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

NCT06013202 | Unknown DMC

• 1 other identifier: FDASU-RecID032111
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Aphthous Ulcer

Keywords

recurrent; aphthous ulcer; minor; nigella sativa; mouth rinse

Outcome Measures

Primary Outcomes (1)

• 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

  2 week from the baselline

Secondary Outcomes (1)

• Evaluate the effect of Nigella Sativa oil mouth rinse biochemically on the salivary TNF-α level.

  2 week from the baselline

Study Arms (2)

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.

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.

Other: isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)

Interventions

Nigella Sativa Oil Mouth Rinse OTHER

Nigella Sativa Oil Mouth Rinse

Group 1 (TEST GROUP) 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)

Group 2 (CONTROL GROUP)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nada Sherif: lead
• Ain Shams University: collaborator

Study Sites (1)

Nada Mohamed Sherif Aly abdelhamid

Cairo, Egypt

Location

MeSH Terms

Conditions

Stomatitis, Aphthous; Recurrence

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Nevine Hassan Kheir El Din, Professor

  Ain Shams University

  STUDY DIRECTOR

• Ahmed Elsayed Hamed Amr, Lecturer

  Ain Shams University

  STUDY DIRECTOR

• Olfat Gameel Shaker, Professor

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Nada Sherif

CONTACT

01011922306; nadasherif33@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investiagator

Model Details: This study is designed as a parallel randomized control clinical trial

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 28, 2023
• Study Start: September 22, 2023
• Primary Completion: April 12, 2024
• Study Completion: September 22, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)