NCT05734027

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 9, 2023

Last Update Submit

February 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tightness of proximal contact

    Proximal contact either optimum, tight, or open contact by using dental floss

    immediately after the procedure

Study Arms (2)

Sectional matrix band

EXPERIMENTAL

precontoured sectional matrix band

Device: Sectional matrixDevice: Circumferential matrix

Circumferential matrix band

ACTIVE COMPARATOR

Circumferential matrix band applied by tofflemire retainer

Device: Sectional matrixDevice: Circumferential matrix

Interventions

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 bandSectional matrix band

Circumferential matrix (thickness 0.038mm) ,the band encircle the tooth and secured by retainer on the buccal and lingual aspect

Circumferential matrix bandSectional matrix band

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Tooth complex class 2 cavities. Tooth with severe periodontal disease. Diastema between posterior teeth. Third molars are excluded.
  • Tooth mobility greater than 1 mm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pims ,school of dentistry

Islamabad, 04403, Pakistan

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

sheejia Asif, Bds

CONTACT

Aqsa Waheed, Bds

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 17, 2023

Study Start

August 27, 2022

Primary Completion

March 2, 2023

Study Completion

March 10, 2023

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations