Dental Caries Clinical Trial
Official title:
Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors: Prospective Single Arm Study
NCT number | NCT04758221 |
Other study ID # | 41720 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | July 2020 |
Verified date | February 2021 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective single arm study was to evaluate the clinical success and/ or failure of resin-bonded composite coronal build-up retained by macro-retentive grooves for restoring mutilated primary maxillary incisors after 36 months. Design: Forty two primary incisors out of 14 children, aged 2-5years, treated in a private pediatric dental practice under general anesthesia and presented for follow-up after 6, 12, 18, 24 and 36 months included in the study. The parameters recorded at the baseline and at the follow-up intervals were: retention, colour match, the number and location of the decayed surfaces (recurrent caries), chipping /fracture of the restoration and loss of restoration (failure). Materials and Methods: A total of (14) pediatric patients aged from 2-5 years presented with mutilated primary anterior teeth due to caries or trauma and treated comprehensively under general anesthesia from June 2016 to June 2017 were enrolled in this study. A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micro-mechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth. The patients returned at the end of 6, 12, 18, 24 and 36 months and received clinical examinations. Another dentist (co-author) who did not attend the treatment evaluated the strip crowns clinically by modified United States Public Health Service (USPHS) criteria.
Status | Completed |
Enrollment | 14 |
Est. completion date | July 2020 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 5 Years |
Eligibility | Inclusion Criteria: - Only children in the age group of 2-5 years. - Teeth affected due to caries or trauma with one or two or three surfaces affected or more. Exclusion Criteria: - • Any tooth nearing exfoliation or not fit for restoration. - Patients with systemic problems which may interfere with general anesthesia. - Teeth with excessive pathologic mobility. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the clinical performance of composite strip crowns. | Evaluation of the clinical performance of composite strip crowns. By Clinical photographs. | 36 months | |
Secondary | Assessment of success and failure of the composite coronal build-up after 3 years follow-up. | Assessment of success and failure of the composite coronal build-up after 3 years follow-up in terms of:
Retention Color match Recurrent Caries Fracture/Chipping Loss of restoration (Failure) |
36 months |
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