Clinical Evaluation of Two Low-shrinkage Composites

NCT ID: NCT03708510

Last Updated: 2024-04-17

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

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

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-01

Study Completion Date

2018-09-01

Brief Summary

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

Patients with 4 occlusal lesions in molar teeth will be included. Occlusal cavities will be prepared either by Er,Cr:YSGG laser (LS) or conventional diamond bur (BR). Cavities will be restored with Filtek Silorane (3M-ESPE) (SR) and with Kalore (GC) (KR) according to the manufacturers' instructions. All restorative procedures will be performed by one operator and the restorations will be examined by two evaluators according to the FDI (World Dental Federation) criteria at baseline and at 6-month, 1-, 2-,3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-year. Patients' satisfaction about the preparation methods will be evaluated with a survey. Pearson Chi-Square test will be used for statistical analyze(p=0.05).

Detailed Description

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

Conditions

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

Tooth Diseases

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

Filtek Silorane-Er,Cr:YSGG Laser

Group Type EXPERIMENTAL

Restorative materials- Filtek Silorane

Intervention Type DEVICE

Filtek Silorane

Preparation-Er,Cr:YSGG Laser

Intervention Type DEVICE

Er,Cr:YSGG Laser

Filtek Silorane- Diamond Bur

Group Type EXPERIMENTAL

Restorative materials- Filtek Silorane

Intervention Type DEVICE

Filtek Silorane

Preparation- Diamond Bur

Intervention Type DEVICE

Bur

Kalore- Er,Cr:YSGG Laser

Group Type EXPERIMENTAL

Restorative materials-Kalore

Intervention Type DEVICE

Kalore

Preparation-Er,Cr:YSGG Laser

Intervention Type DEVICE

Er,Cr:YSGG Laser

Kalore- Diamond Bur

Group Type EXPERIMENTAL

Restorative materials-Kalore

Intervention Type DEVICE

Kalore

Preparation- Diamond Bur

Intervention Type DEVICE

Bur

Interventions

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

Restorative materials- Filtek Silorane

Filtek Silorane

Intervention Type DEVICE

Restorative materials-Kalore

Kalore

Intervention Type DEVICE

Preparation-Er,Cr:YSGG Laser

Er,Cr:YSGG Laser

Intervention Type DEVICE

Preparation- Diamond Bur

Bur

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

1. age range will be 18 to 60
2. patients should have at least 4 occlusal caries lesions require restoration
3. healty periodontal status
4. a good likelihood of recall availability

Exclusion Criteria

1. poor gingival health
2. adverse medical history
3. potential behavioral problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Fatma Dilşad Öz

Doctor, DDS, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Kalore-Silorane, Laser-Bur

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.