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

Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive (A Randomized Controlled Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Dental Restoration Failure
• Intervention / Treatment: Other: Cention N; Other: Cention N + Adhesive; Other: Bulk Fill Composite

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cention N without adhesive.	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
Experimental: Cention N with adhesive	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
Active Comparator: Filtek Bulk Fill posterior composite	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain sensitivity	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	1 week, after 3, 6 and 12 months
Change in occurrence of recurrent caries	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.	1 week, after 3, 6 and 12 months
Change in occurrence of marginal stains	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	1 week, after 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): November 28, 2023
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 0453-6/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No