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

NCT06792812 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-07-14

No results posted yet for this study

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. 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.

Conditions

  • Mouth Diseases
  • Bleeding Gum
  • Stress

Interventions

DRUG

ginger mouthwash

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.

DRUG

chlorohexidine mouthwash

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Al-Mustansiriyah University

    lead OTHER

Principal Investigators

  • Batool Alshuwaili, B.D.S · Mustansiriyah University-College of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-25
Primary Completion
2025-04-20
Completion
2025-04-20

Countries

  • Iraq

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06792812 on ClinicalTrials.gov