Comparison of Two Types of Splints to Treat Dental Luxation Injuries

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

Detailed Description
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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.

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

Conditions
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Dental Trauma, Splints

Intervention / Treatment
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* Device: Splint retained by Bulk-fill flowable
* Device: Splint retained by Packable Composite


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study model was a randomised control trial. The included patients were randomly allocated to either group by a lottery method.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Packable Composite<br>Packable composite material was selected for splinting of luxated teeth | Device: Splint retained by Packable Composite<br>* Luxated teeth were splinted with packable composite<br>|
| Active Comparator: Bulkfill composite<br>Bulkfill composite material was selected for the splinting of luxated teeth | Device: Splint retained by Bulk-fill flowable<br>* Luxated teeth were splinted with bulk-fill flowable composite<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of splint | Retention will be measured as follows: Fully bonded: No exposure of wire on composite material and wire remained bonded to tooth. Partially debonded: Specs of composite remained on wire and wire remained bonded to tooth. Unbonded: wire is exposed to oral cavity with no composite on it and wire is detatched from tooth and freely movable. The outcome will be measured as percentage of cases reporting with condition of interest in each group. | 2 weeks | 
| Adhesive point dimension | Percentage of area occupied by the material in comparison to the tooth will be noted as adhesive point dimension. The outcome will be measured as percentage occupied by the splinting material of total tooth area as it is visible from the front. In our case the wire splint is retained by either Bulkfill composite or Packable composite. Therefore, the percentage of area occupied by the splinting material is the outcome of interest. | 2 weeks | 
| Tooth mobility | 'Movement of tooth in its socket resulting from an applied force, usually measured on an increasing scale of 1-3, or measured by the amount of horizontal and/or vertical mobility in millimeters' The values of Periotest in assessment of tooth mobility is based on the scale given as: Grade 0: -0.8- +09 Grade I: +10- +19 Grade II: +20- +29 Grade III: +30- +50 The outcome will be measured as percentage of patients presenting with grade of tooth mobility before applying the splint and after removal of splint | 2 weeks | 
| Time consumed to apply and remove the splint | Application time: Amount of time taken in minutes from the beginning of splinting that is starting from applying the etchant till the last block of composite is cured. Removal time: The amount of time taken in minutes to remove the splinting material The outcome will be measured as amount time taken in mm:ss i.e. minute:second to apply and remove the splint in either group. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental trauma, Splints, bulkfill composite, packable composite