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Clinical Trials/CTRI/2025/12/099937
CTRI/2025/12/099937Not yet recruitingUnknown

Evaluation of the effect of curcumin and chlorhexidine mouthwash on oral biofilm colonization and progression of ventilator associated pneumonia in mechanically ventilated patient: A randomized clinical study

Not provided1 site in 1 country142 target enrollmentStarted: January 5, 2026Last updated:

Trial Snapshot

Phase
Unknown
Status
Not yet recruiting
Enrollment
142
Locations
1
Primary Endpoint
ONSET AND PROGRESSION OF VENTILATOR ASSOCIATED PNEUMONIA IN MECHANICALLY VENTILATED PATIENTS

Study Overview

Brief Summary

Ventilator-associated pneumonia  is a common hospital-acquired infection occurring in mechanically ventilated ICU patients, mainly due to aspiration of oropharyngeal secretions and increased bacterial colonization. Oral hygiene plays a crucial role in reducing the microbial load and preventing the development of VAP. Chlorhexidine is widely used as a chemical plaque control agent due to its broad-spectrum antimicrobial activity, whereas curcumin, a natural compound derived from Curcuma longa, possesses anti-inflammatory, antioxidant, and antimicrobial properties and has shown potential as an effective oral care agent.

This randomized clinical trial aims to compare the effect of curcumin mouthwash and chlorhexidine mouthwash on the incidence and progression of ventilator-associated pneumonia in mechanically ventilated ICU patients. A total of 142 participants will be randomly allocated into two groups: Group 1 will receive chlorhexidine mouthwash as part of oral care, and Group 2 will receive curcumin mouthwash. Oral assessments, plaque index, Beck Oral Assessment Scale, and modified Clinical Pulmonary Infection Score  will be recorded at baseline, day 4, and day 8. The study will also evaluate the influence of periodontal status on VAP progression. Findings may provide evidence for integrating herbal alternatives like curcumin into ICU oral care protocols.

Primary Outcome Incidence of ventilator associated pneumonia measured using Modified Clinical Pulmonary Infection Score at baseline day 4 and day 8.

Secondary Outcomes Plaque Index Silness and Loe 1964 measured at baseline day 4 and day 8. Beck Oral Assessment Scale scores measured at baseline day 4 and day 8. Change in periodontal parameters including clinical attachment level and probing pocket depth. Effect of periodontal status on progression of ventilator associated pneumonia.

Group 1 Chlorhexidine Mouthwash Intervention 15 ml of chlorhexidine mouthwash applied using sterile cotton swabs. Frequency twice daily. Duration from admission within 24 hours until day 8 or extubation. Procedure oral cavity gingiva and tongue will be cleaned secretions will be suctioned lips will be lubricated.

Group 2 Curcumin Mouthwash Intervention 15 ml of curcumin mouthwash applied using sterile cotton swabs. Frequency twice daily. Duration from admission within 24 hours until day 8 or extubation. Procedure same oral care protocol as group 1.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
19.00 Year(s) to 59.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • No history of pneumonia at the time of admission or prior history of pulmonary disease No allergy to curcumin No covid 19 infection Patient willing to participate.

Exclusion Criteria

  • Facial fractures Pneumonia at the time of admission Patients not willing to give consent Fever greater than 38.50 Covid 19 infection APACHE 2 score greater than 30 More than three attempts at intubation.

Outcomes

Primary Outcomes

ONSET AND PROGRESSION OF VENTILATOR ASSOCIATED PNEUMONIA IN MECHANICALLY VENTILATED PATIENTS

Time Frame: the outcome will be assesed on day 0, day 3, day 8

Secondary Outcomes

  • Secondary Outcomes(Plaque Index)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Shubhi Katiyar

Faculty of Dental Sciences, King Georges Medical University

Study Sites (1)

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