Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive (A Randomized Controlled Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in pain sensitivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Filtek Bulk Fill posterior composite
Intervention: Bulk Fill Composite (Other)
Cention N without adhesive.
Intervention: Cention N (Other)
Cention N with adhesive
Intervention: Cention N + Adhesive (Other)
Outcomes
Primary Outcomes
Change in pain sensitivity
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University