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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-20

Study Completion Date

2023-03-02

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Non Vital Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Allium Sativum Oil

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Turmeric Gel

Intervention Type DRUG

Turmeric gel will be used as non-vital pulpotomy medicament

Interventions

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Allium Sativum Oil

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

Intervention Type DRUG

Turmeric Gel

Turmeric gel will be used as non-vital pulpotomy medicament

Intervention Type DRUG

Other Intervention Names

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Medicaments for non-vital pulpotomy procedure Medicaments for non-vital pulpotomy procedure

Eligibility Criteria

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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

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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes