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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioceramic Putty Versus MTA in Pulpotomized Primary Teeth to be Covered With 3D Printed Resin Crowns Versus Stainless Steel Crown

NCT07344038

Caries Active

RECRUITING NA

Flowable Resin Composite: Two-Year Clinical Performance in Class I Restorations

NCT07330193

Class I Dental Caries

COMPLETED NA

Success Rate of Three Capping Materials

NCT03833557

Caries

COMPLETED NA

Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin

NCT04145102

Dentin Caries

COMPLETED NA

Clinical Performance of Milled Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year

NCT04518371

Endodontically Treated Teeth

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessor, statistician and the microbiologist are blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cention forte material

Group Type EXPERIMENTAL

Cention Forte alkasite bioactive restorative material

Intervention Type OTHER

Cention forte material will be used as a final restoration for pulpotomized second primary molars

Stainless steel crown

Group Type ACTIVE_COMPARATOR

Stainless steel crown

Intervention Type OTHER

The control group using the gold standard stainless steel crown (SSC) as a final restoration for pulpotomized second primary molars

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cention Forte alkasite bioactive restorative material

Cention forte material will be used as a final restoration for pulpotomized second primary molars

Intervention Type OTHER

Stainless steel crown

The control group using the gold standard stainless steel crown (SSC) as a final restoration for pulpotomized second primary molars

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No