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Pulp effect with silver diamine fluoride and calcium hydroxide in primary teeth

Comparative study of clinical and radiographic outcomes of indirect pulp treatment with silver diamine fluoride versus calcium hydroxide in primary teeth: a randomized controlled clinical trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230530058338N1
Enrollment
66
Registered
2023-06-11
Start date
2023-07-06
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Large caries of primary teeth. Partial loss of teeth due to caries

Interventions

Intervention 1: Intervention group: A deep injection of local anesthesia is performed using lidocaine and the tooth is isolated with a cotton roll. The caries removal of the outer walls of the cavity

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: Children without systemic disease who are cooperative according to Frankel classification, Frankel 3 and 4. On clinical examination, large carious lesions involving the occlusal or proximal surfaces, with normal gingival appearance and having at least one decayed deciduous molar on each side of the mandible or maxilla. In the radiographic examination, the observation of caries close to the pulp that involved about two-thirds of the thickness of the dentin, normal lamina dura, normal periodontal ligament space, root length more than two-thirds, absence of periapical changes, absence of external or internal pathological analysis.

Exclusion criteria

Exclusion criteria: A history of sharp, piercing pulpal pain that persists after removal of the stimulus, as well as spontaneous pain and nocturnal pain Clinical examination showing tooth mobility, tooth discoloration, sinus tract or tooth abscess Radiographic examination showing a carious lesion with intermittent exposure of the pulp, interrupted lamina dura, widening of the periodontal ligament space, periapical radiolucency and internal or external pathological degeneration. Children with absolute sensitivity to any kind of anesthetic

Design outcomes

Primary

MeasureTime frame
Normal gums. Timepoint: After 3 and 6 months. Method of measurement: Clinical assessment.;Absence of abscess and fistula. Timepoint: After 3 and 6 months. Method of measurement: Clinical assessment.;Absence of desired toothache. Timepoint: After 3 and 6 months. Method of measurement: Clinical assessment.;No internal and external degeneration. Timepoint: After 6 months. Method of measurement: Radiographic evaluation.;Lack of widening of the periodontal ligament space. Timepoint: After 6 months. Method of measurement: Radiographic evaluation.;No furca involvement. Timepoint: After 6 months. Method of measurement: Radiographic evaluation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahram Mosharrafian

Tehran University of Medical Sciences

shahramosharrafian@yahoo.com+98 21 8889 6696

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026