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

An evaluation of nano-hydroxyapatite as a pulpotomy medicament in primary teeth.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014785
Enrollment
69
Registered
2018-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Healthy patients with deep carious primary molars.

Interventions

Intervention1: Nano hydroxyapaptite Calicum hydroxide with 3% Nano-hydroxyapatite Mineral Trioxide Aggregate : Calcium hydroxide, Azure laborateries Hydroxylapatite nanoparticles,Nanobeach white na

Sponsors

Dr Monika Grewal
Lead Sponsor

Eligibility

Inclusion criteria

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: 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)

Design outcomes

Primary

MeasureTime frame
No clinical sign of pulp degeneration No radiographic sign of root and bone resorptionTimepoint: Timepoints of measuring primary outcome is 3 months, 6 months, 9 months.

Secondary

MeasureTime frame
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.

Countries

India

Contacts

Public ContactDr Monika Grewal

Faculty of Dental Sciences,KGMU

rajkids2000@yahoo.co.in9450849528

Outcome results

None listed

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