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A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth.
Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biodentine | Experimental | Pulpotomy using Biodentine as pulpotomy medicine. |
|
| White Mineral trioxide Aggregate (MTA) | Active Comparator | Pulpotomy using white MTA as pulpotomy medicine. |
|
| Tempophore | Active Comparator | Pulpotomy using Tempophore as pulpotomy medicine in a control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodentine pulpotomy | Drug |
| ||
| White MTA pulpotomy |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical successes after pulpotomy. | clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility. | at baseline visit |
| Clinical success after pulpotomy. | clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility. | 3 months after pulpotomy. |
| Clinical successes after pulpotomy. | Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility. | 6 months after pulpotomy. |
| Clinical successes after pulpotomy. | Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility. | 12 months after pulpotomy. |
| Radiographic successes after pulpotomy. | Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura. | at baseline visit |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luc Martens, PhD, DDS | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
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|
| Tempophore pulpotomy | Drug |
|
| Radiographic successes after pulpotomy. |
Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura. |
| 6 months after pulpotomy. |
| Radiographic successes after pulpotomy. | Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura. | 12 months after pulpotomy. |