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
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
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