Comparison of Two Types of Splints to Treat Dental Luxation Injuries

Dental Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305586
• Other study ID #: DUHS/BASR/2019/472
• Status: Completed
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: May 4, 2020

Study information

• Verified date: September 2023
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 4, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Trauma
• Splints

Intervention

Device:
• Splint retained by Bulk-fill flowable
Luxated teeth were splinted with bulk-fill flowable composite
• Splint retained by Packable Composite
Luxated teeth were splinted with packable composite

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

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* Note: There are 82 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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