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.

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Other: Nigella Sativa oil; Drug: Chlorhexidine mouthwash

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Princess Nourah bint Abdulrahman University Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• At least 20 natural teeth
• Patients with moderate to severe gingivitis
• No tooth attachment loss

Exclusion Criteria:

• Periodontitis
• Cigarette smokers
• Antibiotic therapy (within the last 3 months)
• Systemic diseases
• Pregnant women
• Lactating women
• Current orthodontic treatment
• Using an intra-oral artificial prosthesis
• Using other chemical agents as a mouthwash

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 / Nigella Sativa oil / NS; Group 1- Nigella Sativa (NS) N. sativa oil (Al-Hussan Food Products Factory, Riyadh, Kingdom of Saudi Arabia), which was brought from the local market in Riyadh. Each participant was given a 3 weeks supply of oil, and a sterile plastic 15ml graduated measuring cap. They were asked to measure 5ml of oil into the cap and add 5ml of normal drinking water to this and rinse their mouth for 3mins with this solution and spit it out at the end. This was done morning and evening for 14 days. 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 (after brushing/breakfast in the morning, and after brushing and before sleeping at night). Unified oral hygiene instructions and instructions for each intervention were provided to all participants.	Other: Nigella Sativa oil; 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.
Active Comparator: Group 2 / Chlorohexidine / CHX; Group 2- Chlorohexidine (CHX). Chlorohexidine (Middle East Pharmaceutical Industries Ltd, Riyadh, Kingdom of Saudi Arabia). Each participant was given a 3 week supply of chlorohexidine. They were asked to use 10ml of CHX morning and evening, rinsing their mouth for 3 mins and then spit it out at the end. This was done morning and evening for 14 days. Group2: maintained adequate plaque control levels using mechanical methods + chlorohexidine rinse twice daily 10ml in the morning and at the night (after brushing/breakfast in the morning, and after brushing and before sleeping at night). Unified oral hygiene instructions and instructions for each intervention were provided to all participants.	Drug: Chlorhexidine mouthwash; 10ml of chlorohexidine mouthwash used for 3mins and spit out, used twice a day; morning and evening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival index		Day 0 and day 15
Plaque index		Day 0 and day 15
IL-6 levels	Measurement of IL-6 in GCF samples	Day 0 and day 15
IL-18 levels	Measurement of IL-18 in GCF samples	Day 0 and day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial load	Colony forming units (CFU) count	Day 0 and day 15
Inhibition of types of bacterial growth	Assessment on the types of bacteria present within the alpha-hemolytic class of oral bacteria	Day 0 and day 15

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feedback on any adverse effects and likes/dislikes of the intervention from participants	Questionnaire to report on adverse effects and likes/dislikes of the intervention.	Day 15

Collaborators and Investigators

• Sponsor: Ishrat Rahman
• Investigators: Study Director: Ishrat Rahman, Princess Nourah Bint Abdulrahman University

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): December 24, 2020
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: PNU-IRB: 20-0261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this moment in time, there is no intention or need to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No