COMPARISON OF SECTIONAL MATRIX VERSUES CIRCUMFERENTIAL MATRIX FOR RECONSTRUCTION OF PROXIMAL CONTACT IN CLASS 2 RESTORATIONS
Primary Purpose
Tooth Decay
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Sectional matrix
Circumferential matrix
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Decay
Eligibility Criteria
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.
Sites / Locations
- Pims ,school of dentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sectional matrix band
Circumferential matrix band
Arm Description
precontoured sectional matrix band
Circumferential matrix band applied by tofflemire retainer
Outcomes
Primary Outcome Measures
Tightness of proximal contact
Proximal contact either optimum, tight, or open contact by using dental floss
Secondary Outcome Measures
Full Information
NCT ID
NCT05734027
First Posted
February 9, 2023
Last Updated
February 9, 2023
Sponsor
Pakistan Institute of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05734027
Brief Title
COMPARISON OF SECTIONAL MATRIX VERSUES CIRCUMFERENTIAL MATRIX FOR RECONSTRUCTION OF PROXIMAL CONTACT IN CLASS 2 RESTORATIONS
Official Title
COMPARISON OF SECTIONAL MATRIX VERSUES CIRCUMFERENTIAL MATRIX FOR RECONSTRUCTION OF PROXIMAL CONTACT IN CLASS 2 RESTORATIONS
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2022 (Actual)
Primary Completion Date
March 2, 2023 (Anticipated)
Study Completion Date
March 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pakistan Institute of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Decay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sectional matrix band
Arm Type
Experimental
Arm Description
precontoured sectional matrix band
Arm Title
Circumferential matrix band
Arm Type
Active Comparator
Arm Description
Circumferential matrix band applied by tofflemire retainer
Intervention Type
Device
Intervention Name(s)
Sectional matrix
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Circumferential matrix
Intervention Description
Circumferential matrix (thickness 0.038mm) ,the band encircle the tooth and secured by retainer on the buccal and lingual aspect
Primary Outcome Measure Information:
Title
Tightness of proximal contact
Description
Proximal contact either optimum, tight, or open contact by using dental floss
Time Frame
immediately after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sheejia Asif, Bds
Phone
03165518512
Email
sheejiaasif344@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aqsa Waheed, Bds
Phone
03063422518
Email
q.aqsa@rocketmail.com
Facility Information:
Facility Name
Pims ,school of dentistry
City
Islamabad
ZIP/Postal Code
04403
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheejia Asif, BDS
Phone
03165518512
Email
sheejiaasif@gmail.com
First Name & Middle Initial & Last Name & Degree
Aqsa waheed, BDS
Phone
03063422518
Email
q.aqsa@rocketmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COMPARISON OF SECTIONAL MATRIX VERSUES CIRCUMFERENTIAL MATRIX FOR RECONSTRUCTION OF PROXIMAL CONTACT IN CLASS 2 RESTORATIONS
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