Mouth DiseasesPhase 2NCT06792812
The Impact of Ginger Mouthwash on the Pregnant Women With Stress and Gingivitis
A Phase 2 study testing ginger mouthwash and chlorohexidine mouthwash in people with Mouth Diseases and Bleeding Gum, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
The study aims to determine ginger mouthwash's impact on gingival health, IL-6, cortisol, LF, and 8-OHdG levels in pregnant women with stress and gingivitis compared to CHX and distilled water. Objectives: 1. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mouth Diseases, Bleeding Gum, Stress
- What is being tested?
- ginger mouthwash and chlorohexidine mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIraq
- Study dates
- 25 Jan 2025to 20 Apr 2025
- Phase
- Phase 2
- 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant with gingivitis with impact periodontium.
- Pregnant with stress.
- Pregnant in 5,6,7 months.
- Pregnant in age (20-30) years old.
- Good general health without systemic disease.
- The presence of at least 20 or more natural teeth.
- No antibiotic therapy has been received in the last 3 months.
Who cannot join
- currently use any mouthwash.
- Pregnant who rejects the form of informed approval.
- Pregnant with dental implants and orthodontic or prosthodontic appliances or any retentive factor of dental plaque.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Ginger Mouthwash on the Pregnant Women With Stress and Gingivitis by Measuring Different Salivary Biomarkers Levels (Randomized Clinical Trial)
The study aims to determine ginger mouthwash's impact on gingival health, IL-6, cortisol, LF, and 8-OHdG levels in pregnant women with stress and gingivitis compared to CHX and distilled water.
Objectives:
- Evaluate the clinical efficiency of ginger mouth rinse for 7 days to control gingival inflammation by measuring the clinical periodontal parameters, Plaque Index (PI), Gingival Index (GI), and Bleeding on probing (BOP) in comparison with CHX and placebo mouth rinses in pregnant women who have stress and gingivitis.
- Measuring salivary IL_6, Cortisol, LF, and 8-OHdG levels by Enzyme-linked immunosorbent assay (ELISA) at the baseline visit before and after 7 days of using ginger mouth rinse compared to CHX and placebo mouth rinses.
- Assessment of participants' feedback regarding ginger, CHX, and placebo mouth rinses after 7 days of use by Visual Analog Scale (VAS) questionnaire.
- correlate IL_6, Cortisol, LF and 8-OHdG salivary levels with clinical periodontal parameters (GI, BOP, PI) to assess their relationship in pregnant women with stress and gingivitis.
Read the detailed description
54 pregnant with stress will be enrolled, who show with gingivitis The investigator assesses symptoms of stress using a translated Arabic version of Perceived Stress Scale (PSS) Each pregnant answers following questions Questions never almost never sometimes fairly often very often
- In the last month how often have you been upset because of something that happened unexpectedly?
- In the last month, how often have you felt that you were unable to control the important things in your life
- In the last month, how often have you felt nervous and stressed?
- In the last month, how often have you felt confident about your ability to handle your personal problems?
- In the last month, how often have you felt that things were going your way?
- In the last month, how often have you found that you could not cope with all the things that you had to do?
- In the last month, how often have you been able to control irritations in your life?
- In the last month, how often have you felt that you were on top of things
- In the last month, how often have you been angered because of things that happened that were outside of your control?
- In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?
For each question choose from the following alternatives:
0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
- Scores ranging from 0-13 would be considered low stress.
- Scores ranging from 14-26 would be considered moderate stress.
- Scores ranging from 27-40 would be considered high perceived stress.
A triple-blind, randomized parallel 3-arms clinical trial include using the following mouth rinses, 0.12% CHX (KIN Gingival, KIN, Barcelona, Spain) as positive-control, distilled water (placebo, nonactive control) with food additives (to blind the subjects and examiner) and ginger mouthwash (Pasta del Capitano, Italy)
The examiner will perform randomization for the enrollment patients in 3 groups. Each group will be assigned a letter (A, B, or C) corresponding to the intervention used. Random numbers were generated and used to re-sort the order of the groups and participants (n=54), who will be distributed into designated groups, each group received a similar number of subjects (n=18) , by using a Microsoft Excel random table (Microsoft Office 2021, Microsoft Corporation, USA). Then, coded bottles with the interventions will be delivered to the participants together with instructions for use.
The participants will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. Discontinuation of the mouthwash will be advised in cases of any allergic reaction. All participants will be received a toothbrush with medium-hardness bristles and a toothpaste, and All participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation Saliva collection for IL-6, cortisol, lactoferrin, and 8-OHdG measurement then clinical periodontal parameters examination starting with gingival index designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency and bleeding on probing. A periodontal probe will be runned along the gingival margin. The gingiva surrounding the tooth is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial papilla and lingual marginal gingiva.
Followed by dryness and wait then measurement of BOP for the six surfaces of all teeth except wisdom teeth through gently inserting the periodontal probe to the depth of the gingival sulcus then removed coronally and waited for 30 s to observe the presence of bleeding (0=no bleeding, 1=presence of bleeding)
Then finally followed by the Plaque Index :
A periodontal probe may be used to confirm the presence of plaque. Scores were recorded on four surfaces; distal, mid, and mesial points on the facial (buccal) and lingual (palatal) aspects. as follows:
0- ne plaque (left blank)
1- plaque present ( recorded)
First visit after 7 days, from the baseline visit. Saliva collection and clinical periodontal parameters scoring (GI, BOP, PI) will be performed again as described at baseline visit. The mouthwash bottles will be retrieved, and the remaining volume will be determining to further evaluate the compliance with mouth rinsing. For the purpose of self-assessment, a visual analog scale (VAS)- score based questionnaire was filled out by each participant at the end of the trial to evaluate the intervention. The questionnaire and method of data interpretation were adopted and modified from a previous study
- Conditions
- Mouth Diseases, Bleeding Gum, Stress
- Being tested
- ginger mouthwash, chlorohexidine mouthwash, Placebo
- Keywords
- gingivitis, stress, pregnancy, ginger mouthwash
- Medical subject headings
- Mouth Diseases, Gingival Hemorrhage, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ginger mouthwashDrug
contain Sulfetal Zn® (Zinc Coco Sulphate) has a cleansing and antibacterial action and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days.
chlorohexidine mouthwashDrug
Subjects will then be given Chlorhexidine 0.12%mouthwash, as an active comparator, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days.
PlaceboDrug
Subjects will be given the nonactive control, distilled water, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days.
| Study group | Role | What they receive |
|---|---|---|
| ginger mouthwash | Experimental | Ginger mouthwash (Pasta del Capitano) Participants will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE) and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. Receives: Drug: ginger mouthwash |
| chlorohexidine mouthwash | Experimental | Chlorhexidine 0.12% Participants will be given as positive control the Chlorhexidine 0.12%, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE) and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. Receives: Drug: chlorohexidine mouthwash |
| placepo | Experimental | Placebo Product Participants will be given distilled water, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Measuring Change in the clinical periodontal parameter (Bleeding on Probing) Subjects will undergo the measurement bleeding on probing for the six surfaces of all teeth except wisdom teeth through gently inserting the periodontal probe to the depth of the gingival sulcus then removed coronally and waited for 30 s to observe the presence of bleeding (0=no bleeding, 1=presence of bleeding).
Measured: 0-7 days
Secondary outcomes (1)
Secondary Outcome Measure
Measurement changes in salivary Interleukin 6 by using Enzyme-linked immunosorbent assay (ELISA) before and after using mouthwash by saliva collection before and after using mouthwash Sensitivity 0.94 pg/mL Detection Range 1.56-100 pg/mL
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start25 Jan 2025
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pregnant with stress and gingivitis, will be selected and enrolled in this study. Subsequently, subjects will be equally divided and randomly allocated into three groups, each group receiving a similar number of subjects (n=18)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Batool Abbas Tareq, Al-Mustansiriyah University
- Investigators
- Batool Alshuwaili, B.D.S, Principal investigator, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792812
- Sponsor's protocol ID
- MUOSU-202125
- Status last verified
- Jul 2025
- First submitted
- 9 Oct 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ginger Mouthwash on the Pregnant Women With Stress and Gingivitis by Measuring Different Salivary Biomarkers Levels (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06792812
- Acronym / sponsor ID
- MUOSU-202125
- Conditions
- Mouth Diseases, Bleeding Gum, Stress
- Keywords
- gingivitis, stress, pregnancy, ginger mouthwash
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 27 Jan 2025 (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.
The study aims to determine ginger mouthwash's impact on gingival health, IL-6, cortisol, LF, and 8-OHdG levels in pregnant women with stress and gingivitis compared to CHX and distilled water.
Objectives:
- Evaluate the clinical efficiency of ginger mouth rinse for 7 days to control gingival inflammation by measuring the clinical periodontal parameters, Plaque Index (PI), Gingival Index (GI), and Bleeding on probing (BOP) in comparison with CHX and placebo mouth rinses in pregnant women who have stress and gingivitis.
- Measuring salivary IL_6, Cortisol, LF, and 8-OHdG levels by Enzyme-linked immunosorbent assay (ELISA) at the baseline visit before and after 7 days of using ginger mouth rinse compared to CHX and placebo mouth rinses.
- Assessment of participants' feedback regarding ginger, CHX, and placebo mouth rinses after 7 days of use by Visual Analog Scale (VAS) questionnaire.
- correlate IL_6, Cortisol, LF and 8-OHdG salivary levels with clinical periodontal parameters (GI, BOP, PI) to assess their relationship in pregnant women with stress and gingivitis.
Detailed description
54 pregnant with stress will be enrolled, who show with gingivitis The investigator assesses symptoms of stress using a translated Arabic version of Perceived Stress Scale (PSS) Each pregnant answers following questions Questions never almost never sometimes fairly often very often
- In the last month how often have you been upset because of something that happened unexpectedly?
- In the last month, how often have you felt that you were unable to control the important things in your life
- In the last month, how often have you felt nervous and stressed?
- In the last month, how often have you felt confident about your ability to handle your personal problems?
- In the last month, how often have you felt that things were going your way?
- In the last month, how often have you found that you could not cope with all the things that you had to do?
- In the last month, how often have you been able to control irritations in your life?
- In the last month, how often have you felt that you were on top of things
- In the last month, how often have you been angered because of things that happened that were outside of your control?
- In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?
For each question choose from the following alternatives:
0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
- Scores ranging from 0-13 would be considered low stress.
- Scores ranging from 14-26 would be considered moderate stress.
- Scores ranging from 27-40 would be considered high perceived stress.
A triple-blind, randomized parallel 3-arms clinical trial include using the following mouth rinses, 0.12% CHX (KIN Gingival, KIN, Barcelona, Spain) as positive-control, distilled water (placebo, nonactive control) with food additives (to blind the subjects and examiner) and ginger mouthwash (Pasta del Capitano, Italy)
The examiner will perform randomization for the enrollment patients in 3 groups. Each group will be assigned a letter (A, B, or C) corresponding to the intervention used. Random numbers were generated and used to re-sort the order of the groups and participants (n=54), who will be distributed into designated groups, each group received a similar number of subjects (n=18) , by using a Microsoft Excel random table (Microsoft Office 2021, Microsoft Corporation, USA). Then, coded bottles with the interventions will be delivered to the participants together with instructions for use.
The participants will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. Discontinuation of the mouthwash will be advised in cases of any allergic reaction. All participants will be received a toothbrush with medium-hardness bristles and a toothpaste, and All participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation Saliva collection for IL-6, cortisol, lactoferrin, and 8-OHdG measurement then clinical periodontal parameters examination starting with gingival index designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency and bleeding on probing. A periodontal probe will be runned along the gingival margin. The gingiva surrounding the tooth is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial papilla and lingual marginal gingiva.
Followed by dryness and wait then measurement of BOP for the six surfaces of all teeth except wisdom teeth through gently inserting the periodontal probe to the depth of the gingival sulcus then removed coronally and waited for 30 s to observe the presence of bleeding (0=no bleeding, 1=presence of bleeding)
Then finally followed by the Plaque Index :
A periodontal probe may be used to confirm the presence of plaque. Scores were recorded on four surfaces; distal, mid, and mesial points on the facial (buccal) and lingual (palatal) aspects. as follows:
0- ne plaque (left blank)
1- plaque present ( recorded)
First visit after 7 days, from the baseline visit. Saliva collection and clinical periodontal parameters scoring (GI, BOP, PI) will be performed again as described at baseline visit. The mouthwash bottles will be retrieved, and the remaining volume will be determining to further evaluate the compliance with mouth rinsing. For the purpose of self-assessment, a visual analog scale (VAS)- score based questionnaire was filled out by each participant at the end of the trial to evaluate the intervention. The questionnaire and method of data interpretation were adopted and modified from a previous study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- pregnant with stress and gingivitis, will be selected and enrolled in this study. Subsequently, subjects will be equally divided and randomly allocated into three groups, each group receiving a similar number of subjects (n=18)
| Arm | Type | Receives |
|---|---|---|
| ginger mouthwash | Experimental | Drug: ginger mouthwashGinger mouthwash (Pasta del Capitano) Participants will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE) and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. |
| chlorohexidine mouthwash | Experimental | Drug: chlorohexidine mouthwashChlorhexidine 0.12% Participants will be given as positive control the Chlorhexidine 0.12%, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE) and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. |
| placepo | Experimental | Drug: PlaceboPlacebo Product Participants will be given distilled water, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant with gingivitis with impact periodontium.
- Pregnant with stress.
- Pregnant in 5,6,7 months.
- Pregnant in age (20-30) years old.
- Good general health without systemic disease.
Key exclusion criteria (3 listed)
- currently use any mouthwash.
- Pregnant who rejects the form of informed approval.
- Pregnant with dental implants and orthodontic or prosthodontic appliances or any retentive factor of dental plaque.
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 |
|---|---|---|
| ginger mouthwashcontain Sulfetal Zn® (Zinc Coco Sulphate) has a cleansing and antibacterial action and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. | Drug | ginger mouthwash |
| chlorohexidine mouthwashSubjects will then be given Chlorhexidine 0.12%mouthwash, as an active comparator, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. | Drug | chlorohexidine mouthwash |
| PlaceboSubjects will be given the nonactive control, distilled water, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. | Drug | placepo |
Primary outcome
Primary Outcome Measure
Time frame: 0-7 days
Measuring Change in the clinical periodontal parameter (Bleeding on Probing) Subjects will undergo the measurement bleeding on probing for the six surfaces of all teeth except wisdom teeth through gently inserting the periodontal probe to the depth of the gingival sulcus then removed coronally and waited for 30 s to observe the presence of bleeding (0=no bleeding, 1=presence of bleeding).
1 secondary outcome
Secondary Outcome Measure
Time frame: 0-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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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.
Batool Alshuwaili, B.D.S principal investigator
Al-Mustansiriyah University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ginger mouthwash and chlorohexidine mouthwash in people with Mouth Diseases and Bleeding Gum, run by Al-Mustansiriyah University at 1 site in Iraq.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jul 2025. 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 Iraq. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 0-7 days). 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 14 Jul 2025.