A 2-year Clinical Performance of Two Different Ion-releasing Bulk-fill Restorative Materials Posterior Cavities
Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05952609
Collaborator
(none)
32
1
3
27.1
1.2
Study Details
Study Description
Brief Summary
The aim of this study is to evaluate and compare the clinical performance of 2 ion-releasing bulk-fill restorative materials in comparison with a bulk-fill resin composite restoration in posterior cavities.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 2-year Clinical Performance of Two Different Ion-releasing Bulk-fill Restorative Materials Placed in Posterior Cavities
Actual Study Start Date
:
Feb 10, 2021
Actual Primary Completion Date
:
Apr 15, 2023
Actual Study Completion Date
:
May 15, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 Patients receiving Surefil One |
Other: Surefil One
Ion-releasing restoration
|
| Experimental: Group 2 Patients receiving Cention N |
Other: Cention N
Ion-releasing restoration
|
| Active Comparator: Group 3 Patients receiving bulkfil resin composite |
Other: Bulkfil resin composite
resin composite (No ion-release)
|
Outcome Measures
Primary Outcome Measures
- Evaluating surface and marginal staining [2 years]
FDI criteria will be used
- Evaluating fracture and retention of the materials [2-years]
FDI criteria will be used
- Evaluating marginal adaptation and discoloration of the materials [2-years]
FDI criteria will be used
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Criteria for patient's inclusion in the study will be the presence of at least 3 occlusal or proximal carious lesion in posterior teeth, favourable and stable occlusion between the remaining teeth, the patients must be older than 18 years old with permanent dentition, moderate oral hygiene, asymptomatic vital teeth with no sensitivity to percussion, and the presence of contact with adjacent teeth
Exclusion Criteria:
- Exclusion criteria will be, sever bruxism, patients with known unavailability to attend recall visits, patients with known allergy to any component of the study materials, pulp exposure during caries excavation, patients with unstable medical conditions and pregnant or lactating individuals.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mansoura University | Mansoura | Dakahlyia | Egypt | 35511 |
Sponsors and Collaborators
- Mansoura University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT05952609
Other Study ID Numbers:
- M02060421
First Posted:
Jul 19, 2023
Last Update Posted:
Jul 19, 2023
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No