strength and wear resistance The study investigates whether injectables can match or outperform packables clinically. Hypothesis Null hypothesis: There is no difference between injectable and packable composites in clinical and radiographic success. Intervention The principal investigator ES will carry out all treatment procedures, and the patients will be randomly assigned to any of them. For both groups: 1. Informed consent from participating children parents. 2. Baseline records photographs, percussion test, periapical radiograph and personal data collection (Appendix 1: Diagnostic chart). 3. Diagnostic chart with personal, medical and dental history will be filled (Appendix 1: Diagnostic chart). 4. Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of restorative material that will be used then writing the patient name and I.D. on it and will be opened after performing the cavity). 5. Clinical examination will be performed to assess the clinical inclusion criteria. 6. Preoperative and Postoperative photographs will be taken. 10 7. The radiographic examination will be performed by taking a periapical x-ray using (bitewing technique) to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. 8. Administration of local anesthesia at the side of the affected tooth. 9. Application of rubber dam for isolation, then caries removal procedure will be performed using a sterile round end bur in a high-speed hand piece and walls will be finished by a sterile fissure bur. 10. After cavity preparation, conditioning of the tooth will be done using phosphoric acid 35% for 30 seconds to enamel and 10 seconds for dentin then after rinsing the acid etch by water for 10 seconds bond will be applied to the tooth using bond brush then cured for 20 seconds. 11. The restorative material will be placed in the cavity and will be cured for 40 seconds. 12. The last step is to finish and polish the restoration material. 13. Clinical assessment will be done after each visit using FDI criteria to assess the clinical performance of each restoration in the three domains (biological, functional and aesthetics) and radiographic assessment will be done for 0, 6, and 12 months using preapical bitewing x-ray. Sample size calculation: Data will be analyzed using Medcalc software, version 22 for windows (MedCalc Software Ltd, Ostend, Belgium). Categorical data will be described as frequency and percentage. Intergroup comparisons between categorical variables will be performed using the chi square test, while intragroup comparisons within each intervention will be performed using Cochran's Q test followed by pairwise multiple comparisons. A p-value less than or equal to 0.05 will be considered statistically significant, and all tests will be two tailed. Statistical power of the study will be set at 80% with a 95% confidence level. The sample size was calculated based on a previous study by Inthihas et al in 2019, in which the success rate of proximal giomer restorations in primary molars was 94.1% after 12 months (17). By implementing a two tailed Z test for the difference between two independent proportions with an alpha level of 5% and a power of 80%. The minimum sample size needed was 28 per group in order to detect a difference of 30%. Sample size was increased by 15% to compensate for possible dropouts to reach 32 teeth per group. Sample size was performed using G\*Power version 3.1.9.2 for windows.

Conditions

Interventions

Eligibility

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Outcomes

Central Contacts