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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06273410
Enrollment
36
Registered
2024-02-22
Start date
2022-10-13
Completion date
2023-11-28
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Restoration Failure

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.

Interventions

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

OTHERCention 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

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.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in pain sensitivity1 week, after 3, 6 and 12 monthsAir 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 recurrent caries1 week, after 3, 6 and 12 monthsAll 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.
Change in occurrence of marginal stains1 week, after 3, 6 and 12 monthsIt 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026