Dental TraumaNCT05305586
Comparison of Two Types of Splints to Treat Dental Luxation Injuries
A study testing Splint retained by Bulk-fill flowable and Splint retained by Packable Composite in people with Dental Trauma and Splints, run by Dow University of Health Sciences at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Trauma, Splints
- What is being tested?
- Splint retained by Bulk-fill flowable and Splint retained by Packable Composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Jul 2019to 4 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Permanent dentition patients aged between 16-50 years
- Either gender
- Lateral and extrusive luxation injuries
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- To compare the efficiency of splinting by two composite materials in terms of retention of material
- To compare adhesive point dimension between the two groups
- To compare time taken to place and remove the splint
- To assess the efficacy of bulkfill flowable in reducing mobility of luxated teeth.
Read the 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.
- Conditions
- Dental Trauma, Splints
- Being tested
- Splint retained by Bulk-fill flowable, Splint retained by Packable Composite
- Keywords
- Dental trauma, Splints, bulkfill composite, packable composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splint retained by Bulk-fill flowableDevice
Luxated teeth were splinted with bulk-fill flowable composite
Splint retained by Packable CompositeDevice
Luxated teeth were splinted with packable composite
| Study group | Role | What they receive |
|---|---|---|
| Packable Composite | Active comparator | Packable composite material was selected for splinting of luxated teeth Receives: Device: Splint retained by Packable Composite |
| Bulkfill composite | Active comparator | Bulkfill composite material was selected for the splinting of luxated teeth Receives: Device: Splint retained by Bulk-fill flowable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start9 Jul 2019
- Primary completion20 Apr 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (82)Papers the sponsor has linked to this study.
- Other trials for Dental TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study model was a randomised control trial. The included patients were randomly allocated to either group by a lottery method.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshad Hasan, Dow University of Health Sciences
- Investigators
- Arshad Hasan, BDS, FCPS, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305586
- Sponsor's protocol ID
- DUHS/BASR/2019/472
- Status last verified
- Sep 2023
- First submitted
- 4 Mar 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bratteberg M, Thelen DS, Klock KS, Bardsen A. Traumatic dental injuries-Prevalence and severity among 16-year-old pupils in western Norway. Dent Traumatol. 2018 Jun;34(3):144-150. doi: 10.1111/edt.12399.
PubMed 29569840Zhu Y, Chen H, Cen L, Wang J. Influence of abutment tooth position and adhesive point dimension on the rigidity of a dental trauma wire-composite splint. Dent Traumatol. 2016 Jun;32(3):225-30. doi: 10.1111/edt.12241. Epub 2015 Oct 28.
PubMed 26511774Da Silva AC, Passeri LA, Mazzonetto R, De Moraes M, Moreira RW. Incidence of dental trauma associated with facial trauma in Brazil: a 1-year evaluation. Dent Traumatol. 2004 Feb;20(1):6-11. doi: 10.1111/j.1600-4469.2004.00212.x.
PubMed 14998409Bourguignon C, Cohenca N, Lauridsen E, Flores MT, O'Connell AC, Day PF, Tsilingaridis G, Abbott PV, Fouad AF, Hicks L, Andreasen JO, Cehreli ZC, Harlamb S, Kahler B, Oginni A, Semper M, Levin L. International Association of Dental Traumatology guidelines for the management of traumatic dental injuries: 1. Fractures and luxations. Dent Traumatol. 2020 Aug;36(4):314-330. doi: 10.1111/edt.12578. Epub 2020 Jul 17.
PubMed 32475015Berthold C, Auer FJ, Potapov S, Petschelt A. Rigidity evaluation of quartz-fiber splints compared with wire-composite splints. Dent Traumatol. 2012 Feb;28(1):65-74. doi: 10.1111/j.1600-9657.2011.01031.x. Epub 2011 Jul 26.
PubMed 21790986Kaste LM, Gift HC, Bhat M, Swango PA. Prevalence of incisor trauma in persons 6-50 years of age: United States, 1988-1991. J Dent Res. 1996 Feb;75 Spec No:696-705. doi: 10.1177/002203459607502S09.
PubMed 8594093Khan NA, Qazi HS, Maxood A, Khan AM, Abbas I. Traumatic injuries of the permanent maxillory incisors at Dental Department, Pakistan Institute of Medical Sciences Islamabad: a retrospective study. J Ayub Med Coll Abbottabad. 2008 Jul-Sep;20(3):84-7.
PubMed 19610526Petti S, Andreasen JO, Glendor U, Andersson L. The fifth most prevalent disease is being neglected by public health organisations. Lancet Glob Health. 2018 Oct;6(10):e1070-e1071. doi: 10.1016/S2214-109X(18)30380-2. No abstract available.
PubMed 30223983Piovesan C, Abella C, Ardenghi TM. Child oral health-related quality of life and socioeconomic factors associated with traumatic dental injuries in schoolchildren. Oral Health Prev Dent. 2011;9(4):405-11.
PubMed 22238740Feliciano KM, de Franca Caldas A Jr. A systematic review of the diagnostic classifications of traumatic dental injuries. Dent Traumatol. 2006 Apr;22(2):71-6. doi: 10.1111/j.1600-9657.2006.00342.x.
PubMed 16499629Hermann NV, Lauridsen E, Ahrensburg SS, Gerds TA, Andreasen JO. Periodontal healing complications following extrusive and lateral luxation in the permanent dentition: a longitudinal cohort study. Dent Traumatol. 2012 Oct;28(5):394-402. doi: 10.1111/edt.12000. Epub 2012 Sep 12.
PubMed 22971023Spinas E, Pipi L, Dettori C. Extrusive Luxation Injuries in Young Patients: A Retrospective Study with 5-Year Follow-Up. Dent J (Basel). 2020 Dec 16;8(4):136. doi: 10.3390/dj8040136.
PubMed 33339132Nikoui M, Kenny DJ, Barrett EJ. Clinical outcomes for permanent incisor luxations in a pediatric population. III. Lateral luxations. Dent Traumatol. 2003 Oct;19(5):280-5. doi: 10.1034/j.1600-9657.2003.00209.x.
PubMed 14708653Ferrazzini Pozzi EC, von Arx T. Pulp and periodontal healing of laterally luxated permanent teeth: results after 4 years. Dent Traumatol. 2008 Dec;24(6):658-62. doi: 10.1111/j.1600-9657.2008.00687.x.
PubMed 19021659Flores MT, Andersson L, Andreasen JO, Bakland LK, Malmgren B, Barnett F, Bourguignon C, DiAngelis A, Hicks L, Sigurdsson A, Trope M, Tsukiboshi M, von Arx T; International Association of Dental Traumatology. Guidelines for the management of traumatic dental injuries. I. Fractures and luxations of permanent teeth. Dent Traumatol. 2007 Apr;23(2):66-71. doi: 10.1111/j.1600-9657.2007.00592.x.
PubMed 17367451
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bulk-fill Flowable and Packable Composite in Splinting of Luxation Injuries: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05305586
- Acronym / sponsor ID
- DUHS/BASR/2019/472
- Conditions
- Dental Trauma, Splints
- Keywords
- Dental trauma, Splints, bulkfill composite, packable composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this randomized clinical trial (RCT) were:
- To compare the efficiency of splinting by two composite materials in terms of retention of material
- To compare adhesive point dimension between the two groups
- To compare time taken to place and remove the splint
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study model was a randomised control trial. The included patients were randomly allocated to either group by a lottery method.
| Arm | Type | Receives |
|---|---|---|
| Packable Composite | Active comparator | Device: Splint retained by Packable CompositePackable composite material was selected for splinting of luxated teeth |
| Bulkfill composite | Active comparator | Device: Splint retained by Bulk-fill flowableBulkfill composite material was selected for the splinting of luxated teeth |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Permanent dentition patients aged between 16-50 years
- Either gender
- Lateral and extrusive luxation injuries
Key exclusion criteria (8 listed)
- Patients with following conditions were excluded
- Intrusion injuries
- Root fracture
- Dentoalveolar fracture.
- Patients with systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Splint retained by Bulk-fill flowableLuxated teeth were splinted with bulk-fill flowable composite | Device | Bulkfill composite |
| Splint retained by Packable CompositeLuxated teeth were splinted with packable composite | Device | Packable Composite |
Primary outcome
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.
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 29569840Bratteberg M, Thelen DS, Klock KS, Bardsen A. Traumatic dental injuries-Prevalence and severity among 16-year-old pupils in western Norway. Dent Traumatol. 2018 Jun;34(3):144-150. doi: 10.1111/edt.12399.
- Background: PubMed 26511774Zhu Y, Chen H, Cen L, Wang J. Influence of abutment tooth position and adhesive point dimension on the rigidity of a dental trauma wire-composite splint. Dent Traumatol. 2016 Jun;32(3):225-30. doi: 10.1111/edt.12241. Epub 2015 Oct 28.
- Background: PubMed 14998409Da Silva AC, Passeri LA, Mazzonetto R, De Moraes M, Moreira RW. Incidence of dental trauma associated with facial trauma in Brazil: a 1-year evaluation. Dent Traumatol. 2004 Feb;20(1):6-11. doi: 10.1111/j.1600-4469.2004.00212.x.
- Background: PubMed 32475015Bourguignon C, Cohenca N, Lauridsen E, Flores MT, O'Connell AC, Day PF, Tsilingaridis G, Abbott PV, Fouad AF, Hicks L, Andreasen JO, Cehreli ZC, Harlamb S, Kahler B, Oginni A, Semper M, Levin L. International Association of Dental Traumatology guidelines for the management of traumatic dental injuries: 1. Fractures and luxations. Dent Traumatol. 2020 Aug;36(4):314-330. doi: 10.1111/edt.12578. Epub 2020 Jul 17.
- Background: PubMed 21790986Berthold C, Auer FJ, Potapov S, Petschelt A. Rigidity evaluation of quartz-fiber splints compared with wire-composite splints. Dent Traumatol. 2012 Feb;28(1):65-74. doi: 10.1111/j.1600-9657.2011.01031.x. Epub 2011 Jul 26.
- Background: PubMed 8594093Kaste LM, Gift HC, Bhat M, Swango PA. Prevalence of incisor trauma in persons 6-50 years of age: United States, 1988-1991. J Dent Res. 1996 Feb;75 Spec No:696-705. doi: 10.1177/002203459607502S09.
- Background: PubMed 19610526Khan NA, Qazi HS, Maxood A, Khan AM, Abbas I. Traumatic injuries of the permanent maxillory incisors at Dental Department, Pakistan Institute of Medical Sciences Islamabad: a retrospective study. J Ayub Med Coll Abbottabad. 2008 Jul-Sep;20(3):84-7.
- Background: PubMed 30223983Petti S, Andreasen JO, Glendor U, Andersson L. The fifth most prevalent disease is being neglected by public health organisations. Lancet Glob Health. 2018 Oct;6(10):e1070-e1071. doi: 10.1016/S2214-109X(18)30380-2. No abstract available.
- Background: PubMed 22238740Piovesan C, Abella C, Ardenghi TM. Child oral health-related quality of life and socioeconomic factors associated with traumatic dental injuries in schoolchildren. Oral Health Prev Dent. 2011;9(4):405-11.
- Background: PubMed 16499629Feliciano KM, de Franca Caldas A Jr. A systematic review of the diagnostic classifications of traumatic dental injuries. Dent Traumatol. 2006 Apr;22(2):71-6. doi: 10.1111/j.1600-9657.2006.00342.x.
- Background: PubMed 22971023Hermann NV, Lauridsen E, Ahrensburg SS, Gerds TA, Andreasen JO. Periodontal healing complications following extrusive and lateral luxation in the permanent dentition: a longitudinal cohort study. Dent Traumatol. 2012 Oct;28(5):394-402. doi: 10.1111/edt.12000. Epub 2012 Sep 12.
- Background: PubMed 33339132Spinas E, Pipi L, Dettori C. Extrusive Luxation Injuries in Young Patients: A Retrospective Study with 5-Year Follow-Up. Dent J (Basel). 2020 Dec 16;8(4):136. doi: 10.3390/dj8040136.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arshad Hasan, BDS, FCPS study director
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splint retained by Bulk-fill flowable and Splint retained by Packable Composite in people with Dental Trauma and Splints, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of splint (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05305586, which also lists 82 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.