Evaluation of Clinical Success of Restorations Using Different Magnification Aids

NCT05959382 | Completed

• 1 other identifier: ipek001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

dental loupe; restoration success; FDI criteria

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

with no magnification aid treatment

NO INTERVENTION

Dental caries treatment with no magnification aid

with x2 dental loupe

ACTIVE COMPARATOR

Dental caries treatment with x2 dental loupe

Device: Dental Loupe

with x5 dental loupe

ACTIVE COMPARATOR

Dental caries treatment with x5 dental loupe

Device: Dental Loupe

with dental operation microscope

ACTIVE COMPARATOR

Dental caries treatment with dental operation microscope

Device: Dental Operation Microscope

Interventions

Dental Loupe DEVICE

Magnification aid

with x2 dental loupe; with x5 dental loupe

Dental Operation Microscope DEVICE

Magnification aid

with dental operation microscope

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ipek Cubukcu

Model Details: 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

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 25, 2023
• Study Start: October 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 30, 2022
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

TU (1)