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

NCT05819970 | Completed Phase 1

• 1 other identifier: University-UHS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Vital Teeth

Outcome Measures

Primary Outcomes (1)

• Antibacterial effect

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

  1 week

Study Arms (2)

Allium sativum oil (Experimental-Group A)

EXPERIMENTAL

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

Turmeric gel (Experimental-Group B)

EXPERIMENTAL

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 DRUG

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

Also known as: Medicaments for non-vital pulpotomy procedure

Allium sativum oil (Experimental-Group A)

Turmeric Gel DRUG

Turmeric gel will be used as non-vital pulpotomy medicament

Also known as: Medicaments for non-vital pulpotomy procedure

Turmeric gel (Experimental-Group B)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Health Sciences Lahore: lead
• Lahore General Hospital: collaborator

Study Sites (1)

de' Montmorency College of Dentistry

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

allyl sulfide

Study Officials

• Shazia Naz, BDS, MDS

  Associate Professor of Operative Dentistry (Supervisor)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dental Surgeon (Ex-Postgraduate trainee)

Model Details: patients and assessors involved in the study from randomization, allocation, bacteriological outcome, and data analysis will be blinded to which medicament group the patients belonged as all data will be coded.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: October 20, 2022
• Primary Completion: February 23, 2023
• Study Completion: March 2, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

PA (1)