Azadirachta Indica (Neem) Extract as an Adjunct to Non-Surgical Periodontal Management
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Azadirachta Indica; Non Surgical Periodontal Therapy
Intervention type(s): Drug; Procedure
Intervention description(s): 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.; The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education.
Other intervention name(s): Neem; Nimba; Vembu; Arishtha; Periodontal Debridement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Periodontitis; Azadirachta Indica; Locally Delivery; TNF-α