NCT06543680

Brief Summary

To evaluate and compare two-year clinical performance of commercially available resin modified glass ionomer cement, self-adhesive composite hybrid and self-adhesive flowable composite restorative materials for non-carious cervical lesions

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

August 4, 2024

Last Update Submit

August 4, 2024

Conditions

Secondary Caries Dental Restoration Failure of Marginal Integrity

Outcome Measures

Primary Outcomes (1)

  • Percentage of aesthetic, functional and biological properties for each group

    Percentage of aesthetic, functional and biological properties that will be clinically assessed using World Dental Federation and USPHS parameters for each restorative system group

    2 years after restoration

Study Arms (3)

Resin Modified Glass Ionomer cement

ACTIVE COMPARATOR

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Other: Dental restoration

Self-Adhesive flowable composite

PLACEBO COMPARATOR

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Other: Dental restoration

Self-Adhesive composite hybrid

PLACEBO COMPARATOR

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Other: Dental restoration

Interventions

Dental restorationOTHER

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Resin Modified Glass Ionomer cementSelf-Adhesive composite hybridSelf-Adhesive flowable composite

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry mansoura university

Al Mansurah, Dakahliya, 35516, Egypt

RECRUITING

Study Officials

  • Mohamed E Hamouda, Assistant Lecturer

    Faculty of Dentistry, Mansoura University, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed E Hamouda, Assistant Lecturer

CONTACT

01018357630mohamedelbahloul@mans.edu.eg

Abeer E Elembaby, Professor

CONTACT

01000033812ab_elembaby@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized clinical trial will be performed. A number of 35 patients will be included in this study. Each patient will have at least three NCCLs. One of these lesions will be randomly restored with resin modified glass ionomer cement, the second lesion will be restored with self-adhesive Surefil One composite hybrid while the third lesion will be restored with self-adhesive flowable composite.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

August 4, 2024

First Posted

August 9, 2024

Study Start

May 29, 2023

Primary Completion

May 29, 2025

Study Completion

May 31, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available within 6 Months for 2 years
Access Criteria
For any one

Locations

EG(1)