Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament 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 this randomized controlled clinical trial is to use Allium sativum oil 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 Allium sativum oil compared with Formocresol, 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 (Formocresol) and Group B (Allium sativum oil). 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 Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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 Groups

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Formocresol (Control-Gold standard-Group A)

Premade Formocresol (Tricresol \& Formalin) will be used in this research. Composition was Tricresol 35%, Formaldehyde (40%) 19%, excipient additive 100% (PD, Switzerland, ISO9001/ISO9001\_2000/ ISO13485/CE\_MARK), (Universal Dental Pvt, Ltd)

Group Type ACTIVE_COMPARATOR

Formocresol

Intervention Type DRUG

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

Allium sativum oil (Experimental-Group B)

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 compared with Formocresol (which is gold standard)

Interventions

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Formocresol

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

Intervention Type DRUG

Allium Sativum Oil

Allium sativum oil will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard)

Intervention Type DRUG

Other Intervention Names

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medicament for Non-vital pulpotomy procedure medicament 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 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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes