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

NCT ID: NCT06273410

Last Updated: 2024-02-22

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-13

Study Completion Date

2023-11-28

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Restoration Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cention N without adhesive.

Group Type EXPERIMENTAL

Cention N

Intervention Type OTHER

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

Cention N with adhesive

Group Type EXPERIMENTAL

Cention N + Adhesive

Intervention Type OTHER

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

Filtek Bulk Fill posterior composite

Group Type ACTIVE_COMPARATOR

Bulk Fill Composite

Intervention Type OTHER

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.

Interventions

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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

Intervention Type 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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Permanent molars with occlusal pit and fissure caries.
* Good oral hygiene.
* Occlusal contact with antagonist teeth.

Exclusion Criteria

* Permanent molars with occlusal pit and fissure caries.
* Good oral hygiene.
* Age between 18- 45 years.
* Occlusal contact with antagonist teeth.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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El-Salamouny NA, Elmahy WA, Holiel AA. Comparative evaluation of bioactive alkasite-based material in different application modes: a 1-year randomized controlled clinical trial. Odontology. 2025 Oct;113(4):1689-1700. doi: 10.1007/s10266-025-01095-4. Epub 2025 Apr 15.

Reference Type DERIVED
PMID: 40229532 (View on PubMed)

Other Identifiers

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0453-6/2022

Identifier Type: -

Identifier Source: org_study_id

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