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
Name Time Method No clinical sign of pulp degeneration Timepoints of measuring primary outcome is 3 months, 6 months, 9 months. No radiographic sign of root and bone resorption Timepoints of measuring primary outcome is 3 months, 6 months, 9 months.
- Secondary Outcome Measures
Name Time Method 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, IndiaDr Monika GrewalPrincipal investigator7054473661monikagrewal16@gmail.com