Condition category
Oral Health
Date applied
19/09/2016
Date assigned
28/09/2016
Last edited
10/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Qassim University

Sponsor details

University Road
Mullaydha
Buraidah
51452
Saudi Arabia

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

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

Results - basic reporting

See additional file: ISRCTN18179115_BasicResults_28Sep16

Publication summary

Publication citations

Additional files

Editorial Notes

10/10/2016: Results summary uploaded. 29/09/2016: Internal review