The Clinical Assessment of Nigella Sativa Oil vs Chlorohexidine as a Therapeutic Aid for Gingivitis, Effect on Gingival IL-6 and IL-18 and Antimicrobial Efficacy.
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      A double-blind randomized clinical trial was conducted for 14 days with 37 systemically
      healthy patients having chronic generalized gingivitis. The current study was designed to
      investigate the anti-inflammatory and antimicrobial efficacy of Nigella Sativa oil compared
      with chlorohexidine; assessing clinical parameters and gingival interleukin 6 (IL6) and
      interleukin 18 (IL18) levels and supra-gingival plaque analysis.
    

Detailed description: 
      A total of 37 systemically healthy patients, aged between 20 to 40 years with chronic
      generalised gingivitis were recruited based on the inclusion and exclusion criteria, from the
      Dental Clinic at Princess Nourah bint Abdulrahman University. The sample size was based on
      previously reported studies conducted to assess gingival crevicular interleukin levels using
      mouthwashes. A study information sheet was provided to each patient and the methodology of
      the clinical trial was explained. Written informed consent was obtained from each participant
      before enrolling on the study.

      A double-blind randomized clinical trial was conducted Ethical clearance was obtained from
      the Institutional Review Board at Princess Nourah bint Abdulrahman University (Registration
      number: 20-0261).

      Subjects were assigned computer-generated random numbers and were blindly assigned to one of
      two groups; Group 1- Nigella Sativa (NS) or Group 2- Chlorohexidine (CHX) (n=20) according to
      the sequence of the computer-generated random numbers by an investigator not directly
      involved in the clinical examination and sample collection. The interventions were either N.
      sativa oil (Al-Hussan Food Products Factory, Riyadh, Kingdom of Saudi Arabia), which was
      brought from the local market in Riyadh or Chlorohexidine (Middle East Pharmaceutical
      Industries Ltd, Riyadh, Kingdom of Saudi Arabia). Group 1: Maintained adequate plaque control
      levels using mechanical methods + N.sativa oil (5ml oil + 5ml water) pulling for 3 mins twice
      daily in the morning and at night, and Group 2: maintained adequate plaque control levels
      using mechanical methods + chlorohexidine rinse twice daily 10ml in the morning and at the
      night.

      Unified oral hygiene instructions and instructions for each intervention were provided to all
      participants. A 24-hour contact number was provided to each participant, to report any
      concerns, adverse reactions or for any further information. Participants were told that they
      were free to drop out at any time.

      Oral prophylaxis was performed on the same day of recruitment to bring the plaque score to
      almost zero, and the subjects in each group were given either N.sativa oil or chlorohexidine
      according to the blind randomised allocation by a third person. On day zero (baseline) of the
      trial after scaling, and on day 15 at the end of the trial; the following clinical parameters
      were assessed; plaque index (PI) and gingival index (GI) and plaque samples, as well as
      gingival crevicular fluid (GCF) samples, were collected.

      Prior to the study, two dental examiners were calibrated to measure PI and GI, to reduce
      inter-examiner variability.

      The collected data were analyzed using Graphpad PRISM (San Deigo, USA). Non-parametric signed
      Rank tests and parametric t-tests were used, as well as Fisher's exact test for contingency
      analysis. P values were calculated and a p value below 0.05 was deemed as a significant
      difference.
    

Intervention name(s): Nigella Sativa oil; Chlorhexidine mouthwash
Intervention type(s): Other; Drug
Intervention description(s): 5ml Nigella Sativa oil mixed into 5ml water prior to use and rinsed in the mouth for 3 mins and spitted out, used twice a day; morning and evening.; 10ml of chlorohexidine mouthwash used for 3mins and spit out, used twice a day; morning and evening.
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment