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.

NCT ID: NCT05069246

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2021-02-28

Brief 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.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nigella Sativa oil

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type: DRUG

10ml of chlorohexidine mouthwash used for 3mins and spit out, used twice a day; morning and evening.

Interventions

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.

Intervention Type: OTHER

Chlorhexidine mouthwash

10ml of chlorohexidine mouthwash used for 3mins and spit out, used twice a day; morning and evening.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ishrat Rahman

OTHER

Sponsor Role: lead

Responsible Party

Ishrat Rahman

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ishrat Rahman

Role: STUDY_DIRECTOR

Princess Nourah Bint Abdulrahman University

Locations

Princess Nourah bint Abdulrahman University Dental Clinic

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

PNU-IRB: 20-0261

Identifier Type: -

Identifier Source: org_study_id