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
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
Scientific
Lattakia
Lattakia
00963
Syria
 ORCID ID |
0000-0002-6813-0421 |
|---|---|
| Phone | +963 (0)999435213 |
| seba.ibrahim1@gmail.com |
Study information
| Study design | Interventional double-blind randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Clinical and radiographic comparative study to evaluate the efficacy of restoring destroyed primary incisors using two different techniques |
| Study objectives | There 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) studied | 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 |
| 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 study start date | 24/04/2016 |
| Completion date | 01/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 36 teeth |
| Total final enrolment | 36 |
| Key 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) |
| Key exclusion criteria | 1. Mobility of the teeth 2. Subgingival crown destruction |
| Date of first enrolment | 09/11/2017 |
| Date of final enrolment | 22/03/2019 |
Locations
Countries of recruitment
- Syria
Study participating centre
Lattakia
00963
Syria
Sponsor information
University/education
Lattakia
Lattakia
00963
Syria
| Phone | +963 (0)941450850 |
|---|---|
| abdulnourallah@tishreen.edu.sy | |
| Website | www.tishreen.edu.sy |
"ROR" |
https://ror.org/04nqts970 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 11/09/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact reviewed journal. |
| IPD sharing plan | 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). |
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.
