Pulpotomy Clinical Trial
Official title:
Biodentine Partial Pulpotomy of Pulpally Exposed Primary Molars
Verified date | March 2018 |
Source | Hadassah Medical Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: To compare success rates of biodentine partial pulpotomy versus formocresol
pulpotomy treatment of pulpally exposed lower primary molars.
After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated
to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained,
an assistant drew lots to randomly allocate the case to either the biodentine partial
pulpotomy (PP) or the formocresol pulpotomy (FP) group.
The follow-up for clinical and radiographic evaluation will be carried out at 6-month
intervals.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2020 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 7 Years |
Eligibility |
Inclusion Criteria: - The clinical criteria: primary molar with a deep carious lesion - Sufficient tooth structure for restoration with a stainless steel crown - No history of spontaneous pain - Tenderness to percussion or abnormal mobility - Abscess, fistula, or swelling of the gingiva, and with cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated. - The radiographic criteria: a deep carious lesion in close proximity to the pulp without furcation or radicular pathology - Obliteration of the pulp and root canal, or internal or external root resorption. - Physiologic root resorption, while included in the criteria, could not be more than one-third of the root length. Exclusion Criteria: - The clinical criteria: history of spontaneous pain - Tenderness to percussion or abnormal mobility - Abscess, fistula, or swelling of the gingiva, no cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated. - The radiographic criteria: tooth with furcation or radicular pathology - Obliteration of the pulp and root canal, or internal or external root resorption. - Physiologic root resorption more than one-third of the root length. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | partial pulpotomy clinical success rate | Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure. | 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months | |
Primary | partial pulpotomy radiographic success rate | For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. | 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months | |
Secondary | Formocresol pulpotomy clinical success rate | Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure. | 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months | |
Secondary | Formocresol pulpotomy radiographic success rate | For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. | 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months |
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