Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111664034062 Date of Approval: 29/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical and Radiographic Evaluation of Sectional versus Circumferential Matrix systems: A One-Year Randomized Clinical Trial
Official scientific title Clinical and Radiographic Evaluation of Sectional versus Circumferential Matrix systems: A One-Year Randomized Clinical Trial
Brief summary describing the background and objectives of the trial the objective of this study is to compare the contact tightness and proximal contour of compound proximal restorations using two sectional matrix systems (Garrison & TOR VM) and circumferential matrix system (Tofflemire) over one year follow-up period
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/12/2021
Actual trial start date 07/12/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 24/01/2023
Anticipated target sample size (number of participants) 39
Actual target sample size (number of participants) 39
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Garrison one year Sectional matrix system 13 Active-Treatment of Control Group
Experimental Group TOR VM One year Sectional matrix system 13
Control Group Tofflemire One year Circumferential matrix system 13 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Clinically diagnosed as moderate-or-deep compound class II cavities; no caries detected on other surfaces. 2- Cavities 4mm or more in depth. 3- No signs and symptoms of pulpal and periapical diseases. 4- An opposing or neighboring tooth to the tooth to be restored exists. 1- Clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure. 2- Poor oral hygiene. 3- Periodontal problems. 4- Heavy bruxism habits. 5- Patients with history of allergic reactions to resin materials or any components of the used materials. 6- Pregnant females. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/10/2021 RECO6U
Ethics Committee Address
Street address City Postal code Country
Central Axis Part 1/1 6th October 12585 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proximal contact tightness Baseline, After 6 months, After 12 months
Secondary Outcome Proximal contour Baseline, After 6 months, After 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Conservative Dentistry Department Faculty of Dentistry October 6 University Central Axis - Part 1/1 6th October 12585 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Gamal Abdelwahed Central axis - Part 1/1 6th October 12585 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Gamal Abdelwahed Central axis - Part 1/1 6th October 12585 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Monaliza Maher Abdelaziz Cental axis - Part 1/1 6th October 12585 Egypt
Shereen Essameldein Fahim Cental axis - Part 1/1 6th October 12585 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdelwahed 152704@o6u.edu.eg +21223710009 Central axis - Part 1/1
City Postal code Country Position/Affiliation
6th October 12585 Egypt Lecturer of Conservative Dentistry
Role Name Email Phone Street address
Public Enquiries Monaliza Abdelaziz monalizamaher.dent@o6u.edu.eg +21001400248 Central axis - Part 1/1
City Postal code Country Position/Affiliation
6th October 12585 Egypt Lecturer of Conservative Dentistry
Role Name Email Phone Street address
Scientific Enquiries Shereen Fahim shereenessam.dent@o6u.edu.eg +21001816565 Central axis - Part 1/1
City Postal code Country Position/Affiliation
6th October 12585 Egypt Lecturer of Conservative Dentistry
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Any data will be available upon request. Requests should be directed to 152704@o6u.edu.eg and will be sent by email to the requesting party. Data sharing will by anonymous to protect participants' privacy. Available data include informed consent form, raw data and statistical methods. Informed Consent Form After the end of one-year follow up Requests for any data should be directed to 152704@o6u.edu.eg and shall not be limited to specific institutes/researchers
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information