Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05069246 |
| Other study ID # |
PNU-IRB: 20-0261 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
December 8, 2020 |
| Est. completion date |
February 28, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Princess Nourah Bint Abdulrahman University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
