Clinical Performance and Antibacterial Effect of Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars

Noha Fouad

Status

Not yet enrolling

Conditions

Healthy Children

Treatments

Other: Stainless steel crown

Other: Cention Forte alkasite bioactive restorative material

Study type

Interventional

Funder types

Other

Identifiers

NCT07094854

Noha Fouad

Details and patient eligibility

About

The study aims to evaluate the clinical performance of Cention-Forte (CF) material in the restoration of pulpotomized second primary molars compared to conventional stainless steel crowns (SSC), and also to assess the restorations' antibacterial effect on salivary cariogenic bacterial count.

Full description

A two-arm randomized controlled clinical trial. A total of 40 healthy cooperative children aged 5-9 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Each child selected will have second primary molar with occluso-proximal carious lesions indicated for pulpotomy. Written informed consent will be obtained from their guardians. After the MTA pulpotomy procedure, participants will be randomly allocated into two groups according to the restoration used. Group I (test group n=20) will receive Cention Forte material, while group II (control group n=20) will receive conventional SSC. Using Modified Ryge's Criteria, the clinical performance of the restorations will be evaluated at 1 week and then after 3, 6 and 12 months for marginal adaptation, proximal contact, retention, gross fracture, occlusal wear, surface roughness and secondary caries. Periapical radiographs will be taken at baseline and after 6 and 12 months. Also, the antibacterial effect of the restorations on salivary cariogenic bacterial count will be assessed at baseline and after 1 week, 1 month and 3 months. Plaque and Gingival index scores as well as parental and child's satisfaction will be recorded.

Data will be collected, tabulated, and statistically analysed to obtain the results and conclusions of this study.

Enrollment

40 estimated patients

Sex

All

Ages

5 to 9 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cooperative children (Positive or definitely positive) according to the Frankl's behaviour rating scale.
Children free of any systemic disease or special health care needs (ASA1).
Completion of an informed consent to participate in the study.
Second primary molar tooth with occluso-proximal carious lesions indicated for pulpotomy.
Restorable tooth.
Radiographically at least two-thirds of the root length is present.
Presence of neighboring and opposing teeth.

Exclusion criteria

Clinical signs or symptoms of irreversible pulpitis or non- vitality.
Radiographic signs of degeneration including internal or external root resorption, furcation involvement.
Pathologic mobility detected by placing the points of a pair of tweezers in the occlusal fossa and gently rocking the tooth buccolingually.
Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes within the last 2 weeks.
Child with parafunctional habits.