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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cention forte material | Experimental |
| |
| Stainless steel crown | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cention Forte alkasite bioactive restorative material | Other | Cention forte material will be used as a final restoration for pulpotomized second primary molars |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| Gingival index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noha F Saleh, PhD | Contact | 00201091919597 | Dr.nohafouad.93@gmail.com | |
| Magda M ElTekeya, Prof | Contact | 00201122299960 | Magdatekeya@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Magda M ElTekeya | Alexandria University | Study Director |
| Niveen S Bakry | Alexandria University | Study Director |
| Azza Zakaria |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | Egypt | ||||
| Faculty of Pharmacy, Alexandria University |
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Outcome assessor, statistician and the microbiologist are blinded
| Stainless steel crown | Other | The control group using the gold standard stainless steel crown (SSC) as a final restoration for pulpotomized second primary molars |
|
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
| 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
| 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. | 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. | Over one year |
| Alexandria University |
| Study Director |
| Alexandria |
| Egypt |