Comparison of Two Types of Splints to Treat Dental Luxation Injuries
NCT ID: NCT05305586
Last Updated: 2023-09-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
88 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-07-09
Study Completion Date
2020-05-04
Brief Summary
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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.
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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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.
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.
Conditions
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Dental Trauma
Splints
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The study model was a randomised control trial. The included patients were randomly allocated to either group by a lottery method.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
The participants were unaware of the group allocation. In addition, the outcome assessments were performed by a blinded investigator
Study Groups
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Packable Composite
Packable composite material was selected for splinting of luxated teeth
Group Type
ACTIVE_COMPARATOR
Splint retained by Packable Composite
Intervention Type
DEVICE
Luxated teeth were splinted with packable composite
Bulkfill composite
Bulkfill composite material was selected for the splinting of luxated teeth
Group Type
ACTIVE_COMPARATOR
Splint retained by Bulk-fill flowable
Intervention Type
DEVICE
Luxated teeth were splinted with bulk-fill flowable composite
Interventions
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Splint retained by Bulk-fill flowable
Luxated teeth were splinted with bulk-fill flowable composite
Intervention Type
DEVICE
Splint retained by Packable Composite
Luxated teeth were splinted with packable composite
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Permanent dentition patients aged between 16-50 years
* Either gender
* Lateral and extrusive luxation injuries
* 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
* Intrusion injuries
* Root fracture
* Dentoalveolar fracture.
* Patients with systemic diseases.
* Patients with periodontitis
* Para-Functional habits
* Non-consenting patients
Minimum Eligible Age
16 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Dow University of Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Arshad Hasan
Head of Department, Operative Dentistry, Dow Dental College
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Arshad Hasan, BDS, FCPS
Role: STUDY_DIRECTOR
Dow University of Health Sciences
Locations
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Dow University of Health Sciences
Karachi, Sindh, Pakistan
Site Status
Countries
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Pakistan
References
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Yildirim Oz G, Ataoglu H, Kir N, Karaman AI. An alternative method for splinting of traumatized teeth: case reports. Dent Traumatol. 2006 Dec;22(6):345-9. doi: 10.1111/j.1600-9657.2005.00364.x.
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Friskopp J, Blomlof L, Soder PO. Fiber glass splints. J Periodontol. 1979 Apr;50(4):193-6. doi: 10.1902/jop.1979.50.4.193.
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Qin M, Ge L, Bai R. Use of a removable splint in the treatment of subluxated, luxated and root fractured anterior permanent teeth in children. Dent Traumatol. 2002 Apr;18(2):81-5. doi: 10.1034/j.1600-9657.2002.180207.x.
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Traebert J, Bittencourt DD, Peres KG, Peres MA, de Lacerda JT, Marcenes W. Aetiology and rates of treatment of traumatic dental injuries among 12-year-old school children in a town in southern Brazil. Dent Traumatol. 2006 Aug;22(4):173-8. doi: 10.1111/j.1600-9657.2006.00359.x.
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Ebeleseder KA, Glockner K, Pertl C, Stadtler P. Splints made of wire and composite: an investigation of lateral tooth mobility in vivo. Endod Dent Traumatol. 1995 Dec;11(6):288-93. doi: 10.1111/j.1600-9657.1995.tb00506.x.
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Negri MR, Panzarini SR, Poi WR, Sonoda CK, Manfrin TM, Vendrame dos Santos CL. Use of a cyanoacrylate ester adhesive for splinting of replanted teeth. Dent Traumatol. 2008 Dec;24(6):695-7. doi: 10.1111/j.1600-9657.2008.00629.x.
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Sonnenschein SK, Ziegler P, Ciardo A, Ruetters M, Krisam J, Kim TS. The impact of splinting mobile mandibular incisors on Oral Health-Related Quality of Life-Preliminary observations from a randomized clinical trial. J Clin Periodontol. 2021 Jun;48(6):816-825. doi: 10.1111/jcpe.13454. Epub 2021 Mar 17.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DUHS/BASR/2019/472
Identifier Type: -
Identifier Source: org_study_id
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