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Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive

NCT06273410 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-02-22

No results posted yet for this study

Summary

Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Its application in restorative dentistry may be significant, promoting remineralization of carious lesions \& reduction of polymerization shrinkage. The study will aim to compare the clinical performance of Cention N (with and without adhesive) and composite resin (Filtek Bulk Fill) in class I restorations using FDI criteria. Thirty-six class I cavities will be selected and equally allocated into 3 groups: Group I (n=12): (Cention N with adhesive), Group II (n=12): (Cention N without adhesive) \& Group III (n=12): composite resin (Filtek Bulk Fill) in class I cavities. Patients will be followed up at 1 week 3, 6, and 12 months and evaluated using the FDI criteria. Postoperative sensitivity, staining, and recurrent caries will be evaluated in this clinical trial.

Conditions

  • Dental Restoration Failure

Interventions

OTHER

Cention N

Cention N will be manipulated using the standard powder: liquid ratio which is, one scoop of powder with one drop of liquid. Powder and liquid will be dispensed on the mixing pad and mixed using a plastic spatula according to the manufacturer's instruction for 45-60 seconds

OTHER

Cention N + Adhesive

Cavity will be rinsed with water to remove all residue. Etchant will be applied onto the prepared cavity for 15 seconds and thoroughly rinsed with water spray and gently dried with air jet. A layer of Tetric N Bond universal will be applied on the enamel \& dentin surface using a disposable applicator, the material will be gently brushed into dentin for at least 10 seconds

OTHER

Bulk Fill Composite

Cavity will be rinsed with water to remove all residue. Etchant will be applied onto the prepared cavity for 15 seconds and thoroughly rinsed with water spray and gently dried with air jet. A layer of Tetric N Bond universal will be applied on the enamel \& dentin surface using a disposable applicator, the material will be gently brushed into dentin for at least 10 seconds.

Sponsors & Collaborators

  • Hams Hamed Abdelrahman

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2023-11-28
Completion
2023-11-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06273410 on ClinicalTrials.gov