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Completed

NCT Number: NCT05959382

Evaluation of Clinical Success of Restorations Using Different Magnification Aids

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental Loupe

Device

Magnification aid

Dental Operation Microscope

Device

Magnification aid

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 25, 2023
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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