Evaluation of Clinical Success of Restorations Using Different Magnification Aids

• Sponsor: Ataturk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05959382
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 4
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Device: Dental Loupe; Device: Dental Operation Microscope	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: It has 4 groups in total. The treatments were carried out with no magnification aid with x2 loupe with x5 loupe with Dental operation microscopeIt has 4 groups in total. The treatments were carried out with no magnification aid with x2 loupe with x5 loupe with Dental operation microscope
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Clinical Success of Restorations Using Different Magnification Aids
• Actual Study Start Date: Oct 1, 2021
• Actual Primary Completion Date: Dec 20, 2021
• Actual Study Completion Date: Dec 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Evaluation of Restoration Success using FDI Criteria [a week after dental treatment]

   FDI criteria were categorized into three groups [3]: esthetic (four criteria), functional (three criteria) and biological (one criterion) parameters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ataturk University	Erzurum		Turkey	25080

Sponsors and Collaborators

• Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ipek çubukçu, Ipek Cubukcu, Ataturk University
• ClinicalTrials.gov Identifier: NCT05959382
• Other Study ID Numbers: ipek001
• First Posted: Jul 25, 2023
• Last Update Posted: Jul 25, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ipek çubukçu, Ipek Cubukcu, Ataturk University: dental loupe; restoration success; FDI criteria
• Additional relevant MeSH terms: Dental Caries

Study Results

No Results Posted as of Jul 25, 2023