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

NCT06273410 | Completed

• 1 other identifier: 0453-6/2022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Restoration Failure

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Cention N without adhesive.

EXPERIMENTAL

Other: Cention N

Cention N with adhesive

EXPERIMENTAL

Other: Cention N + Adhesive

Filtek Bulk Fill posterior composite

ACTIVE COMPARATOR

Other: Bulk Fill Composite

Interventions

Cention N 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 without adhesive.

Cention N + Adhesive 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

Cention N with adhesive

Bulk Fill Composite 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40229532 DERIVED

MeSH Terms

Interventions

Adhesives

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 22, 2024
• Study Start: October 13, 2022
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

EG (1)