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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03568474
Other study ID # Egypt Cairo University
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date October 2018
Est. completion date April 2020

Study information

Verified date June 2018
Source Cairo University
Contact Rehan Anwar, MSc
Phone +201210339553
Email rehananwar28@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is comparing between the Silver Diamine Fluoride after minimal caries removal versus glass ionomer in permanent teeth with open apex


Description:

The study will be carried on young permanent molars with open apices & with deep caries. Incomplete caries removal and application of indirect pulp capping materials where Silver Diamine Fluoride (Group I) will be compared with glass ionomer only (group II). Then final restoration with composite resin for both groups. Children will be followed up for 9 months.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date April 2020
Est. primary completion date October 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 9 Years
Eligibility Inclusion criteria:

1. Patients free from any systematic diseases.

2. Young permanent molars with incompletely formed roots having deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed.

3. Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility)

4. The absence of clinical symptoms of irreversible pulpitis.

5. Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal space, internal and external root resorption).

6. Compliant patient/ parent.

Exclusion criteria:

1. Teeth with previous restorative treatment.

2. Unrestorable teeth.

3. Uncooperative patients.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Silver Diamine Fluoride
Indirect pulp capping material
Glass Ionomer
Indirect pulp capping material

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain Will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no) 9 months
Secondary Tooth vitality Will be assessed by Vitality test using thermal stimulation, binary (yes or no) 9 months
Secondary Abscess Will be assessed intraoral Clinical examination whether there is swelling or not, binary (yes or no) 9 months
Secondary Pain on percussion Will be assessed by Percussion test by using the back of the mirror on the tooth, binary (yes or no) 9 months
Secondary Root lengthening Will be assessed measuring the root length by mm on the digital radiography (digora software) 9 months
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