Clinical Evaluation of Different Universal Adhesive Systems in Non-carious Cervical Lesions.

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2022-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to compare the performance of universal adhesives containing different-solvent-based in the restoration of non-carious cervical lesions (NCCLs).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Artificial Intelligence Assisted Spine Rehabilitation in Cervical Disc Herniation

NCT06632028

Herniated Intervertebral Disc

COMPLETED NA

Using Mobile Application for Rehabilitation in Patients With Chronic Neck Pain

NCT05284630

Neck Pain Chronic Pain

COMPLETED NA

Investigation of the Relationship Between Core Stability and Reaction Time, Hand-Eye Coordination, Pain, and Functional Status in Individuals With Rotator Cuff Lesions

NCT07089628

Core Stability Core Stabilization Reaction Time +2 more

RECRUITING

EMG Response in Forearm and Neck Muscles When Comparing Surgical Techniques.

NCT06978309

Surgical Fatigue

COMPLETED

Convolutional Neural Network for the Detection of Cervical Myelomalacia

NCT04796987

Cervical Myelopathy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study was approved by the Ethics Committee of the Istanbul University Faculty of Dentistry in accordance with protocol no. 2019/37-Rev/2. All participants will be informed about the study and will sign the written informed consent prior to the first treatment.

The tested materials are the universal adhesive systems: Single Bond Universal (3M ESPE, St. Paul, MN, USA) and G-Premio Bond (GC Corporation, Tokyo, Japan). Both adhesive systems will be used in selective-etch approach. All restorations will replaced by a single experienced dentist. In this study PASS 11 Software was used to calculate the sample size. At least 230 restorations (n=115) will be included for this study.

The patients will be given local anesthesia if required to prevent discomfort during the intervention. Prior to the restorative procedure the teeth will be cleaned with a pumice water slurry, using a rubber cup. The walls of the lesions are gently and superficially roughened using a round coarse diamond bur before adhesive procedures. Isolation of the tooth will be achieved by the use of cotton rolls and a saliva aspirator, a retraction cord (Ultrapak, Ultradent Products, Inc., South Jordan, USA). Both adhesives will be applied in manufacturer' s instructions with random order, by which the first randomly selected adhesive will be used to restore the tooth with the lowest tooth number (according to the FDI system), and the alternative adhesive will be used for the tooth with the second lowest tooth number. This method will be used for every other tooth requiring a cervical restoration. After adhesive procedures, resin composite will be placed and each increment light cured for 20 seconds (Elipar S10, 3M ESPE, St.Paul, MN, USA). The restorations are then finished and polished.

Restorations will be assessed 7 days after placement (baseline) and after 6, 12, 18, and 24months. Clinical examination will be performed by two blinded examiners, who were not involved in the treatments. Each restoration will be evaluated clinically using a dental loupe according to FDI World Dental Federation criteria. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5.

Esthetic properties: Surface lustre, surface staining, marginal staining, color match and translucency, esthetical anatomical form

Functional properties: Fracture of material and retention, marginal adaptation, wear, approximal anatomical form, patient's view.

Biological properties: Post-operative sensitivity, recurrence of caries, erosion, abfraction, tooth integrity, periodontal response, adjacent mucosa, oral and general health.

Statistical analysis will be performed using IBM SPSS V23 Software. The data is analyzed with Chi- Square, Friedman Test, Bonferroni Test adjustment, Wilcoxon Tests (p \< 0.05).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-carious Cervical Lesions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Single Bond Universal

Single Bond Universal adhesive system with selective-etch approach following the manufacturer's instruction

Group Type EXPERIMENTAL

Single Bond Universal

Intervention Type DEVICE

Adhesive system

Group G-Premio Bond

G-Premio Bond Adhesive System with selective-etch approach following the manufacturer's instruction

Group Type EXPERIMENTAL

G-Premio Bond

Intervention Type DEVICE

Adhesive system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Single Bond Universal

Adhesive system

Intervention Type DEVICE

G-Premio Bond

Adhesive system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participant age should be 18-65 years.
* Good general health condition
* Good oral hygiene
* Should have at least 4 noncarious cervical lesion
* Must not have rampant caries
* At least 20 teeth in occlusion

Exclusion Criteria

* Serious medical problems, allergies to product ingredients
* Poor oral hygiene
* Severe periodontal problems
* Caries or restorative treatment on teeth included in the study
* Parafunctional behavior
* Abutment of tested teeth to a removable prosthesis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes