Is it necessary to add chlorhexidine to a glass-ionomer restorative?

ISRCTN	ISRCTN16774328
DOI	https://doi.org/10.1186/ISRCTN16774328
Secondary identifying numbers	NRC280108

Submission date: 28/12/2017
Registration date: 04/02/2018
Last edited: 29/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Enas Mobarak
Scientific

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

Study information

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
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	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(s)	The ethical committee at the National Research Center, Ministry of Health and Population, Government Health Insurance in Egypt, 14/10/2007, ref: NRC280108
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	14/04/2007
Completion date	15/05/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	100
Key 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
Key exclusion criteria	1. Poor oral hygiene 2. Deciduous teeth 3. Patients declaring daily consumption of substantial volume of citric juices
Date of first enrolment	15/01/2008
Date of final enrolment	14/02/2009

Locations

Countries of recruitment

Egypt

Study participating centre

Dental School Cairo University

Cairo
20711

Sponsor information

Dental School University of Cairo
University/education

11 El Saraya st. Manial
Cairo
20177
Egypt

"ROR"	https://ror.org/03q21mh05

Funders

Funder type

University/education

Cairo University
Private sector organisation / Universities (academic only)

Alternative name(s): CU
Location: Egypt

Radboud Universitair Medisch Centrum
Private sector organisation / Universities (academic only)

Alternative name(s): Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC
Location: Netherlands

GC Europe, Belgium

No information available

Results and Publications

Intention to publish date	31/12/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The manuscript has been submitted.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Radboud University Medical Centre.