- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05734027
COMPARISON OF SECTIONAL MATRIX VERSUES CIRCUMFERENTIAL MATRIX FOR RECONSTRUCTION OF PROXIMAL CONTACT IN CLASS 2 RESTORATIONS
February 9, 2023 updated by: sheejia asif, Pakistan Institute of Medical Sciences
Class II caries affects proximal surfaces of premolars and maintain their anatomical proximal contact of tooth, is important to avoid food impaction in the interdental area for protection of periodontium and occurrence of secondary carious lesion.Different types of Matrix band system are used to restore tooth cavities with missing proximal walls, including flat or pre-contoured bands, retainer-fixed circumferential systems, and sectional matrices, and either metal or plastic matrices which produces good contours and contacts for use with amalgam and can also be employed for insertion of composite resin.This study aimed at assessing the influence of different matricing techniques :either sectional matrix or circumferential matrix and the influence of operator experience on reproduction of optimum proximal contacts for posterior proximal resin composite restorations.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Local anesthesia will be administrated, and the whole quadrant containing the offending tooth will be isolated by using a rubber dam.After caries removal and cavity preparation, matrix systems will be applied by dentist ; using either a sectional matrix system and circumferential matrix system.A properly sized wedge will be used with both systems to secure both matrices in place cervically and to prevent gingival overhangs , Resin composite restorations will be completed according to the manufacturer's instructions.
Selective enamel etching will be performed by using etchant followed by applying Single Bond Universal adhesive to the entire surface of the enamel and dentin.
Then, a thin layer of flowable composite will be applied to ensure adaptation at the gingival margin.
Finally, prepared cavities will be restored by using resin composite.
using the centripetal technique to build a proximal wall initially followed by successive cusp building.
Restorations will be finished by using a flame-shaped finishing stone and polished, and the occlusal contact points will be checked by using a articulating paper.
Tightness of proximal contacts will be evaluated using dental floss .
For assessment of the restoration, the patients will be sitting in a dental unit with a standardized seating position, which will be reproduced by the unit's preset positioning system, and assessors evaluated the proximal contact by using unwaxed dental floss following theFDI recommendations accordingly to be either optimum, tight, or open contact.Proximal contacts will be categorized as optimum, open, and tight; if the dental floss passed through the contact area as natural dentition on the other side, it will be considered as an optimum contact point.
Open contact points will be considered when the dental floss passed through the contact area without resistance; however, when the dental floss could not be passed at all or tore, proximal contact will be considered as tight.
Study Type
Interventional
Enrollment (Anticipated)
80
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
-
-
-
Islamabad, Pakistan, 04403
- Recruiting
- Pims ,school of dentistry
-
-
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 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Tooth with compound class 2 cavities Patient with good general health. Patient with minimum age of 18 years. Fully erupted occluding premolar and molar teeth.
Exclusion Criteria:
Tooth complex class 2 cavities. Tooth with severe periodontal disease. Diastema between posterior teeth. Third molars are excluded.
. Tooth mobility greater than 1 mm.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sectional matrix band
precontoured sectional matrix band
|
The sectional matrix is the best way to achieve a strong contact point in Class II restorations with composite resin in the posterior dental sector.
The pre-wedging is essential to get a separation between teeth which avoid the matrix deformation during its insertion
Circumferential matrix (thickness 0.038mm) ,the band encircle the tooth and secured by retainer on the buccal and lingual aspect
|
Active Comparator: Circumferential matrix band
Circumferential matrix band applied by tofflemire retainer
|
The sectional matrix is the best way to achieve a strong contact point in Class II restorations with composite resin in the posterior dental sector.
The pre-wedging is essential to get a separation between teeth which avoid the matrix deformation during its insertion
Circumferential matrix (thickness 0.038mm) ,the band encircle the tooth and secured by retainer on the buccal and lingual aspect
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tightness of proximal contact
Time Frame: immediately after the procedure
|
Proximal contact either optimum, tight, or open contact by using dental floss
|
immediately after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
August 27, 2022
Primary Completion (Anticipated)
March 2, 2023
Study Completion (Anticipated)
March 10, 2023
Study Registration Dates
First Submitted
February 9, 2023
First Submitted That Met QC Criteria
February 9, 2023
First Posted (Actual)
February 17, 2023
Study Record Updates
Last Update Posted (Actual)
February 17, 2023
Last Update Submitted That Met QC Criteria
February 9, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOD/ERB/2023/18
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.
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