Condition category
Oral Health
Date applied
28/12/2017
Date assigned
04/02/2018
Last edited
29/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
High-viscosity glass-ionomer (HVGIC) is a material that is used for tooth restorations (fillings). When preparing the tooth cavities, bacteria can be left behind, and some dentists think that new cavities can start. Other dentists disagree. Chlorhexidine (CHX) has antibacterial properties. Laboratory studies showed that HVGIC containing chlorhexidine (HVGIC/CHX) kills certain species of bacteria. The aim of this study is to find out whether HVGIC/CHX is more effective at preventing new cavities than HVGIC.

Who can participate?
Adolescents with at least two small/medium-sized cavities

What does the study involve?
Participants’ cavities are randomly allocated to be restored with either HVGIC/CHX or HVGIC. The method is special as no drill is used in preparing the tooth cavity. Cavity preparation is done by hand instruments, which makes this method much more acceptable for the public and safer as less tooth tissue is removed compared to the drill method. Usually no anaesthetic is needed as pain is absent or very much reduced. The quality of the restoration and the presence of cavities are assessed after 0.5, 1, 1.5 and 2 years.

What are the possible benefits and risks of participating?
Not provided at time of registration

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

When is the study starting and how long is it expected to run for?
April 2007 to May 2009

Who is funding the study?
1. Cairo University (Egypt)
2. Radboud University Medical Center (Netherlands)
3. GC Europe (Belgium)

Who is the main contact?
Prof. Enas Mobarak

Trial website

Contact information

Type

Scientific

Primary contact

Prof Enas Mobarak

ORCID ID

Contact details

Faculty of Oral and Dental Medicine
Cairo University
Mailing address: 11 El Saraya st. Manial
Cairo
12311
Cairo
20177
Egypt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NRC280108

Study information

Scientific title

Survival of occlusal ART restorations with and without chlorhexidine containing high-viscosity glass-ionomer: a 2-year split-mouth quadruple-blind randomized controlled clinical pilot trial

Acronym

Study hypothesis

Would the use of HVGIC/CHX be more effective in preventing the occurrence of secondary carious lesions than HVGIC and would the survival of HVGIC/CHX restorations be higher than HVGIC restorations in occlusal cavities in permanent teeth treated according to ART?

Ethics approval

The ethical committee at the National Research Center, Ministry of Health and Population, Government Health Insurance in Egypt, 14/10/2007, ref: NRC280108

Study design

24-month follow-up prospective randomized controlled split-mouth quadruple-blinded (operator, patients, evaluators and statistician) clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Dental cavitated teeth

Intervention

Considered a pilot study, a convenient sample size of 100 students per treatment group was chosen. Randomization of the two restoratives over the prepared cavities was performed as follows: 100 identical opaque sealed envelopes were prepared which included a number between 1 and 100. Each eligible student was asked to choose one envelop. The chosen number was taken as his/her identity code. If the number was an odd one, the molar at the right side was restored with material I and the molar at the left side with material II. If an even number was chosen, the molar at the right side was restored with material II and the left sided molar with material I.

Patients with at least two small-medium-sized occlusal cavities were included. Occlusal cavities were prepared according to the Atraumatic Restorative Treatment (ART) method and restored with either:
1. High-viscosity glass-ionomer with chlorhexidine (HVGIC/CHX) (test)
2. High-viscosity glass-ionomer (HVGIC) (control)

A replica of all restorations available and digital photographs were made at baseline and after 0.5, 1, 1.5 and 2 years, and evaluated by two examiners using the ART and FDI restoration assessment criteria. Estimation of survival curves was done with the Kaplan-Meier method. The logrank test was used to test for significance between the survival rates.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Development of secondary carious lesions, assessed using the USPHS criteria at baseline, 6, 12,18 and 24 months

Secondary outcome measures

Quality of the restorations, assessed using ART restoration criteria at baseline, 6, 12,18 and 24 months

Overall trial start date

14/04/2007

Overall trial end date

15/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy patients without a history of any medical disease or condition that could interfere with the study protocol or affect clinical results
2. Patients without oral habits that could affect the study results
3. Presence of natural antagonist
4. Presence of at least two teeth with a cavitated dentine carious lesions in an occlusal surface in first or second permanent molars situated in different sides of the jaw
5. Occlusal cavities with size (Site/Stage 1.2 or 1.3)
6. Absence of apparent enamel crack or fracture
7. No pulp involvement or symptoms of pulpitis or apical periodontitis

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Poor oral hygiene
2. Deciduous teeth
3. Patients declaring daily consumption of substantial volume of citric juices

Recruitment start date

15/01/2008

Recruitment end date

14/02/2009

Locations

Countries of recruitment

Egypt

Trial participating centre

Dental School Cairo University
Cairo
20711

Sponsor information

Organisation

Dental School University of Cairo

Sponsor details

11 El Saraya st. Manial
Cairo
20177
Egypt

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Cairo University

Alternative name(s)

CU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Egypt

Funder name

Radboud Universitair Medisch Centrum

Alternative name(s)

Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Funder name

GC Europe, Belgium

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The manuscript has been submitted.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Radboud University Medical Centre.

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes