The Impact of Ginger Mouthwash on the Pregnant Women With Stress and Gingivitis

NCT06792812 | Completed Phase 2 DMC

• 1 other identifier: MUOSU-202125
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Mouth Diseases; Bleeding Gum; Stress

Keywords

gingivitis; stress; pregnancy; ginger mouthwash

Outcome Measures

Primary Outcomes (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).

  0-7 days

Secondary Outcomes (1)

• Secondary Outcome Measure

  0-7 days

Study Arms (3)

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.

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.

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.

Drug: Placebo

Interventions

ginger mouthwash DRUG

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.

ginger mouthwash

chlorohexidine mouthwash DRUG

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.

chlorohexidine mouthwash

Placebo DRUG

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.

placepo

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Mustansiriyah University

Baghdad, Iraq

Location

MeSH Terms

Conditions

Mouth Diseases; Gingival Hemorrhage; Gingivitis

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Oral Hemorrhage; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Batool Alshuwaili, B.D.S

  Al-Mustansiriyah University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: the products will be packaged in such a way that they are not recognizable by the operator or the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator according to the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: January 27, 2025
• Study Start: January 25, 2025
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

IR (1)