Condition category
Oral Health
Date applied
20/06/2019
Date assigned
09/07/2019
Last edited
09/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

www.tishreen.edu.sy

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

Publication citations

Additional files

Editorial Notes

09/07/2019: Trial's existence confirmed by Institutional Review Board.