Evaluation of Clinical Success of Restorations Using Different Magnification Aids

NCT ID: NCT05959382

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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with no magnification aid treatment

Dental caries treatment with no magnification aid

Group Type NO_INTERVENTION

No interventions assigned to this group

with x2 dental loupe

Dental caries treatment with x2 dental loupe

Group Type ACTIVE_COMPARATOR

Dental Loupe

Intervention Type DEVICE

Magnification aid

with x5 dental loupe

Dental caries treatment with x5 dental loupe

Group Type ACTIVE_COMPARATOR

Dental Loupe

Intervention Type DEVICE

Magnification aid

with dental operation microscope

Dental caries treatment with dental operation microscope

Group Type ACTIVE_COMPARATOR

Dental Operation Microscope

Intervention Type DEVICE

Magnification aid

Interventions

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Dental Loupe

Magnification aid

Intervention Type DEVICE

Dental Operation Microscope

Magnification aid

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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ipek çubukçu

Ipek Cubukcu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ataturk University

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ipek001

Identifier Type: -

Identifier Source: org_study_id

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