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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.

Primary Purpose

Gingivitis

Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Nigella Sativa oil
Chlorhexidine mouthwash
Sponsored by
Ishrat Rahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Nourah bint Abdulrahman University Dental Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 / Nigella Sativa oil / NS

Group 2 / Chlorohexidine / CHX

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Gingival index
Plaque index
IL-6 levels
Measurement of IL-6 in GCF samples
IL-18 levels
Measurement of IL-18 in GCF samples

Secondary Outcome Measures

Bacterial load
Colony forming units (CFU) count
Inhibition of types of bacterial growth
Assessment on the types of bacteria present within the alpha-hemolytic class of oral bacteria

Full Information

First Posted
September 18, 2021
Last Updated
September 25, 2021
Sponsor
Ishrat Rahman
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1. Study Identification

Unique Protocol Identification Number
NCT05069246
Brief Title
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.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
December 24, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ishrat Rahman

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 / Nigella Sativa oil / NS
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 / Chlorohexidine / CHX
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nigella Sativa oil
Intervention Description
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
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Intervention Description
10ml of chlorohexidine mouthwash used for 3mins and spit out, used twice a day; morning and evening.
Primary Outcome Measure Information:
Title
Gingival index
Time Frame
Day 0 and day 15
Title
Plaque index
Time Frame
Day 0 and day 15
Title
IL-6 levels
Description
Measurement of IL-6 in GCF samples
Time Frame
Day 0 and day 15
Title
IL-18 levels
Description
Measurement of IL-18 in GCF samples
Time Frame
Day 0 and day 15
Secondary Outcome Measure Information:
Title
Bacterial load
Description
Colony forming units (CFU) count
Time Frame
Day 0 and day 15
Title
Inhibition of types of bacterial growth
Description
Assessment on the types of bacteria present within the alpha-hemolytic class of oral bacteria
Time Frame
Day 0 and day 15
Other Pre-specified Outcome Measures:
Title
Feedback on any adverse effects and likes/dislikes of the intervention from participants
Description
Questionnaire to report on adverse effects and likes/dislikes of the intervention.
Time Frame
Day 15

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ishrat Rahman
Organizational Affiliation
Princess Nourah Bint Abdulrahman University
Official's Role
Study Director
Facility Information:
Facility Name
Princess Nourah bint Abdulrahman University Dental Clinic
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
At this moment in time, there is no intention or need to make individual participant data available to other researchers.

Learn more about this trial

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.

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