Comparison of Two Types of Splints to Treat Dental Luxation Injuries

September 7, 2023 updated by: Arshad Hasan, Dow University of Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of splint
Time Frame: 2 weeks

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
Time Frame: 2 weeks

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
Time Frame: 2 weeks

'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
Time Frame: 2 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Study Director: Arshad Hasan, BDS, FCPS, Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2019

Primary Completion (Actual)

April 20, 2020

Study Completion (Actual)

May 4, 2020

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUHS/BASR/2019/472

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Splints

Clinical Trials on Splint retained by Packable Composite

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe