Efficiency of Different Modes of Universal Adhesive

NCT ID: NCT04271150

Last Updated: 2020-02-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2025-05-01

Brief Summary

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The purpose of this study is to evaluate and compare the clinical performance of a Universal adhesive's different application modes.

Detailed Description

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Class 2 composite restorations will be placed using a bulk-fill composite resin restorative on two posterior teeth with proximal caries, in a split mouth design. 25 patients will be included in the study. The teeth will be randomized into two groups according to the application mode of universal adhesive material.

Group 1: the universal adhesive will be used in etch-and-rinse mode Group 2: the universal adhesive will be used in self-etch mode. The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of atraumatic resin restorations. The restorations will be evaluated at baseline and 6th, 12th, 18th, 24th months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.

The data will be analysed statistically using Fisher's Exact Test; and the Kaplan-Meier and Wilcoxon method will be used to estimate survival percentages.

Conditions

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Dental Caries Adhesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Self-etch

Self-etch mode of the universal adhesive will be used

Group Type EXPERIMENTAL

Self-etch

Intervention Type DEVICE

Universal adhesive with self-etch mode

Total-etch

Total etch mode of the universal adhesive will be used

Group Type ACTIVE_COMPARATOR

Total-etch

Intervention Type DEVICE

Universal adhesive with total-etch mode

Interventions

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Self-etch

Universal adhesive with self-etch mode

Intervention Type DEVICE

Total-etch

Universal adhesive with total-etch mode

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* a need for at least two but not more than four posterior tooth-colored restorations
* the presence of teeth to be restored in occlusion
* teeth that were symptomless and vital
* a normal periodontal status
* a good likelihood of recall availability.

Exclusion Criteria

* partly erupted teeth
* absence of adjacent and antagonist teeth
* poor periodontal status
* adverse medical history
* potential behavioral problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Bilge Kutuk

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse R Yazici, DDS, PhD

Role: STUDY_DIRECTOR

Hacettepe University School of Dentistry

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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Other Identifiers

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KA-180016

Identifier Type: -

Identifier Source: org_study_id

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