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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Iraq1 site
  • Mustansiriyah University

    Baghdad

Other trials in Iraq

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:

  1. 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.
  2. 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.
  3. Assessment of participants' feedback regarding ginger, CHX, and placebo mouth rinses after 7 days of use by Visual Analog Scale (VAS) questionnaire.
  4. 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

  1. In the last month how often have you been upset because of something that happened unexpectedly?
  2. In the last month, how often have you felt that you were unable to control the important things in your life
  3. In the last month, how often have you felt nervous and stressed?
  4. In the last month, how often have you felt confident about your ability to handle your personal problems?
  5. In the last month, how often have you felt that things were going your way?
  6. In the last month, how often have you found that you could not cope with all the things that you had to do?
  7. In the last month, how often have you been able to control irritations in your life?
  8. In the last month, how often have you felt that you were on top of things
  9. In the last month, how often have you been angered because of things that happened that were outside of your control?
  10. 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

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 groups in NCT06792812
Study groupRoleWhat they receive
ginger mouthwashExperimentalGinger 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 mouthwashExperimentalChlorhexidine 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
placepoExperimentalPlacebo 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.

  1. 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)
  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.

  1. First posted27 Jan 2025
  2. Study start25 Jan 2025
  3. Primary completion20 Apr 2025
  4. Study completion20 Apr 2025

Resources

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)
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

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.

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