Plain English Summary
Background and study aims
Primary anterior teeth that have been destroyed due to trauma or caries in very young children are hard to treat with dental restorations due to many reasons, especially the small amount of remaining tooth body, which cannot support the restoration. The only treatment of such cases was to extract the affected teeth, but this may cause many problems to the child such as aesthetic problems and speech problems. Short glass fiber post restorations and short composite post restorations are two different techniques that may be used to reconstruct the destroyed primary anterior teeth since the post will be inserted into the root canal of the teeth so it supports the crown restoration. The aim of this study is compare the effectiveness of using short glass fiber posts and short composite posts to support the aesthetic restorations of destroyed primary anterior teeth.
Who can participate?
Children with destroyed upper primary anterior teeth
What does the study involve?
Chosen teeth are randomly allocated into two groups for restorations supported with either short glass fiber post or short composite post. All teeth are assessed clinically at 3, 6, 9 and 12 months and radiographically at 6 and 12 months after treatment.
What are the possible benefits and risks of participations?
The treatment may prevent the extraction of the affected teeth and re-build their appearance and function. There are no known risks to participants as any failed treatments will be re-done using another method.
Where is the study run from?
Department of Pediatric Dentistry, Tishreen University, Lattakia (Syria)
When is the study starting and how long is it expected to run for?
April 2016 to September 2019
Who is funding the study?
Tishreen University (Syria)
Who is the main contact?
1. Dr Seba Ibrahim
seba.ibrahim1@gmail.com
2. Dr Abdul Wahab Nourallah
abdulnourallah@tishreen.edu.sy
Trial website
Contact information
Type
Scientific
Primary contact
Dr Seba Ibrahim
ORCID ID
http://orcid.org/0000-0002-6813-0421
Contact details
Lattakia
Lattakia
00963
Syria
+963 (0)999435213
seba.ibrahim1@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2698
Study information
Scientific title
Clinical and radiographic comparative study to evaluate the efficacy of restoring destroyed primary incisors using two different techniques
Acronym
Study hypothesis
There is no difference between glass fiber post technique and composite post technique in restoring destroyed primary incisors.
Ethics approval
The Institutional Review Board of Tishreen University, 07/06/2016, Approval No. 2698
Study design
Interventional double-blind randomized trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Management of destroyed primary incisors due to early childhood caries
Intervention
The destroyed teeth of the participants were consecutively allocated to either group A or group B. Group A received restorations supported with glass fiber posts, and group B received restorations supported with composite posts. Participants were asked to attend follow-up examinations with clinical evaluations at 3, 6, 9 and 12 months post- treatment and radiographic evaluations at 6 and 12 months.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Retention of the restorations evaluated according to the FDI criteria (World Dental Federation) clinically using visual inspection and dental explorer at 3, 6, 9 and 12 months post-treatment.
The outcome is considered to be successful if the post and crown were in situ with no debonding or fracture of the post or the root or the crown.
Secondary outcome measures
1. Secondary caries evaluated clinically using visual inspection at 3, 6, 9 and 12 months post-treatment and radiographically at 6 and 12 months post-treatment
2. Marginal integrity evaluated clinically using visual inspection and dental explorer at 3, 6, 9 and 12 months post-treatment
The outcome is considered to be successful if there are no secondary caries and no marginal gapping reaches to the dento-enamel junction.
Overall trial start date
24/04/2016
Overall trial end date
01/09/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy children with no medical histories
2. No malocclusion and no abnormal oral activities
3. Aged from 2 to 5 years old
4. Destroyed maxillary primary incisors (more than 50% of the crowns)
5. Sound root structure (external resorption not more than one third of the root)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
36 teeth
Total final enrolment
36
Participant exclusion criteria
1. Mobility of the teeth
2. Subgingival crown destruction
Recruitment start date
09/11/2017
Recruitment end date
22/03/2019
Locations
Countries of recruitment
Syria
Trial participating centre
Tishreen University
Lattakia
Lattakia
00963
Syria
Sponsor information
Organisation
Tishreen University
Sponsor details
Lattakia
Lattakia
00963
Syria
+963 (0)941450850
abdulnourallah@tishreen.edu.sy
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Tishreen University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact reviewed journal.
IPD sharing statement
The datasets generated during and/or analyzed during the current study are/will be available upon request from Dr Seba Ibrahim (seba.ibrahim1@gmail.com).
Intention to publish date
11/09/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 results in https://doi.org/10.1002/cre2.307 (added 16/07/2020)