Healthy ChildrenNCT07094854
Clinical Performance and Antibacterial Effect of Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars
A study testing Cention Forte alkasite bioactive restorative material and Stainless steel crown in people with Healthy Children, run by Noha Fouad at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Healthy Children
- What is being tested?
- Cention Forte alkasite bioactive restorative material and Stainless steel crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Faculty of Dentistry, Alexandria University
Alexandria
Faculty of Pharmacy, Alexandria University
Alexandria
About this study
Official title: Clinical Performance and Antibacterial Effect of a Bulk Fill Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars(Randomized Controlled Clinical Trial)
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.
Read the detailed 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.
- Conditions
- Healthy Children
- Being tested
- Cention Forte alkasite bioactive restorative material, Stainless steel crown
- Keywords
- Cention Forte, Alkasite, bioactive, pulpotomy, primary teeth, stainless steel crown, bulk fill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cention Forte alkasite bioactive restorative materialOther
Cention forte material will be used as a final restoration for pulpotomized second primary molars
Stainless steel crownOther
The control group using the gold standard stainless steel crown (SSC) as a final restoration for pulpotomized second primary molars
| Study group | Role | What they receive |
|---|---|---|
| Cention forte material | Experimental | Not described Receives: Other: Cention Forte alkasite bioactive restorative material |
| Stainless steel crown | Active comparator | Not described Receives: Other: Stainless steel crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 months
Secondary outcomes (5)
Radiographic success of pulpotomized second primary molars in both groups
The success of pulpotomy procedure will be assessed radiographically using digital periapical xray after 6 and 12 months.
Measured: One year
Gingival index
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
Measured: One year
Plaque index
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.
Measured: One year
Child satisfaction
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.
Measured: Over one year
Parental satisfaction
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.
Measured: Over one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noha Fouad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Fouad, Alexandria University
- Investigators
- Magda M ElTekeya, Study director, Alexandria UniversityNiveen S Bakry, Study director, Alexandria UniversityAzza Zakaria, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094854
- Sponsor's protocol ID
- Noha Fouad
- Status last verified
- Jul 2025
- First submitted
- 29 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Antibacterial Effect of a Bulk Fill Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars(Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07094854
- Acronym / sponsor ID
- Noha Fouad
- Conditions
- Healthy Children
- Keywords
- Cention Forte, Alkasite, bioactive, pulpotomy, primary teeth, stainless steel crown, bulk fill
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Noha FouadUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cention forte material | Experimental | Other: Cention Forte alkasite bioactive restorative material |
| Stainless steel crown | Active comparator | Other: Stainless steel crown |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cention Forte alkasite bioactive restorative materialCention forte material will be used as a final restoration for pulpotomized second primary molars | Other | Cention forte material |
| Stainless steel crownThe control group using the gold standard stainless steel crown (SSC) as a final restoration for pulpotomized second primary molars | Other | Stainless steel crown |
Primary outcome
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
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.
5 secondary outcomes
Radiographic success of pulpotomized second primary molars in both groups
Time frame: One year
Gingival index
Time frame: One year
Plaque index
Time frame: One year
Child satisfaction
Time frame: Over one year
Parental satisfaction
Time frame: Over one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magda M ElTekeya study director
Alexandria University
Niveen S Bakry study director
Alexandria University
Azza Zakaria study director
Alexandria University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cention Forte alkasite bioactive restorative material and Stainless steel crown in people with Healthy Children, run by Noha Fouad at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha F Saleh, PhD (00201091919597, Dr.nohafouad.93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of the restorations using Modified Ryge's Criteria (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.