Deep Caries Clinical Trial
Official title:
Clinical and Radiographic Evaluation of Indirect Pulp Treatment of Young Permanent Molars Using Photo-Activated Oral Disinfection Versus Calcium Hydroxide: A Randomized Clinical Trial
NCT number | NCT03631277 |
Other study ID # | pulp capping |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | April 2017 |
Verified date | August 2018 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aimed to assess the clinical and radiographic success for photo-activated oral disinfection (PAD) and calcium hydroxide in indirect pulp treatment (IPT) of young permanent molars.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Restorable lower first permanent molars with deep carious lesions - Absence of clinical signs and symptoms of irreversible pulpitis, fistula, swelling in periodontal tissues or abnormal tooth mobility - Absence of adverse radiographic findings - Compliant patient/parent and (e) Absence of any systemic disease. Exclusion Criteria: • Previously restored teeth . |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative pain: verbal rating scale | categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome | 2 months | |
Primary | postoperative pain: verbal rating scale | categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome | 6 months | |
Primary | postoperative pain: verbal rating scale | categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome | 9 months | |
Primary | postoperative pain: verbal rating scale | categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome. | 12 months | |
Secondary | Presence or absence of pain on percussion | Binary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror | 2,6,9 and 12 months | |
Secondary | Swelling | Binary outcome (Present or absent). Assessed by visual examination by the examiner | 2,6,9 and 12 months | |
Secondary | Sinus or fistula | Binary outcome (Present or absent). Assessed by visual examination by the examiner | 2,6,9 and 12 months | |
Secondary | Adverse radiographic findings | Binary outcome (Present or absent). Assessed by Digora software | 2,6,9 and 12 months | |
Secondary | Thickness of newly formed dentin | using the Digora software. Unit of measurements were mm | 2,6,9 and 12 months |
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