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| Name | Class |
|---|---|
| Cairo University | OTHER |
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To assess post operative pain and survival rate after collagen based pulpotomy versus MTA pulpotomy in children with vital primary molars.
Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration using mineral trioxide aggregate of the remaining pulp tissue have been utilized to date. The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promote the healing of the root pulp and be compatible with the physiological process of root resorption.
Collagen, which is available for dental implication, is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contaminations. The collagen particles can be sterilized by various methods like irradiation, dry heat, and ethylene oxide, among which irradiation is the most frequently used method as it does not affect the structural stability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen based pulpotomy | Active Comparator | Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet. Group I collagen-based Pulpotomy:
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| MTA based pulpotomy | Active Comparator | Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet. Group II MTA pulpotomy:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTA based pulpotomy | Other | The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A&B will be at the same patient. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | postoperative pain following the placement of restoration by questioning the patient. using numerical pain rating scale Zero means patient have no pain, while 10 represents the most intense pain possible. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of internal root resorption | binary outcome detected with periapical x-ray by parallel technique using XCP film holder | up to 24 week |
| absence of swelling | binary outcome detected with periapical x-ray by parallel technique using XCP film holder |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherouk Elsayed, bachelor | Contact | +201005544373 | sherouk.elsayed@dentistry.cu.edu.eg | |
| passant nagi, lecturer | Contact | +201280557107 | passant.nagi@dentistry.cu.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34393127 | Background | Anandan V, Inbanathan J, Saket P, Krishnamoorthy V, Gandhi S, Chandrababu VK. Assessment of Clinical and Radiographic Success Rate of Formocresol-based Pulpotomy versus Collagen-based Pulpotomy: An In Vivo Study. J Contemp Dent Pract. 2021 Jun 1;22(6):680-685. |
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Teeth that will be included in the current trial will be randomly assigned one of the experimental groups using closed white envelopes (simple randomization 1:1 ratio).
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the blinding is not possible (unfortunately) due to the nature of the trial. Trial participants, outcome assessors and statistician will be blinded.
| Collagen based pulpotomy | Other | The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A&B will be at the same patient. |
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| up to 24 week |