Allium Sativum Extract as an Irrigant

Infected Root Canals of Primary Molars Clinical Trial

Official title:

Allium Sativum Extract as an Irrigant in Pulpectomy of Primary Molars: 12 Month In-vivo Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795636
• Other study ID #: 307
• Status: Completed
• Phase: N/A
• Start date: October 30, 2016
• Est. completion date: August 15, 2018

Study information

• Verified date: October 2019
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Garlic extract as herbal compound has potent antibacterial properties and can be used safely as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and radiographic outcomes

Description:

Aim: This study indented to assess the clinical and radiographic assessment of garlic extract as an intracanal irrigant for pulpectomy of primary molars.

Methodology: 91 child with 100 teeth submitted into this study were equally categorized into the test group (group 1) which irrigated with garlic extract and control group (group 2) that received sodium hypochlorite (NaOCl). Then, each group has been subjected to further specification according to the tooth preoperative clinical and radiographic features into has been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12 months. Fisher's exact test for binary variable was used for data analysis with p-value ≤ 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 15, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

1. Class I or II according to American Society of Anesthesiologists (ASA)

2. Irreversible pulpititis recognised through; (1) profuse bleeding from root canal orifices after complete debridement of coronal pulp tissue and cannot be dominated by moist cotton pellet. (2) History of lingered thermal pain spontaneous nocturnal pain

3. Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain

4. Pathological tooth mobility

5. Percussion sensitivity

6. Swelling close to involved tooth accompanied with or without fistula Radiographic characteristics of the root and supporting structures

1. Normal radiographic findings

2. Interruption of lamina dura

3. Furcation radiolucency

Exclusion Criteria:

• Specifications of exclusion

1. Uncooperativeness of child and/or parents or caregivers behavior

2. Unrestorable tooth

3. Presence of internal root resorption

4. Presence of calcific metamorphosis inside root canals

5. Presence of root resorption exceeding one third of its length

Related Conditions & MeSH terms

• Infected Root Canals of Primary Molars

Intervention

Other:
• Garlic extract
A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water
• NaOCl (COLTENE®)
Sodium hypochlorite

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral examination	Pain assessment using Visual Analog Score for pain	12 months
Primary	radiographic success or failure	Radiographic assessment using periapical radiograph and score (0) applied for absence of radiolucency and score (1) for presence of radiolucency	12 months
Secondary	Types of failures	detecting the percent of different failure types accompanied with pulpectomy procedures after using garlic as an irrigant solution.	12 months