Condition category
Oral Health
Date applied
03/02/2019
Date assigned
15/02/2019
Last edited
22/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Atraumatic restorative treatment (ART) is an approach to dental treatment that uses only hand-powered instruments. Electricity, anaesthetics and advanced tools are not needed, which means that this approach can be used in developing countries to treat dental cavities, which are otherwise often treated by removing the tooth. ART can also be used in patients who have a dental phobia. However, ART treatment of teeth with complex cavities can have a higher chance of failing than conventional treatment. This trial aims to investigate compare two types of cement material used to fill cavities using the ART approach.

Who can participate?
Secondary school students aged 15 or 16 years who have at least one premolar or molar tooth with decay that has resulted in a cavity.

What does the study involve?
Participants will be randomly allocated to one of two groups. Participants in both groups will have their cavities treated using ART. The cavities will be filled with one filler or the other depending on which group they were allocated to. The participants will come back for a dental examination at 1 week and 6, 12, 18 and 24 months after the treatment and the success of the tooth restoration will be assessed each time.

What are the possible benefits and risks of participating?
The procedure is the same for both groups and might involve some discomfort when the decay is being cleaned out of the cavity. One of the fillers might result in a lower chance of the filling and the tooth remaining sound.

Where is the study run from?
Cairo University Dental School (Egypt)

When is the study starting and how long is it expected to run for?
November 2010 to May 2016

Who is funding the study?
The researcher is funding the study.

Who is the main contact?
Enas Mobarak, enasmobarak@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Enas Mobarak

ORCID ID

Contact details

Faculty of Oral and Dental Medicine
Cairo University
11 El Saraya Street
Manial
Cairo
12311
Egypt

Type

Scientific

Additional contact

Dr Jo Frencken

ORCID ID

http://orcid.org/0000-0001-9612-1752

Contact details

Radboud University College of Dental Science
Nijmegen
6525 XZ
Netherlands
-
Jo.Frencken@radboudumc.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

RHD-IRB0000687-13oct2014-EM02

Study information

Scientific title

Survival of multiple-surface ART restorations using a zinc-reinforced glass-ionomer restorative after 2 years: A randomized triple-blind clinical trial

Acronym

Study hypothesis

The survival of multiple-surface atraumatic restorative treatment (ART) zinc-reinforced high-viscosity glass-ionomer cement (HVGIC) restorations in permanent posterior teeth is significantly higher than that of comparable restorations using conventional HVGIC after 2 years.

Ethics approval

Approved 13/10/2014, ethical committee at Ministry of Health and Population, Government Health Insurance in Egypt, ref: RHD-IRB0000687-13Oct2014-EM02

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Tooth cavity in more than one surface

Intervention

Randomisation:
The test intervention was a new restorative material (zinc-containing glass-ionomer cement [ChemFil Rock]). The control intervention was a commonly used glass-ionomer material, FUJI IX GP. First a computer programme randomised a test/control restoration over the four operators and by gender. Using envelopes with marks for gender, the student chose the envelope of his/her gender and presented it to a third person who, using a randomised list of restorative materials, informed the operator which restorative was to be used. The intervention was masked for operator, evaluation (using replicas) and statistician (test-control group only known by chief investigator).

Intervention:
Tooth cavities were prepared entirely using hand instruments. Soft carious dentine was excavated using ART hand excavators. Then the cavity was wiped with water-soaked cotton pellets, dried using dry cotton pellets and cautiously inspected for the presence of soft dentine, which was then removed when necessary.
In the control arm, a dentine conditioner was applied to the floor and the walls of the prepared cavity for 10 s. The conditioner was rinsed out using a cotton pellet soaked in water until no remnant of the conditioner was visible (about 10 s). Then, the cavity was blotted using dry cotton pellets (5 s). This procedure was not performed in the test arm. A prefabricated matrix band and a wedge were inserted. A high-viscosity glass-ionomer cement (HVGIC) was the filling material. In the test group, HVGIC Chemfil Rock was inserted in the tooth cavity and in the control arm, HVGIC Fuji IX GP was used. Excess HVGIC was removed with a large excavator and ART contouring instrument and left to harden for 25-30 s. The wooden wedge and matrix band were then removed and the height of the filling was checked using an articulating paper. Participants were instructed neither to eat nor to brush the restored side of the mouth for at least 2 h, and to brush the teeth twice daily with a fluoride containing toothpaste every day thereafter. The participant was also advised to contact the operator in case of having any dental problems or pain.

Evaluation:
Using intra-oral photographic mirrors, digital clinical photographs of the occlusal and approximal surfaces were taken preoperatively after cavity preparation and postoperatively at baseline (1 week post-restoration) and at each of the four follow-up time points (6, 12, 18 and 24 months) using a digital camera Nikon D40 and a Macro lens supplied with a ring flash.
A replica of each restored tooth was produced at each of the evaluation points. Two independent evaluators assessed the restorations using ART restoration assessment criteria and those of the FDI (World Dental Federation). In case of disagreement, the case was discussed and consensus reached. Restoration survival curves were estimated and difference between variables were tested with a Wald (chi-square) test.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Survival of multiple-surface ART restorations after 2 years

Secondary outcome measures

Main reason for failure of restorations after 2 years

Overall trial start date

01/11/2010

Overall trial end date

31/05/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Secondary school students
2. Healthy patients without any history of any medical condition that could interfere with the study protocol or affect clinical results
3. Good oral hygiene (Simplified Oral Hygiene Index (S-OHI ≤0.5%)
4. Caries prevalence (DMFS) <12
5. Without adverse oral habits that could affect the study results
6. Presence of natural antagonist tooth that is not restored
7. Presence of at least one tooth with a cavitated or dentine carious lesions including at least occlusal-proximal (multi-surface) surface in first or second permanent premolars/molars situated in any side of the jaw
8. Presence of adjacent tooth to the cavity and being fully erupted, normally positioned (not titled or rotated) and having natural (not restored) contact
9. Occluso-proximal cavities with size (Site/Stage 2.2, 2.3 and 2.4)
10. Absence of apparent enamel crack or fracture
11. No pulp involvement or symptoms of pulpitis or apical periodontitis

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Targeted number was 106 females and 106 males

Total final enrolment

218

Participant exclusion criteria

1. Teeth without antagonist teeth or with a prosthetic antagonist
2. Occlusal-proximal cavities limited to enamel layer
3. Deciduous teeth
4. Abnormal oral habits with excessive occlusal function or parafunction, such as pencil chewing or bruxism
5. Daily consumption of citrus juices

Recruitment start date

01/03/2012

Recruitment end date

01/05/2014

Locations

Countries of recruitment

Egypt

Trial participating centre

Cairo University Dental School
14 El Ansar Street Dokki
Cairo
12311
Egypt

Trial participating centre

Radboud University Medical Centre
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Sponsor information

Organisation

Dental School, University of Cairo

Sponsor details

11 El Saraya Street
Manial
Cairo
12311
Egypt

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study was published as part of the PhD thesis of Dr. E. Mobarak who defended her thesis successfully on 20th December 2018 at the Radboud University in Nijmegen. A journal article manuscript is expected to be submitted by the end of February 2019.

IPD sharing statement:
The data were stored at the Radboud University Medical Centre, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands. The availability of the data is unknown and there is no data sharing plan.

Intention to publish date

31/08/2019

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/02/2019: Internal review. 08/02/2019: Trial's existence confirmed by Radboud University.