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CompletedNCT05819970Updated Apr 19, 2023

Allium Sativum Oil and Turmeric Gel as Alternative Non-vital Pulpotomy Medicaments in Primary Teeth.

A Phase 1/2 interventional study of Allium Sativum Oil and Turmeric Gel in Non Vital Teeth, sponsored by University of Health Sciences Lahore. Completed at 1 site in Pakistan. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by University of Health Sciences Lahore · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2022, registered Apr 2023).
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
01

Study summary

The purpose of the study is to use Allium sativum oil and Turmeric gel as non-vital Pulpotomy medicaments in primary teeth by evaluating their antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus.

It is hypothesized that there is no difference in the antibacterial effect of Allium sativum oil and Turmeric gel when used as non-vital Pulpotomy medicaments.

Read the detailed 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 (Allium sativum oil) 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).

02

Conditions studied

  • Non Vital Teeth
03

In context

Lead sponsor

University of Health Sciences Lahore is the lead sponsor of 80 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 nonvital 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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Allium sativum oil (Experimental-Group A)

    Premade Allium sativum oil (Garlic oil) (Mohammad and Baroudi, 2015b) will be used in this research (SAC group of companies-9001:2015 certified; Registration # PAK17.1724-U; NTN # 0299739-8, Karachi, Pakistan

    Drug: Allium Sativum Oil

  • Experimental
    Turmeric gel (Experimental-Group B)

    Turmeric gel will be self-prepared at the Institute of Microbiology and Molecular Genetics, Punjab University, Lahore. 2kgs of Turmeric rhizomes were purchased from a local market in Lahore and verified by a taxonomist, Botany Department, Government College University, Lahore (voucher number: GC.Herb.Bot.3693). Approximately 170g powder along with 550ml distilled water will be taken in a Soxhlet extractor for 96 hours and then filtered repeatedly through Whatman No.1 filter paper. The obtained filtrate will then be mixed with 6% Sodium Carboxy-Methyl Cellulose (NaCMC) (Genevex Chem, Hyderabad, India) to form gel. Four Vitamin C grounded tablets (Wilson's Vitamin C, Wilson's Healthcare, Islamabad, Pakistan) and twelve Vitamin E capsules (Evion, Martin Dow pharmaceuticals, Ltd. Karachi, Pak) will then be added in 100g of gel as antioxidants.

    Drug: Turmeric Gel

Interventions

  • Allium sativum oil will be used as non-vital pulpotomy medicament

    Also known as: Medicaments for non-vital pulpotomy procedure

  • DrugTurmeric Gel

    Drug pages: Turmeric extract · Curcuma longa

    Turmeric gel will be used as non-vital pulpotomy medicament

    Also known as: Medicaments for non-vital pulpotomy procedure

06

What researchers measure

Primary outcomes

  1. Antibacterial effect

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

    Time frame: 1 week

07

Study locations

1 site
  • de' Montmorency College of Dentistry
    Lahore, Punjab Province 54000, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05819970
Lead sponsor
University of Health Sciences Lahore
Collaborators
Lahore General Hospital
Responsible party
Dr. Mashal Mazhar (Dental Surgeon (Ex-Postgraduate trainee), University of Health Sciences Lahore) — Principal investigator
First posted
Apr 19, 2023
Start date
Oct 20, 2022
Primary completion
Feb 23, 2023
Completion
Mar 2, 2023
Last update
Apr 19, 2023

Study contacts

Shazia Naz, BDS, MDS
study director · Associate Professor of Operative Dentistry (Supervisor)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Allyl sulfide · Turmeric extract · Curcuma longa

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