Evaluation of Clinical Success of Restorations Using Different Magnification Aids

July 16, 2023 updated by: ipek çubukçu, Ataturk University
This study aimed to investigate the effect of using a loupe and dental operating microscope with different magnifications on the success of class II direct composite restorations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 130 class II, D2 deep caries teeth of 85 patients were randomly distributed to the naked eye, 3x magnification loupe, 5x magnification loupe, 8.5x magnification dental operating microscope (DOM) groups, and direct composite restorations were made with these magnification aids. carried out. Clearfil SE Bond 2 and Clearfil Majesty Posterior composite were used in all restorations. The restorations were evaluated using FDI criteria at 1,6 and 12-month periods, and restorations were scored between 1 and 5 for all criteria.

Study Type

Interventional

Enrollment (Actual)

90

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

  • Turkey
      • Erzurum, Turkey, 25080
        • Ataturk 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Good oral and dental care of the patient,
  • The need for at least 1 Class II restoration at a depth of D2 in the posterior group teeth,
  • No crowding in the tooth to be restored, tooth contact and antagonist,
  • The relevant tooth is vital,
  • Absence of pain on percussion and palpation of the tooth.
  • Absence of any pathology in the periapical tissues in radiographic evaluation,
  • The patient was informed about the study and accepted the study,
  • Having agreed to attend 1 month, 6 month and 12 month control sessions,
  • The patient has no systemic disease,

Exclusion Criteria:

  • Presence of severe periodontal disease,
  • Teeth that cannot be insulated, malposed or overloaded or not loaded at all,
  • Periodontal and endodontic removal of the relevant tooth is healthy,
  • the patient is undergoing orthodontic treatment,
  • Recording of dry mouth is set,
  • Severe bruxism habit,
  • Smoking

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: with no magnification aid treatment
Dental caries treatment with no magnification aid
Active Comparator: with x2 dental loupe
Dental caries treatment with x2 dental loupe
Device: Dental Loupe
Magnification aid
Active Comparator: with x5 dental loupe
Dental caries treatment with x5 dental loupe
Device: Dental Loupe
Magnification aid
Active Comparator: with dental operation microscope
Dental caries treatment with dental operation microscope
Device: Dental Operation Microscope
Magnification aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Restoration Success using FDI Criteria
Time Frame: a week after dental treatment
FDI criteria were categorized into three groups [3]: esthetic (four criteria), functional (three criteria) and biological (one criterion) parameters
a week after dental treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

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)

October 1, 2021

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

July 16, 2023

First Submitted That Met QC Criteria

July 16, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 16, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ipek001

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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