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NCT Number: NCT07094854

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

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.

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Key information

Conditions

Healthy Children

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University, Alexandria, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cention Forte alkasite bioactive restorative material

Other

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

Stainless steel crown

Other

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

Primary outcomes

  1. Clinical performance of the restorations using Modified Ryge's Criteria

    Time frame: One year

    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

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

    Time frame: 3 months

    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.

Secondary outcomes

  1. Radiographic success of pulpotomized second primary molars in both groups

    Time frame: One year

    The success of pulpotomy procedure will be assessed radiographically using digital periapical xray after 6 and 12 months.

  2. Gingival index

    Time frame: One year

    Gingival health will be assessed clinically at baseline, then after 3, 6 and 12 months using the gingival index score:

    Scores for the index indicate:

    0: normal gingival

    • mild inflammation, sllight change in colour and slight edema. No bleeding on probing
    • Moderate inflammation: redness, edema and glazing. Bleeding on probing.
    • Severe inflammation: marked redness, edema and ulcerations. Tendency towards spontaneous bleeding

  3. Plaque index

    Time frame: One year

    Gingival health will be assessed clinically using plaque index at baseline, then after 3, 6 and 12 months.

    Plaque index scores indicate:

    0: No plaque

    • A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in-situ only after application of disclosing solution or by using the probe on the tooth surface
    • Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen by the naked eye
    • Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  4. Child satisfaction

    Time frame: Over one year

    The patient's perception of the treatment will be assessed by using the Facial Image Scale (FIS) that represents satisfaction, indifference, or dissatisfaction. A few minutes will be spent before each procedure to establish rapport with the child and to obtain some notion of the child's understanding of the meaning of those schematic facial expressions. After treatment, the child will be instructed to choose the face that best represented how he/she felt during the procedure.

  5. Parental satisfaction

    Time frame: Over one year

    Parental satisfaction level will be assessed immediately after the procedure with 5-point Likert scale where 1-very dissatisfied; 2-dissatisfied; 3-neutrally satisfied; 4-satisfied; 5-very satisfied. Parents will be asked to rate their satisfaction regarding appearance, color, size, durability, and overall satisfaction for the restoration/crown.

Study contacts

Contact information is provided by the study sponsor or research team.

Magda M ElTekeya, Prof

CONTACT

[email protected]

00201122299960

Noha F Saleh, PhD

CONTACT

[email protected]

00201091919597

Sponsors and collaborators

Lead sponsor

Noha Fouad

Other

Registry information

Official study title

Clinical Performance and Antibacterial Effect of a Bulk Fill Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars(Randomized Controlled Clinical Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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