NCT05305586

Comparison of Two Types of Splints to Treat Dental Luxation Injuries

Comparison of Bulk-fill Flowable and Packable Composite in Splinting of Luxation Injuries: A Randomised Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Dow University of Health Sciences · Academic / Other
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objectives of this randomized clinical trial (RCT) were: 1. To compare the efficiency of splinting by two composite materials in terms of retention of material 2. To compare adhesive point dimension between the two groups 3. To compare time taken to place and remove the splint 4. To assess the efficacy of bulkfill flowable in reducing mobility of luxated teeth.

Detailed description

A Randomized control trial of 6 month period was done. Patients with luxation injuries aged between 16- 50 years were asked to participate in the study after taking informed consent. They were then assigned to either group (Group 1: Packable Composite (PC), Group 2: Bulkfill Flowable) by lottery method. Periotest was used to check the mobility of teeth before the placement of splint. Splinting was performed with composite material according to group allocation. Time taken to place the splint was recorded. Frontal view images of splinted teeth were taken with DSLR and transferred to Adobe Photoshop Version 22.4.1 for windows to measure surface area of the restorative material in percentage to total tooth surface area. Post-operative instructions were given. After 2 weeks, Periotest readings were recorded, immediately after removal of splint. On both visits 3 readings per tooth were recorded. Time taken to remove the splint was also recorded. Additionally, the retention of splint was also observed. STATISTICAL ANALYSIS: SPSS version 26 for windows was used, the mean time taken to apply and remove the material and mobility before and after removal of splint was compared using the independent samples T test. Mann-Whitney test compared the percentage area of the material occupied. Fisher's Eaxct test evaluated the retention of splint material. Level of significance was kept at p ≤0.05.

Conditions

• Dental Trauma
• Splints

Interventions

Type	Name	Description
DEVICE	Splint retained by Bulk-fill flowable	Luxated teeth were splinted with bulk-fill flowable composite
DEVICE	Splint retained by Packable Composite	Luxated teeth were splinted with packable composite

Timeline

• Start date: 2019-07-09
• Primary completion: 2020-04-20
• Completion: 2020-05-04
• First posted: 2022-03-31
• Last updated: 2023-09-11

Locations

1 site across 1 country: Pakistan