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

Phase 3

• Conditions: arge caries of primary teeth.; Partial loss of teeth due to caries; K08.43

• Registration Number: IRCT20230530058338N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 66

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ormal 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.