Evaluation of Clinical Success of Restorations Using Different Magnification Aids

Dental Caries Clinical Trial

Official title:

Evaluation of Clinical Success of Restorations Using Different Magnification Aids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05959382
• Other study ID #: ipek001
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 30, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Dental Loupe
Magnification aid
• Dental Operation Microscope
Magnification aid

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

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