Clinical Evaluation of a Bioactive Material

Sponsor

Hacettepe University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04825379

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The clinical performance of a bioactive composite and a posterior resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a bioactive composite [Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)] and a posterior resin composite [G-ænial Posterior (GC, Tokyo, Japan) (GP)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

Condition or Disease	Intervention/Treatment	Phase
Tooth Disease	Device: bioactive composite Device: posterior composite	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Clinical Evaluation of a Bioactive Material

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bioactive composite Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)	Device: bioactive composite Cention N
Experimental: posterior resin composite G-ænial Posterior (GC, Tokyo, Japan) (GP)	Device: posterior composite G-ænial Posterior

Arm

Intervention/Treatment

Experimental: bioactive composite

Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)

Device: bioactive composite

Cention N

Experimental: posterior resin composite

G-ænial Posterior (GC, Tokyo, Japan) (GP)

Device: posterior composite

G-ænial Posterior

Outcome Measures

Primary Outcome Measures

Clinical performances of different restorative systems according to FDI criteria [two years]
Two year results according to FDI criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age range will be 18 to 65
patients should have at least 2 approximal caries lesions require restoration
healthy periodontal status
a good likelihood of recall availability

Exclusion Criteria:

poor gingival health
adverse medical history
potential behavioral problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey

Sponsors and Collaborators

Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Fatma Dilşad Öz, Assoc. Prof. Dr., Hacettepe University

ClinicalTrials.gov Identifier:

NCT04825379

Other Study ID Numbers:

bioactive-composite

First Posted:

Apr 1, 2021

Last Update Posted:

Dec 15, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tooth Diseases

Study Results

No Results Posted as of Dec 15, 2021