MedPath

A clinical study to evaluate the effect of new medicament to save the primary teeth.

Phase 3
Conditions
Health Condition 1: null- Healthy patients with deep carious primary molars.
Registration Number
CTRI/2018/07/014785
Lead Sponsor
Dr Monika Grewal
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

symptom-free deep carious mandibular primary molar tooth with vital pulp,

suf�cient tooth structure for restoration with a stainless steel crown,

no history of spontaneous pain,

no clinical evidence of extensive pulp degeneration or periapical pathology,including tenderness to percussion, tooth mobility, abscess, �stula, or swelling of the gingiva,

no radiographic evidence of periapical pathosis or inter-radicular bone loss,internal resorption, pulp calcification, ankylosis, or pathologic external root resorption.

Physiologic root resorption, while included in the criteria, could not be more than one-third of the root length.

Exclusion Criteria

Exclusion criteria included the presence of any systemic pathology

any history of allergic reaction to latex, local anesthetics or to the constituents of the tested pulp dressing agents.

Clinical or radiographic sign or symptoms of pulp degeneration(i.e. spontaneous pain, excessive bleeding from the root canal,inter-radicular and/or periapical bone destruction)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
o clinical sign of pulp degeneration <br/ ><br>No radiographic sign of root and bone resorptionTimepoint: Timepoints of measuring primary outcome is 3 months, 6 months, 9 months.
Secondary Outcome Measures
NameTimeMethod
The restoration performance (partially or completely lost fillings, secondary caries at the margin, perforated or lost Stainless Steel crowns, severe Gingival inflammation)Timepoint: Timepoints of measuring secondary outcome is 3 months,6 months, 9 months.
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