MedPath

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

Phase 3
Active, not recruiting
Conditions
Healthy patients with deep carious primary molars.
Registration Number
CTRI/2018/07/014785
Lead Sponsor
Dr Monika Grewal
Brief Summary

Despite modern advances in the prevention ofdental caries and increased understanding of the importance of maintaining thenatural primary dentition, many teeth are still lost prematurely. Pulpotomy has remained an acceptable and mainstay treatment inpreserving the vitality of the primary tooth and prolonging its life till thepermanent successor erupts. The present study is a randomized, double blind, parallel group, active controlled trial to evaluate  and compare theefficacy, both clinically and radiographically, of our new medicament Nano-hydroxyapatite and calcium hydroxide with 3% Nano-hydroxyapatite with the standard material MTA for pulpotomy.

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
All
Target Recruitment
69
Inclusion Criteria
  • symptom-free deep carious mandibular primary molar tooth with vital pulp, sufï¬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, ï¬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
No clinical sign of pulp degenerationTimepoints of measuring primary outcome is 3 months, 6 months, 9 months.
No radiographic sign of root and bone resorptionTimepoints 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)Timepoints of measuring secondary outcome is 3 months,6 months, 9 months.

Trial Locations

Locations (1)

King George’s Medical University, Lucknow

🇮🇳

Lucknow, UTTAR PRADESH, India

King George’s Medical University, Lucknow
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Monika Grewal
Principal investigator
7054473661
monikagrewal16@gmail.com

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