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Completed

NCT Number: NCT05305586

Comparison of Two Types of Splints to Treat Dental Luxation Injuries

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.

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Key information

Conditions

Dental Trauma Splints

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University of Health Sciences

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Splint retained by Bulk-fill flowable

Device

Luxated teeth were splinted with bulk-fill flowable composite

Splint retained by Packable Composite

Device

Luxated teeth were splinted with packable composite

Primary outcomes

  1. 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. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2022
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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