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The Efficacy of Nigella Sativa Oil Mouth Rinse in the Management of Recurrent Minor Aphthous Ulcer

Primary Purpose

Aphthous Ulcer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nigella Sativa Oil Mouth Rinse
isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)
Sponsored by
Nada Sherif
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aphthous Ulcer focused on measuring recurrent, aphthous ulcer, minor, nigella sativa, mouth rinse

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All patients should be free from any systemic disease or Behcet syndrome (Atai et al., 2007). Patients male or female are eligible (Epstein et al., 2018). Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration (Epstein et al., 2018). Patient has only minor aphthous ulcer and its diameter should be less than 1 cm (Atai et al., 2007). It should had not been passed more than 4 days from beginning of their ulcer (Atai et al., 2007). Exclusion Criteria: Patients with poor oral hygiene or not willing to perform oral hygiene measures. Smoking and alcohol use. Pregnant and lactating females. Patients with history of any topical or systemic medication or steroid therapy 1 month prior to the investigation (Chaudhuri et al., 2018).

Sites / Locations

  • Nada Mohamed Sherif Aly abdelhamid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 (TEST GROUP) Nigella Sativa oil mouth rinse

Group 2 (CONTROL GROUP)

Arm Description

Ten patients will receive Nigella Sativa oil mouth rinse. Patients will be asked to use the NS oil mouth rinse (10 ml each 6 hrs.) four times daily . Subjects will be provided with 72 hours supply of the study product. Patients will be instructed to use it for 72 hours with a minimum frequency of four times per day, swished for one minute at each use, in which the first dose was used upon awakening and the last dose just before evening sleep. Patients will be instructed not to use over the counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase.

Ten patients will receive the placebo isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl). Patients will be asked to use it as mouth rinse (10 ml each 6 hrs.) four times daily . Subjects will be provided with 72 hours supply of the study product. Patients will be instructed to use it for 72 hours with a minimum frequency of four times per day, swished for one minute at each use, in which the first dose was used upon awakening and the last dose just before evening sleep. Patients will be instructed not to use over the counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase.

Outcomes

Primary Outcome Measures

management of recurrent minor aphthous ulcer as well as patient satisfaction.
At the screening visit the discomfort and pain severity of patient's symptoms prior to clinical examination will be rated at baseline, Subjects will be provided with 72 hours supply of the study product. The patients will be re-examined after 24, 48, 72 hrs. and day seven ( a week ) from the beginning of the treatment until the complete healing of the recurrent minor aphthous ulcer which estimated by two week from the baseline. All patients should be with Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration

Secondary Outcome Measures

Evaluate the effect of Nigella Sativa oil mouth rinse biochemically on the salivary TNF-α level.
The salivary TNF-α levels in recurrent minor aphthous ulcer patients will be detected by using saliva as a convenient medium, Salivary samples will be collected at baseline before the intervention and after 24, 48, 72 hrs. and day seven ( a week ) from the beginning of the treatment until the complete healing of the recurrent minor aphthous ulcer which estimated by two week from the baseline

Full Information

First Posted
August 21, 2023
Last Updated
August 26, 2023
Sponsor
Nada Sherif
Collaborators
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT06013202
Brief Title
The Efficacy of Nigella Sativa Oil Mouth Rinse in the Management of Recurrent Minor Aphthous Ulcer
Official Title
The Efficacy of Nigella Sativa Oil Mouth Rinse in the Management of Recurrent Minor Aphthous Ulcer A Randomized Controlled Clinical Trial With Biochemical Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 22, 2023 (Anticipated)
Primary Completion Date
April 12, 2024 (Anticipated)
Study Completion Date
September 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nada Sherif
Collaborators
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research aims to investigate the effectiveness of Nigella Sativa Oil Mouth Rinse application both clinically and biochemically as a suitable affordable treatment modality for Management of Recurrent Minor Aphthous Ulcer
Detailed Description
Twenty patients will be selected from the outpatient clinic of the department of Oral Medicine, Periodontology, and Oral diagnosis, Faculty of Dentistry, Ain Shams University and will be divided into two groups (test group and control group), 10 in each group. Ten patients will receive Nigella Sativa oil mouth rinse. Ten patients will receive the placebo isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl). At the screening visit, patient history will be documented, and subjects who met the inclusion/exclusion criteria were asked to complete the survey to determine the severity of their symptoms prior to clinical examination. The oral examination will be a routine visual assessment to document the presence, location and size of an ulcerative oral mucosal lesion. Patients will be asked to use the NS oil mouth rinse (10 ml each 6 hrs.) four times daily. Subjects will be provided with 72 hours supply of the study product. Patients will be instructed to use it for 72 hours with a minimum frequency of four times per day, swished for one minute at each use, in which the first dose was used upon awakening and the last dose just before evening sleep. Patients will be instructed not to use over the counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase. The same procedure will be done in the control group but by using isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl). The patients will be re-examined after 24, 48, 72 hrs. from the beginning of the treatment until the complete healing of the (RAU). When patients completed the follow-up phase after product use, they will be asked to repeat the surveys in which they documented the pain scores and oral symptoms. The ulcer size will be measured using periodontal calibrated probe before treatment and after 24, 48, 72 hrs. of treatment until the complete healing of the (RAU).Clinical photographs of the ulcers will be taken using a digital camera preoperatively and after 24, 48, 72 hrs. of treatment until the complete healing of the (RAU). Patients of discomfort and pain severity will be rated at baseline, 24, 48, 72 hours and day seven after using the study product by numeric rating scale (NRS) and visual analog scale for pain (VAS) since, the association between NRS and VAS would be stronger. The salivary TNF-α levels in RAS patients can be detected by using saliva as a convenient medium and it will be measured prior to the definitive therapy and at the end of using the study product. Distilled water was given to the patients to rinse their oral cavity for 1 minute to remove any debris. Under aseptic conditions, a minimum of 2 ml of saliva will be collected from the patient through 'Spit Technique' after oral rinse with water at room temperature into sterilized tubes every minute for 8-10 minutes. The saliva samples will be collected after one hour or more since the last food intake. The patients will be asked to avoid drinking one hour before sampling. Samples will be immediately frozen at -20°C .The estimation salivary contents of TNF-α will done by enzyme linked immunosorbent assay using a commercial ready-made ELISA kit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphthous Ulcer
Keywords
recurrent, aphthous ulcer, minor, nigella sativa, mouth rinse

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is designed as a parallel randomized control clinical trial
Masking
Participant
Masking Description
single
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (TEST GROUP) Nigella Sativa oil mouth rinse
Arm Type
Experimental
Arm Description
Ten patients will receive Nigella Sativa oil mouth rinse. Patients will be asked to use the NS oil mouth rinse (10 ml each 6 hrs.) four times daily . Subjects will be provided with 72 hours supply of the study product. Patients will be instructed to use it for 72 hours with a minimum frequency of four times per day, swished for one minute at each use, in which the first dose was used upon awakening and the last dose just before evening sleep. Patients will be instructed not to use over the counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase.
Arm Title
Group 2 (CONTROL GROUP)
Arm Type
Active Comparator
Arm Description
Ten patients will receive the placebo isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl). Patients will be asked to use it as mouth rinse (10 ml each 6 hrs.) four times daily . Subjects will be provided with 72 hours supply of the study product. Patients will be instructed to use it for 72 hours with a minimum frequency of four times per day, swished for one minute at each use, in which the first dose was used upon awakening and the last dose just before evening sleep. Patients will be instructed not to use over the counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase.
Intervention Type
Other
Intervention Name(s)
Nigella Sativa Oil Mouth Rinse
Intervention Description
Nigella Sativa Oil Mouth Rinse
Intervention Type
Other
Intervention Name(s)
isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)
Intervention Description
isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)
Primary Outcome Measure Information:
Title
management of recurrent minor aphthous ulcer as well as patient satisfaction.
Description
At the screening visit the discomfort and pain severity of patient's symptoms prior to clinical examination will be rated at baseline, Subjects will be provided with 72 hours supply of the study product. The patients will be re-examined after 24, 48, 72 hrs. and day seven ( a week ) from the beginning of the treatment until the complete healing of the recurrent minor aphthous ulcer which estimated by two week from the baseline. All patients should be with Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration
Time Frame
2 week from the baselline
Secondary Outcome Measure Information:
Title
Evaluate the effect of Nigella Sativa oil mouth rinse biochemically on the salivary TNF-α level.
Description
The salivary TNF-α levels in recurrent minor aphthous ulcer patients will be detected by using saliva as a convenient medium, Salivary samples will be collected at baseline before the intervention and after 24, 48, 72 hrs. and day seven ( a week ) from the beginning of the treatment until the complete healing of the recurrent minor aphthous ulcer which estimated by two week from the baseline
Time Frame
2 week from the baselline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients should be free from any systemic disease or Behcet syndrome (Atai et al., 2007). Patients male or female are eligible (Epstein et al., 2018). Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration (Epstein et al., 2018). Patient has only minor aphthous ulcer and its diameter should be less than 1 cm (Atai et al., 2007). It should had not been passed more than 4 days from beginning of their ulcer (Atai et al., 2007). Exclusion Criteria: Patients with poor oral hygiene or not willing to perform oral hygiene measures. Smoking and alcohol use. Pregnant and lactating females. Patients with history of any topical or systemic medication or steroid therapy 1 month prior to the investigation (Chaudhuri et al., 2018).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nada Sherif
Phone
01011922306
Email
nadasherif33@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevine Hassan Kheir El Din, Professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Elsayed Hamed Amr, Lecturer
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Olfat Gameel Shaker, Professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Nada Mohamed Sherif Aly abdelhamid
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
nada sherif, PHD
Phone
01011922306
Email
nadasherif33@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Efficacy of Nigella Sativa Oil Mouth Rinse in the Management of Recurrent Minor Aphthous Ulcer

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