Iatrogenic Perforation of Primary Molars Clinical Trial
Official title:
Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics
| NCT number | NCT04137861 |
| Other study ID # | 308 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 25, 2019 |
| Est. completion date | October 25, 2020 |
| Verified date | February 2021 |
| Source | Minia University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Furcal perforation is one of the most challenging procedural accidents during pulpotomy of primary molars and should be sealed as soon as possible to prevent bacterial invasion at perforation site and subsequent tooth extraction. The aim of the study is to compare bioceramics versus MTA as root repair material for treatment of furcal perforation in primary molars
| Status | Completed |
| Enrollment | 76 |
| Est. completion date | October 25, 2020 |
| Est. primary completion date | August 25, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 4 Years to 7 Years |
| Eligibility | Inclusion Criteria: - Apparently healthy children aged from 4 to 7 years - No history of spontaneous pain or swelling - No signs or symptoms of irreversible pulpits or loss of vitality - Absence of radicular or priapical lesions. - Accidental furcal perforation should be immediate or mediate (within two weeks) perforation in primary molars. Exclusion Criteria: - Children with systemic disease - Presence of priapical lesions |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Minia University | Minya |
| Lead Sponsor | Collaborator |
|---|---|
| Ahmad Elheeny |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | clinical success | Visual oral examination | 9 months | |
| Primary | radiographic success | Radiolucency assessment (+/-) | 9 months |