Evaluation of Clinical Success of Restorations Using Different Magnification Aids

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Dental Loupe

Dental Operation Microscope

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring dental loupe, restoration success, FDI criteria

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Arm Label

with no magnification aid treatment

with x2 dental loupe

with x5 dental loupe

with dental operation microscope

Arm Description

Dental caries treatment with no magnification aid

Dental caries treatment with x2 dental loupe

Dental caries treatment with x5 dental loupe

Dental caries treatment with dental operation microscope

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05959382

First Posted

July 16, 2023

Last Updated

July 16, 2023

Sponsor

Ataturk University

1. Study Identification

Unique Protocol Identification Number

NCT05959382

Brief Title

Evaluation of Clinical Success of Restorations Using Different Magnification Aids

Official Title

Evaluation of Clinical Success of Restorations Using Different Magnification Aids

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

December 20, 2021 (Actual)

Study Completion Date

December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

dental loupe, restoration success, FDI criteria

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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 microscope

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

with no magnification aid treatment

Arm Type

No Intervention

Arm Description

Dental caries treatment with no magnification aid

Arm Title

with x2 dental loupe

Arm Type

Active Comparator

Arm Description

Dental caries treatment with x2 dental loupe

Arm Title

with x5 dental loupe

Arm Type

Active Comparator

Arm Description

Dental caries treatment with x5 dental loupe

Arm Title

with dental operation microscope

Arm Type

Active Comparator

Arm Description

Dental caries treatment with dental operation microscope

Intervention Type

Device

Intervention Name(s)

Dental Loupe

Intervention Description

Magnification aid

Intervention Type

Device

Intervention Name(s)

Dental Operation Microscope

Intervention Description

Magnification aid

Primary Outcome Measure Information:

Title

Evaluation of Restoration Success using FDI Criteria

Description

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

Time Frame

a week after dental treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Ataturk University

City

Erzurum

ZIP/Postal Code

25080

Country

Turkey

Dental Caries

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial