Comparison of Two Types of Splints to Treat Dental Luxation Injuries

Dow University of Health Sciences

Status: Completed

Conditions: Dental Trauma; Splints

Treatments: Device: Splint retained by Bulk-fill flowable; Device: Splint retained by Packable Composite

Study type: Interventional

Funder types: Other

Identifiers

NCT05305586

DUHS/BASR/2019/472

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Permanent dentition patients aged between 16-50 years
• Either gender
• Lateral and extrusive luxation injuries

Exclusion criteria

• Patients with following conditions were excluded
• Intrusion injuries
• Root fracture
• Dentoalveolar fracture.
• Patients with systemic diseases.
• Patients with periodontitis
• Para-Functional habits
• Non-consenting patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

Packable Composite

Active Comparator group

Description:

Packable composite material was selected for splinting of luxated teeth

Treatment:

Device: Splint retained by Packable Composite

Bulkfill composite

Active Comparator group

Description:

Bulkfill composite material was selected for the splinting of luxated teeth

Treatment:

Device: Splint retained by Bulk-fill flowable