Clinical trial NCT05305586: Comparison of Two Types of Splints to Treat Dental Luxation Injuries
Official title: Comparison of Bulk-fill Flowable and Packable Composite in Splinting of Luxation Injuries: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Trauma
Splints
Keywords: Dental trauma
Splints
bulkfill composite
packable composite
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 88
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study model was a randomised control trial. The included patients were randomly allocated to either group by a lottery method.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention of splint
timeFrame: 2 weeks
measure: Adhesive point dimension
timeFrame: 2 weeks
measure: Tooth mobility
timeFrame: 2 weeks
measure: Time consumed to apply and remove the splint
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Arshad Hasan, BDS, FCPS
role: STUDY_DIRECTOR
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