Plain English Summary
Background and study aims
Cavity restoration refers to the dental treatment used to treat a hole in the tooth (for example, caries or injury). Matrix band systems are made up of a piece of metal or other material and are used to support and give form to the cavity restoration being used (for example, a dental filling) both when its being applied and then when its hardening in the tooth. Matrices are used to try and ensure the end result is similar in shape to that of the original tooth. The aim of this study was to compare two different types of matrix band system (circumferential matrix system and sectional matrix system) to see which is the best at duplicating the natural structure of the tooth.
Who can participate?
Adults (aged over 18) that need cavity restoration treatment.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 have cavity restoration treatment using the circumference matrix band system. This is the oldest established matrix band system used in dentistry and it still widely used. Participants in group 2 have cavity restoration treatment using the much newer sectional matrix system. Both systems were assessed in terms of their ability to duplicate the natural shape and structure of the teeth immediately after treatment.
What are the possible benefits and risks of participating?
Benefits include the participants having dental treatment and having their cavities restored using one of the two were receiving restorations using one of the above mentioned matrix band system technique. There were no risks involved in this study.
Where is the study run from?
College of Dentistry, Qassim University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
December 2014 to June 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr Durre Sadaf (public)
2. Dr Muhammad Zubair Ahmad (scientific)
dr.zubair.ahmad@qudent.org
Trial website
Contact information
Type
Public
Primary contact
Dr Durre Sadaf
ORCID ID
Contact details
Conservative Dental Sciences Department
College of Dentistry
Qassim University
Mullaydha
Buraidah
51452
Saudi Arabia
Type
Scientific
Additional contact
Dr Muhammad Zubair Ahmad
ORCID ID
Contact details
Conservative Dental Sciences Department
College of Dentistry
Qassim University
Mullaydha
Buraidah
51452
Saudi Arabia
00966582527047
dr.zubair.ahmad@qudent.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16031979
Study information
Scientific title
Comparison of two different matrix band systems in restoring two surface cavities in posterior teeth done by senior undergraduate students at Qassim University, Saudi Arabia: a randomized controlled clinical trial
Acronym
Study hypothesis
There is no difference between two matrix band systems when restoring class 2 cavities in posterior teeth
Ethics approval
Dental Research Centre (DRC), College of Dentistry, Qassim University, Saudi Arabia, 11/12/2014, ref: EA/76/2014
Study design
Randomised controlled clinical 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 the contact details to request a patient information sheet
Condition
Class 2 cavities in posterior teeth
Intervention
Matrix band systems are used to restore cavities with missing proximal walls. This helps in adequate condensation and placement of restorative material which duplicates natural tooth structure, contacts and contours. A good placement of matrix band system eliminates the risk of food impaction, dental caries and gingival and periodontal diseases.
Adult participants requiring cavity restoration work were recruited into this study and treated by senior undergraduate students. They are randomly allcoated to one of two groups:
Group 1: Participants in this group underwent cavity restoration treatment using the circumference matrix band system (control group). Circumferential matrix band system, as name indicates is a matrix band system that wraps around the tooth. Also known as Tofflemire matrix band system, it is still widely used in dentistry, taught and practiced in preclinical and clinical years of all dental schools. The key advantage of working with this system is ease of use in restoring large surface defects in teeth. Matrix bands can be placed ahead of time so it becomes very easy to place this system on a prepared tooth and then to place final restoration. This band is available in various heights and thicknesses.
Group 2: Participants in this group underwent cavity restoration treatment using the sectional matrix band system (intervention). Sectional matrix band systems are relatively new and can be used as an alternative to circumferential matrix band system. Combined with the additional force provided by separating rings, this system produces reliable proximal contacts even if there are spaces present between teeth.
For all participants in both groups teeth were restored using either the composite using multilayered technique or amalgam. Contact points were then evaluated using dental floss. Presence or absence of proximal overhangs were assessed with digital bitewing radiographs. Since the outcome variables were assessed immediately after this cavity restorations, no follow up visits were required for this study.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Contact points, measured using dental floss, assessed immediately after cavity restoration (dental fillings)
Secondary outcome measures
Proximal overhanging margins, measured using intra-oral digital bitewing radiographs and categorized as positive overhangs, negative overhangs and absent overhangs. Assessed immediately after cavity restoration (dental fillings)
Overall trial start date
20/12/2014
Overall trial end date
02/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with good general health
2. Minimum age of 18
3. Fully erupted occluding premolars and molars teeth
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1074 patients participated in this study
Participant exclusion criteria
1. Severe periodontal diseases
2. Diastema between posterior teeth
3. Third molar teeth
4. Presence of fixed partial dentures and tooth mobility more than score 1
Recruitment start date
20/12/2014
Recruitment end date
02/06/2016
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
College of Dentistry, Qassim University
Department of Conservative Dentistry
Buraydha
51452
Saudi Arabia
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
Intend to publish in indexed journal
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/12/2016
Participant level data
To be made available at a later date
Basic results (scientific)
See additional file: ISRCTN18179115_BasicResults_28Sep16
Publication list
Publication citations
Additional files
- ISRCTN18179115_BasicResults_28Sep16.docx Uploaded 10/10/2016