Clinical trial NCT06050174: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Keywords: Periodontitis
Azadirachta Indica
Locally Delivery
TNF-α
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Both males and females will be included in the age group of 20-55 years old.
2. 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).
3. Patients free from systemic diseases according to the modified Burkett's health history questionnaire.
4. Patients who can follow and maintain oral hygiene instructions.
5. Patients who didn't perform any periodontal therapy in the last 6 months.

Exclusion Criteria:

1. Pregnant ladies or lactating mothers.
2. Smokers.
3. Patients with history of allergy against one of the components of neem.
4. Asthmatic patients

Primary outcomes:
measure: clinical score
timeFrame: change from baseline at 3 months
Secondary outcomes:
measure: Tumor Necrosis Factor alpha
timeFrame: change from baseline at 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry -Ain Shams University
Study officials:
affiliation: Faculty of dentistry- Ain shams University
name: Hala A. Abuel-Ela, Professor
role: STUDY_DIRECTOR
References: