NCT06050174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

September 17, 2023

Last Update Submit

September 17, 2023

Conditions

Periodontitis

Keywords

PeriodontitisAzadirachta IndicaLocally DeliveryTNF-α

Outcome Measures

Primary Outcomes (1)

  • clinical score

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

    change from baseline at 3 months

Secondary Outcomes (1)

  • Tumor Necrosis Factor alpha

    change from baseline at 3 months

Study Arms (2)

Azadirachta Indica

EXPERIMENTAL

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.

Drug: Azadirachta IndicaProcedure: Non Surgical Periodontal Therapy

Non Surgical Periodontal Therapy

PLACEBO COMPARATOR

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

Procedure: Non Surgical Periodontal Therapy

Interventions

Azadirachta IndicaDRUG

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.

Also known as: Neem, Nimba, Vembu, Arishtha
Azadirachta Indica
Non Surgical Periodontal TherapyPROCEDURE

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

Also known as: Periodontal Debridement
Azadirachta IndicaNon Surgical Periodontal Therapy

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant ladies or lactating mothers.
  • Smokers.
  • Patients with history of allergy against one of the components of neem.
  • Asthmatic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry -Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

neem oilPeriodontal Debridement

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental ProphylaxisPeriodonticsDentistry

Study Officials

  • Hala A. Abuel-Ela, Professor

    Faculty of dentistry- Ain shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2023

First Posted

September 22, 2023

Study Start

September 1, 2021

Primary Completion

April 15, 2023

Study Completion

July 1, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

EG(1)