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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sectional matrix band
precontoured sectional matrix band
Device: Sectional matrix
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
Device: Circumferential matrix
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
Device: Sectional matrix
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
Device: Circumferential matrix
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pakistan Institute of Medical Sciences

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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