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Azadirachta Indica (Neem) Extract as an Adjunct to Non-Surgical Periodontal Management

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Azadirachta Indica
Non Surgical Periodontal Therapy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Azadirachta Indica, Locally Delivery, TNF-α

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Both males and females will be included in the age group of 20-55 years old. Patients diagnosed to have (Stage II or Stage III) periodontitis; (3-6 mm CAL, pocket depth ≤ 7 mm, mostly horizontal 15%-33% bone loss as assessed by preoperative radiographs with no tooth loss due to periodontitis). Patients free from systemic diseases according to the modified Burkett's health history questionnaire. Patients who can follow and maintain oral hygiene instructions. Patients who didn't perform any periodontal therapy in the last 6 months. Exclusion Criteria: Pregnant ladies or lactating mothers. Smokers. Patients with history of allergy against one of the components of neem. Asthmatic patients

Sites / Locations

  • Faculty of Dentistry -Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Azadirachta Indica

Non Surgical Periodontal Therapy

Arm Description

Azadirachta Indica (neem) gel are locally delivered to deepest part of the periodontal pocket by syringe with blunted tip gently and removed slowly in order not to harm the tissue for group 1 patients after phase 1 therapy by two weeks.

The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education.

Outcomes

Primary Outcome Measures

clinical score
Measuring plaque index, Modified sulcus bleeding index, Probing depth, 4. Clinical attachment level.

Secondary Outcome Measures

Tumor Necrosis Factor alpha
Measuring concentrations of Tumor Necrosis Factor (TNF-α).

Full Information

First Posted
September 17, 2023
Last Updated
September 17, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT06050174
Brief Title
Azadirachta Indica (Neem) Extract as an Adjunct to Non-Surgical Periodontal Management
Official Title
Efficacy of Locally Delivered Azadirachta Indica (Neem) Extract as an Adjunct to Non-Surgical Periodontal Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Azadirachta-Indica has various therapeutic activities such as antiseptic, antiulcer, astringent, superior antiviral and for cleaning the teeth in various dental diseases in vitro and vivo. It also purifies blood, removes toxins from the body and neutralizes free radicals. Due to its therapeutic effects, ease of availability of neem, being cost effective and its safety with no adverse reactions, Azadirachta-Indica has been selected for this study as a local drug delivery in the gel form to be placed in periodontal pockets as an adjunct to non-surgical periodontal debridement for the management of localized periodontitis.
Detailed Description
Total number of thirty-two (32) periodontitis patients including both males and females will be included in the study. To assess the effect of neem gel on the clinical parameters of patients with localized periodontitis t-test or an equivalent non-parametric test will be used for comparison of Intervention group (neem extract gel) and Control group (non-surgical periodontal debridement). At first preoperative periapical radiographs will be taken for assessment of bone level. The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education. Baseline assessment will be done following phase I therapy by 2 weeks by full mouth periodontal charting and samples from gingival crevicular fluid will be taken using a sterile perio-paper inserted into the deepest periodontal pocket with horizontal bone loss. AzadirachtaIndica Extract Gel will be applied in the deepest pocket by syringe with blunted tip gently and removed slowly in order not to harm the tissue for group 1 patients after phase 1 therapy by two weeks. Follow up of the patients will be done after 3 months after phase I therapy with evaluation of the clinical parameters. The patients will be instructed to brush their teeth 3 times per day during the treatment period using a soft tooth brush together with regular flossing of teeth. A brochure containing written oral hygiene instructions will be given to the patients. The clinical parameters will be measured two times during the study, the first time at the baseline after two weeks of full mouth debridement and the second time is after baseline by 3 months. GCF sampling will be done just before neem gel application. Mean values of each parameter will be calculated per patient and per group as well as parameters at the deepest pocket site. A full mouth periodontal charting will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, Azadirachta Indica, Locally Delivery, TNF-α

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azadirachta Indica
Arm Type
Experimental
Arm Description
Azadirachta Indica (neem) gel are locally delivered to deepest part of the periodontal pocket by syringe with blunted tip gently and removed slowly in order not to harm the tissue for group 1 patients after phase 1 therapy by two weeks.
Arm Title
Non Surgical Periodontal Therapy
Arm Type
Placebo Comparator
Arm Description
The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education.
Intervention Type
Drug
Intervention Name(s)
Azadirachta Indica
Other Intervention Name(s)
Neem, Nimba, Vembu, Arishtha
Intervention Description
Azadirachtaindica L. is a multipurpose medicinal tree of family Meliaceae.Is also named "Nimba", "holy tree", "Vembu", "Arishtha", "Indian neem tree", "Indian lilac", "wonder tree. It occurs in tropical and semitropical regions of the world. Almost all parts of this incredible tree have been used as phytomedicines for more than 4,000 years. Various pharmacological attributes such as antifungal, antiviral, antibacterial, anti-inflammatory, sterilant, antiscabic, antiallergenic and analgesic are attributed to various parts of the tree.
Intervention Type
Procedure
Intervention Name(s)
Non Surgical Periodontal Therapy
Other Intervention Name(s)
Periodontal Debridement
Intervention Description
The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education.
Primary Outcome Measure Information:
Title
clinical score
Description
Measuring plaque index, Modified sulcus bleeding index, Probing depth, 4. Clinical attachment level.
Time Frame
change from baseline at 3 months
Secondary Outcome Measure Information:
Title
Tumor Necrosis Factor alpha
Description
Measuring concentrations of Tumor Necrosis Factor (TNF-α).
Time Frame
change from baseline at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both males and females will be included in the age group of 20-55 years old. Patients diagnosed to have (Stage II or Stage III) periodontitis; (3-6 mm CAL, pocket depth ≤ 7 mm, mostly horizontal 15%-33% bone loss as assessed by preoperative radiographs with no tooth loss due to periodontitis). Patients free from systemic diseases according to the modified Burkett's health history questionnaire. Patients who can follow and maintain oral hygiene instructions. Patients who didn't perform any periodontal therapy in the last 6 months. Exclusion Criteria: Pregnant ladies or lactating mothers. Smokers. Patients with history of allergy against one of the components of neem. Asthmatic patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala A. Abuel-Ela, Professor
Organizational Affiliation
Faculty of dentistry- Ain shams University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry -Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Azadirachta Indica (Neem) Extract as an Adjunct to Non-Surgical Periodontal Management

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