Aphthous UlcerNCT06013202
The Efficacy of Nigella Sativa Oil Mouth Rinse in the Management of Recurrent Minor Aphthous Ulcer
A study testing Nigella Sativa Oil Mouth Rinse and isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) in people with Aphthous Ulcer, run by Nada Sherif at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphthous Ulcer
- What is being tested?
- Nigella Sativa Oil Mouth Rinse and isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Sep 2023to 22 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Nada Mohamed Sherif Aly abdelhamid
Cairo
nada sherif, PHD, 01011922306, nadasherif33@yahoo.com
About this study
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
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
Read the 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.
- Conditions
- Aphthous Ulcer
- Being tested
- Nigella Sativa Oil Mouth Rinse, isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)
- Keywords
- recurrent, aphthous ulcer, minor, nigella sativa, mouth rinse
- Medical subject headings
- Stomatitis, Aphthous, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella Sativa Oil Mouth RinseOther
Nigella Sativa Oil Mouth Rinse
isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)Other
isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (TEST GROUP) Nigella Sativa oil mouth rinse | Experimental | 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. Receives: Other: Nigella Sativa Oil Mouth Rinse |
| Group 2 (CONTROL GROUP) | Active comparator | 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. Receives: Other: isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 week from the baselline
Secondary outcomes (1)
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
Measured: 2 week from the baselline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start22 Sep 2023 (estimated)
- Primary completion12 Apr 2024 (estimated)
- Study completion22 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphthous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a parallel randomized control clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nada Sherif
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Nada Sherif, Ain Shams University
- Investigators
- Nevine Hassan Kheir El Din, Professor, Study director, Ain Shams UniversityAhmed Elsayed Hamed Amr, Lecturer, Study director, Ain Shams UniversityOlfat Gameel Shaker, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013202
- Sponsor's protocol ID
- FDASU-RecID032111
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06013202
- Acronym / sponsor ID
- FDASU-RecID032111
- Conditions
- Aphthous Ulcer
- Keywords
- recurrent, aphthous ulcer, minor, nigella sativa, mouth rinse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nada SherifUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 22 Sep 2023 (estimated)
- Primary completion
- 12 Apr 2024 (estimated)
- Study completion
- 22 Sep 2024 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is designed as a parallel randomized control clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 (TEST GROUP) Nigella Sativa oil mouth rinse | Experimental | Other: Nigella Sativa Oil Mouth RinseTen 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. |
| Group 2 (CONTROL GROUP) | Active comparator | Other: isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nigella Sativa Oil Mouth RinseNigella Sativa Oil Mouth Rinse | Other | Group 1 (TEST GROUP) Nigella Sativa oil mouth rinse |
| isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) | Other | Group 2 (CONTROL GROUP) |
Primary outcome
management of recurrent minor aphthous ulcer as well as patient satisfaction.
Time frame: 2 week from the baselline
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
1 secondary outcome
Evaluate the effect of Nigella Sativa oil mouth rinse biochemically on the salivary TNF-α level.
Time frame: 2 week from the baselline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevine Hassan Kheir El Din, Professor study director
Ain Shams University
Ahmed Elsayed Hamed Amr, Lecturer study director
Ain Shams University
Olfat Gameel Shaker, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nigella Sativa Oil Mouth Rinse and isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) in people with Aphthous Ulcer, run by Nada Sherif at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada Sherif (01011922306, nadasherif33@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
management of recurrent minor aphthous ulcer as well as patient satisfaction. (time frame: 2 week from the baselline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.