- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03795727
Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact
April 17, 2020 updated by: Omar Osama Shaalan, Cairo University
Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact by Undergraduate Students and Postgraduate Dentists: Randomized Controlled Trial
The aim of this study is to evaluate the effects of different matricing techniques either sectional matrix or circumferential matrix on reproduction of optimum proximal contacts and contours during restoration of class II cavities with resin composite by undergraduate students or postgraduate dentists.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
El Manial
-
Cairo, El Manial, Egypt, 11553
- Faculty of Dentistry, Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Compound class II cavities
- Good oral hygiene
- No spacing or crowding
- Healthy peridontium
Exclusion Criteria:
- Complex class II cavities
- Poor oral hygiene
- Spacing or crowding
- Evidence of peridontal disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sectional matrix
precontoured sectional matrix band
|
MD ring (separation ring) and precontoured sectional matrix (thickness 0.035mm hard) and a wedge was used to secure matrix in place
|
|
Active Comparator: Circumferential matrix
Circumferential matrix band applied by tofflemire retainer
|
Circumferential matrix (thickness 0.038mm) applied by tofflemire retainer and secured in place with wedge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proximal contact
Time Frame: Up to 3 hours from randomization till contact is restored
|
Reproduction of proximal contact either optimum, tight or loose (Categorical)
|
Up to 3 hours from randomization till contact is restored
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2020
Primary Completion (Actual)
February 12, 2020
Study Completion (Actual)
March 12, 2020
Study Registration Dates
First Submitted
January 3, 2019
First Submitted That Met QC Criteria
January 4, 2019
First Posted (Actual)
January 8, 2019
Study Record Updates
Last Update Posted (Actual)
April 21, 2020
Last Update Submitted That Met QC Criteria
April 17, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- circumferential vs sectional
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.