Restoring of primary anterior teeth destroyed due to caries

ISRCTN ISRCTN24235778
DOI https://doi.org/10.1186/ISRCTN24235778
Secondary identifying numbers 2698
Submission date
20/06/2019
Registration date
09/07/2019
Last edited
16/07/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Seba Ibrahim
Scientific

Lattakia
Lattakia
00963
Syria

ORCiD logoORCID ID 0000-0002-6813-0421
Phone +963 (0)999435213
Email seba.ibrahim1@gmail.com

Study information

Study designInterventional double-blind randomized trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleClinical and radiographic comparative study to evaluate the efficacy of restoring destroyed primary incisors using two different techniques
Study objectivesThere is no difference between glass fiber post technique and composite post technique in restoring destroyed primary incisors.
Ethics approval(s)The Institutional Review Board of Tishreen University, 07/06/2016, Approval No. 2698
Health condition(s) or problem(s) studiedManagement of destroyed primary incisors due to early childhood caries
InterventionThe 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 typeProcedure/Surgery
Primary outcome measureRetention 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 measures1. 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 study start date24/04/2016
Completion date01/09/2019

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Years
Upper age limit5 Years
SexBoth
Target number of participants36 teeth
Total final enrolment36
Key inclusion criteria1. 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)
Key exclusion criteria1. Mobility of the teeth
2. Subgingival crown destruction
Date of first enrolment09/11/2017
Date of final enrolment22/03/2019

Locations

Countries of recruitment

  • Syria

Study participating centre

Tishreen University
Lattakia
Lattakia
00963
Syria

Sponsor information

Tishreen University
University/education

Lattakia
Lattakia
00963
Syria

Phone +963 (0)941450850
Email abdulnourallah@tishreen.edu.sy
Website www.tishreen.edu.sy
ROR logo "ROR" https://ror.org/04nqts970

Funders

Funder type

University/education

Tishreen University

No information available

Results and Publications

Intention to publish date11/09/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact reviewed journal.
IPD sharing planThe datasets generated during and/or analyzed during the current study are/will be available upon request from Dr Seba Ibrahim (seba.ibrahim1@gmail.com).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2020 16/07/2020 Yes No

Editorial Notes

16/07/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
09/07/2019: Trial's existence confirmed by Institutional Review Board.