Effects of Allium Sativum and Moringa Oleifera Extract on Dental Enamel

NCT05744752 | Unknown DMC

• 1 other identifier: Trial2022001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective is to observe the effects of lead on dental enamel of rabbit by measuring;

• Structural and morphological change by SEM, AFM
• Elemental composition by SEM-EDX
• Molecular composition and hydroxyapatite crystal changes by Raman Spectroscopy
• Blood parameters by serum analysis Secondary objectives includes
• To compare the protective effects of Allium sativum and Moringa oleifera on dental enamel defects due to lead
• To determine the beneficial effects of AS and MO extract in remineralization of dental enamel.

Conditions

Lead Poisoning

Keywords

Moringa oleifera extract; Allium sativum extract; Dental Enamel; Rabbits

Outcome Measures

Primary Outcomes (1)

• Histological Outcomes

  In this examination Odontoblastic zone, Cell nuclei Vacuolization of odontoblasts, Acute Inflammation, Chronic Inflammation, Apatite formation, Collagen crosslinking will be determined inform of normal or abnormal.

  at the end of the study

Secondary Outcomes (1)

• Mineral Concentration

  at the end of the study

Study Arms (6)

Group A

OTHER

Control; Placebo 1ml NaCl 0.9% daily for 12 weeks

Other: Placebo

Group B

ACTIVE COMPARATOR

Pb Group; Lead acetate 19.5mg/kg b.w daily for 12 weeks

Other: Lead Acetate

Group C

EXPERIMENTAL

Pb + Allium sativum extract; Lead acetate 19.5mg/kg b.w followed by Allium sativum(AS) extract 500 mg/kg b.w daily for 12 weeks

Other: Lead Acetate; Dietary Supplement: Allium sativum Extract

Group D

OTHER

CPb + Moringa oleifera extract; Lead acetate 19.5mg/kg b.w followed by Moringa oleifera extract 400mg/kg b.w daily for 12 weeks

Other: Lead Acetate; Dietary Supplement: Moringa oleifera Extract

Group E

ACTIVE COMPARATOR

Allium sativum extract; Allium sativum extract 500mg/kg b.w daily for 12 weeks

Dietary Supplement: Allium sativum Extract

Group F

EXPERIMENTAL

Moringa oleifera extract; Moringa oleifera extract 400mg/kg b.w daily for 12 weeks

Dietary Supplement: Moringa oleifera Extract

Interventions

Lead Acetate OTHER

The oral LD50 of lead acetate is 390mg/kg body weight. The experimental group B, C, and D will receive a single dose of 19.5 mg/kg b.w (1/120th of LD50),31 daily dissolved in distilled water and given by oral gavage method for 12 weeks. Lead acetate Pb(CH3COO)2x3H2O, will be purchased from Sigma-Aldrich Chemie (Germany).

Group B; Group C; Group D

Moringa oleifera Extract DIETARY_SUPPLEMENT

The method described by Hanaa Elgamily(32) with minor modifications. Fresh Leaves will be washed and dried in dry heat oven. All the preparation will be done in pharmacological department, University of Health Sciences in sterile environment. Dried leaves will be crushed to make fine powder. 1000 g powder of MO will be socked in 5000 ml of 70% ethanol (70% ethanol and 30% distilled water) for 72 hours at room temperature. Then mixture will be magnetically stirred for 24 hours and stored at 4oC for 48 hours to allow extraction of active ingredients. Then the mixture will be filtered twicely by using Whatman No 1 filter paper. The extract will be concentrated by rotary vacuum evaporator at 40 oC to evaporate the solvent. The extract will be freeze, dried and stored at -70 oC for use. Dose of MO extract will be 400 mg per kg.(33) body weight given daily in 1ml of distilled water by oral gavage method for 12 weeks.

Group D; Group F

Allium sativum Extract DIETARY_SUPPLEMENT

Fresh Allium sativum bulbs will be selected for study. The cloves will be peeled, washed with distilled water and dried under shed. Then it will be chopped into small pieces. 1000g of chopped garlic will be crushed by mortar and passel. The garlic paste will be mixed with 5000 ml of 70% ethanol (70% ethanol and 30% distilled water) for 72 hours at room temperature. Rest the procedure is same as mentioned in moringa extract. Dose of 500 mg per kg(34) body weight garlic extract will be given daily in 1ml of distilled water.

Group C; Group E

Placebo OTHER

1ml NaCl 0.9% daily for 12 weeks

Group A

Eligibility Criteria

• Age: 3 Months - 5 Years
• Gender Eligibility Details: Healthy male rabbits of average weight 1-2 kg
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy rabbits
• Rabbits Age 9-10 weeks
• Weight 1000-1200 g will be selected

You may not qualify if:

• Diseased rabbit
• Age: More than 10 weeks and less than 9 weeks
• Weight more than 1200 g and less than 1000 g

Sponsors & Collaborators

• Arslan Saleem: lead
• Baqai Medical University: collaborator

Study Sites (1)

Baqai Medical University

Karachi, Sindh, 75340, Pakistan

Location

Related Publications (3)

• Du Toit N, Kempson SA, Dixon PM. Donkey dental anatomy. Part 2: Histological and scanning electron microscopic examinations. Vet J. 2008 Jun;176(3):345-53. doi: 10.1016/j.tvjl.2008.03.004. Epub 2008 Apr 18.

  PMID: 18396075 BACKGROUND

• Six N, Lasfargues JJ, Goldberg M. Differential repair responses in the coronal and radicular areas of the exposed rat molar pulp induced by recombinant human bone morphogenetic protein 7 (osteogenic protein 1). Arch Oral Biol. 2002 Mar;47(3):177-87. doi: 10.1016/s0003-9969(01)00100-5.

  PMID: 11839353 BACKGROUND

• Yu C, Abbott PV. An overview of the dental pulp: its functions and responses to injury. Aust Dent J. 2007 Mar;52(1 Suppl):S4-16. doi: 10.1111/j.1834-7819.2007.tb00525.x.

  PMID: 17546858 RESULT

MeSH Terms

Conditions

Lead Poisoning

Interventions

lead acetate

Condition Hierarchy (Ancestors)

Heavy Metal Poisoning; Poisoning; Chemically-Induced Disorders

Study Officials

• Rashid Javaid, Ph.D scholar

  Baqai Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: It is an animal model study and the investigator will mask the groups as "A, B, C, D, E, F" so the outcome assessor will be blinded.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Statistical Officer

Model Details: A total of 90 male rabbits of average weight 1-2 kg will be obtained from the animal house of COMSATS University, Lahore. These rabbits will be segregated into 06 groups, each group consisting of 15 rabbits. All rabbits will be kept safe in iron cages under controlled temperature (25±2 C), humidity (55 ± 5%), and 12-hour dark-light cycle. One week after their acclimatization into a new environment the trial will begin. All experimental protocols will be performed following the guidelines for the human use of laboratory animals established at COMSATS University, Lahore.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: February 27, 2023
• Study Start: December 19, 2022
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)