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

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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03568474

Enrollment

Registered

2018-06-26

Start date

2018-10-31

Completion date

2020-04-30

Last updated

2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Caries

Brief summary

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

Detailed 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.

Interventions

DRUGSilver Diamine Fluoride

Indirect pulp capping material

DRUGGlass Ionomer

Indirect pulp capping material

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

The participant, care provider, outcomes assessor and statistician will be masked

Intervention model description

parallel two arm groups with 1:1 allocation ratio

Eligibility

Sex/Gender

ALL

Age

6 Years to 9 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Postoperative Pain	9 months	Will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)

Secondary

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

Contacts

Primary ContactRehan Anwar, MSc

rehananwar28@hotmail.com+201210339553

Backup ContactSara A Mahmoud, PhD

sara_yn79@yahoo.com+201000042564

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026