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

Dental Restoration Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06273410
• Other study ID #: 0453-6/2022
• Status: Completed
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: November 28, 2023

Study information

• Verified date: February 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 28, 2023
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Restoration Failure

Intervention

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
• 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
• 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.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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