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

NCT07094854 | Not Yet Recruiting

• 1 other identifier: Noha Fouad
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Children

Keywords

Cention Forte; Alkasite; bioactive; pulpotomy; primary teeth; stainless steel crown; bulk fill

Outcome Measures

Primary Outcomes (2)

• Clinical performance of the restorations using Modified Ryge's Criteria

  The clinical evaluation of the two restorations will be done using parameters of marginal adaptation, proximal contact, retention, gross fracture, occlusal wear, surface roughness, and secondary caries as per the modified United States Public Health Service (USPHS) Ryge's criteria. Scores for the modified Ryge's criteria are as follow: * alpha: represents the ideal or excellent condition of a restoration * bravo: indicates a clinically acceptable restoration with minor defects * charlie: indicates restoration is unacceptable clinically and should be replaced

  One year

• The antibacterial effect of both restorations on salivary cariogenic bacterial count.

  The saliva samples will be collected to assess microbiological colony count of S.mutan and lactobacilli at baseline, after 1 week, 1 month and 3 months.

  3 months

Secondary Outcomes (5)

• Radiographic success of pulpotomized second primary molars in both groups

  One year

• Gingival index

  One year

• Plaque index

  One year

• Child satisfaction

  Over one year

• Parental satisfaction

  Over one year

Study Arms (2)

Cention forte material

EXPERIMENTAL

Other: Cention Forte alkasite bioactive restorative material

Stainless steel crown

ACTIVE COMPARATOR

Other: Stainless steel crown

Interventions

Cention Forte alkasite bioactive restorative material OTHER

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

Cention forte material

Stainless steel crown OTHER

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

Stainless steel crown

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noha Fouad: lead

Study Sites (2)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Faculty of Pharmacy, Alexandria University

Alexandria, Egypt

Location

Study Officials

• Magda M ElTekeya

  Alexandria University

  STUDY DIRECTOR

• Niveen S Bakry

  Alexandria University

  STUDY DIRECTOR

• Azza Zakaria

  Alexandria University

  STUDY DIRECTOR

Central Study Contacts

Noha F Saleh, PhD

CONTACT

00201091919597; Dr.nohafouad.93@gmail.com

Magda M ElTekeya, Prof

CONTACT

00201122299960; Magdatekeya@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor, statistician and the microbiologist are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of Pediatric Dentistry, Faculty of Dentistry, Alexandria University

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 30, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)