Silver Diamine Fluoride After Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries

Deep Caries Clinical Trial

Official title:

Postoperative Pain After Application of Silver Diamine Fluoride and Glass Ionomer Versus Glass Ionomer Alone Following Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries. A Randomized Pilot Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03568474
• Other study ID #: Egypt Cairo University
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Deep Caries

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