Efficiency of Different Modes of Universal Adhesive

Hacettepe University

Status: Active, not recruiting

Conditions: Adhesion; Dental Caries

Treatments: Device: Self-etch; Device: Total-etch

Study type: Interventional

Funder types: Other

Identifiers

NCT04271150

KA-180016

Details and patient eligibility

About

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

Full description

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Self-etch

Experimental group

Description:

Self-etch mode of the universal adhesive will be used

Treatment:

Device: Self-etch

Total-etch

Active Comparator group

Description:

Total etch mode of the universal adhesive will be used

Treatment:

Device: Total-etch