Skip to main content
OpenTrials
Completed

NCT Number: NCT05801354

Turmeric Gel as Alternative Non-vital Pulpotomy Medicament in Primary Teeth

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

de' Montmorency College of Dentistry

Lahore, Punjab Province, 54000, Pakistan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cooperation of patients and consent of parents.
  • Patients with ASA classification I and II (mild to moderate systemic disease).
  • Non-traumatic extensively carious hence restorable primary molars.
  • No history of antibiotic use for 2 weeks.
  • 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

  • History of allergy to anesthetics and latex.
  • Radiographic evidence of pulpal floor opening into the furcation area.
  • More than half of the roots resorbed.

Treatment and study plan

Turmeric Gel

Drug

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

Other names: Medicaments for non-vital pulpotomy procedure

Formocresol

Drug

Formocresol will be used as non-vital pulpotomy medicament (which is gold standard)

Other names: Medicaments for non-vital pulpotomy procedure

Primary outcomes

  1. Antibacterial effect

    Time frame: 1 week

    Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml)

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Collaborators

  • Lahore General Hospital

Registry information

Official study title

Turmeric Gel as Alternative Non-Vital Pulpotomy Medicament in Primary Teeth-A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.