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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05801354
Other study ID # UHSUniversity
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 20, 2022
Est. completion date March 2, 2023

Study information

Verified date March 2023
Source University of Health Sciences Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this randomized controlled clinical trial is to use Turmeric gel as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that there is no difference in the antibacterial effect of Turmeric gel compared with Formocresol, when used as non-vital Pulpotomy medicaments.


Description:

It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Formocresol) and Group B (Turmeric gel). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2, 2023
Est. primary completion date February 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 8 Years
Eligibility Inclusion Criteria: 1. Cooperation of patients and consent of parents. 2. Patients with ASA classification I and II (mild to moderate systemic disease). 3. Non-traumatic extensively carious hence restorable primary molars. 4. No history of antibiotic use for 2 weeks. 5. Presence of following clinical signs or symptoms suggestive of non-vital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/ redness/ swelling, and/or slight mobility-grade I. Exclusion Criteria: 1. History of allergy to anesthetics and latex. 2. Radiographic evidence of pulpal floor opening into the furcation area. 3. More than half of the roots resorbed.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Turmeric Gel
Turmeric gel will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard)
Formocresol
Formocresol will be used as non-vital pulpotomy medicament (which is gold standard)

Locations

Country Name City State
Pakistan de' Montmorency College of Dentistry Lahore Punjab

Sponsors (2)

Lead Sponsor Collaborator
University of Health Sciences Lahore Lahore General Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibacterial effect Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml) 1 week
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03998826 - Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars N/A
Completed NCT05801367 - Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth Phase 1/Phase 2