Pulp Disease, Dental Clinical Trial
Official title:
Clinical and Radiographic Evaluation of Biodentine Versus Formocresol in Vital Pulpotomy of Primary Molars: (A Randomized Control Clinical Trial)
Verified date | June 2018 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim of the study: To compare Formocresol and Biodentine clinically and radiographically when used for pulpotomy of primary molars Study Design : A randomized control clinical trial (split mouth and double blind) was conducted on 43 (4-6 years-old) children with decayed vital mandibular primary molars which were treated by pulpotomy using both medicaments . All treated teeth were followed for one year (at 3, 6, 9 and 12 months clinically and at 6 and 9 radiographically).
Status | Completed |
Enrollment | 43 |
Est. completion date | February 22, 2018 |
Est. primary completion date | January 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 6 Years |
Eligibility |
Inclusion Criteria: - Healthy children between 4 and 6 years of age with two matched bilateral deep carious primary mandibular first or second molars. - No evident clinical symptoms of pulpal necrosis or pulp degeneration such as pain on percussion, spontaneous pain, history of swelling or presence of sinus tract. - No pathologic or physiologic mobility. - No radiographic evidence of internal and external resorption, pulp stone, and interradicular or periapical lesions (Preoperative radiograph). - The remaining tooth structure would be restorable with a stainless steel crown. - Bleeding time after amputation of the coronal pulp tissue was within normal limits (5 minutes). Exclusion Criteria: - Bleeding time after amputation of the coronal pulp tissue exceed normal limits (5 minutes). |
Country | Name | City | State |
---|---|---|---|
Egypt | Adel Elbardissy | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessing survival rate regarding absence of spontaneous pain over time. using a questionnaire. | measurement of survival rate regarding absence of spontaneous pain and assessing the change over time ( binary outcome measured by direct questioning to the patient. | 3,6,9 and12 months. | |
Secondary | Assessing absence of abscess, fistula or pathologic mobility over time using visual and clinical examination. | Absence of abscess, fistula or pathologic mobility ( binary outcome measured by visual and clinical examination). | 3, 6, 9 and 12 months. | |
Secondary | Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ). | Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ) with assessment of change over time. | 6 and 12 months. | |
Secondary | Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) . | Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) with assessment of change over time. | 6 and 12 months | |
Secondary | Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) . | Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) with assessment of change over time. | 6 and 12 months |
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