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

Not Applicable

Completed

• Conditions: Dental Restoration Failure
• Interventions: Other: Cention N + Adhesive; Other: Bulk Fill Composite; Other: Cention N

• Registration Number: NCT06273410
• Lead Sponsor: Hams Hamed Abdelrahman

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-13
• Primary Completion: 2023-11-28
• Study Completion: 2023-11-28
• Status Verified: 2024-02
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-14
• Last Update Submitted: 2024-02-14
• Study First Posted: 2024-02-22
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cention N with adhesive	Cention N + Adhesive	-
Filtek Bulk Fill posterior composite	Bulk Fill Composite	-
Cention N without adhesive.	Cention N	-

Primary Outcome Measures

Name	Time	Method
Change in pain sensitivity	1 week, after 3, 6 and 12 months	Air spray will be applied from a 2-mm distance on to the occlusal surface for 35seconds and should always be compared with the reaction of adjacent vital teeth. The severity of patients' pain/sensitivity will be recorded and given a score from 1 to 5
Change in occurrence of marginal stains	1 week, after 3, 6 and 12 months	It is recommended to ask the patient about dietary habits. The restoration surface will be evaluated with regard to staining by comparison with the surrounding hard tissues and will be performed by the means of visual inspection aided with intraoral photography
Change in occurrence of recurrent caries	1 week, after 3, 6 and 12 months	All surfaces were dried prior to evaluation. The restorations' assessment will be performed using a dental mirror and a ball-point probe aided by periapical radiographs.

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt