A Comparison of Chlorhexidine and Green Tea Mouthwash in Patients With Gingivitis and Their Salivary Neutrophil and TAC Levels

NCT06875440 | Enrolling By Invitation

• 1 other identifier: 1346
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

A Comparison of Chlorhexidine and Green Tea Mouthwash in Patients With Gingivitis and Their Salivary Neutrophil and TAC Levels.

Conditions

Periodontal Diseases

Keywords

Gingivitis, Saliva, Green tea, Chlorhexidine, Neutrophil

Outcome Measures

Primary Outcomes (1)

• Total Neutrophil level of saliva

  UV-spectrophotometry was employed to assess the overall Neutrophil and TAC in saliva before and after consuming these supplements, as well as in individuals who were not administered any medication. A total of 2 ml of non-stimulated saliva was collected from each participant at the commencement and conclusion of the study for analysis using UV-spectrophotometric techniques.

  3 months

Secondary Outcomes (1)

• Plaque index

  3 months

Study Arms (2)

CHX mouthwash

EXPERIMENTAL

Participants in Group A were administered CHX two times daily throughout the two-month study period. After the study concluded, the clinical periodontal parameters were reevaluated to assess any potential impact of the supplements on oral health.. To compare the total PMN level in saliva before and after the consumption of the Green tea mouthwash, as well as in individuals who did not receive any form of medication, 2 ml of non-stimulated saliva was collected from each participant at the commencement and conclusion of the study. These samples were then analyzed using UV-spectrophotometric methods to determine any variations in Neutrophil levels.

Drug: CHX mouthwash

Green Tea mouthwash

ACTIVE COMPARATOR

Participants in Group B were administered Green tea two times daily throughout the two-month study period. After the study concluded, the clinical periodontal parameters were reevaluated to assess any potential impact of the supplements on oral health.. To compare the total PMN level in saliva before and after the consumption of the CHX mouthwash, as well as in individuals who did not receive any form of medication, 2 ml of non-stimulated saliva was collected from each participant at the commencement and conclusion of the study. These samples were then analyzed using UV-spectrophotometric methods to determine any variations in Neutrophil levels.

Drug: CHX mouthwash

Interventions

CHX mouthwash DRUG

A total of 84 individuals diagnosed with gingivitis were selected for this study. These participants were randomly assigned to two different groups. The purpose of the study was to measure the periodontal parameters of the two molars adjacent to the mandible using a periodontal probe. All of the patients received scaling and root planing (SRP) as part of their treatment. However, the treatment groups differed in terms of the supplements they received. Group A was given a twice-daily dose of CHX, while Group B received a daily dose of Green tea. In addition to this, 2 ml of unstimulated saliva was collected from each patient both before and after 2 months. The purpose of collecting the saliva samples was to evaluate the total Neutrophil level and determine if there were any changes over time.

Also known as: Green tea mouthwash

CHX mouthwash; Green Tea mouthwash

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a minimum of 20 natural teeth; a mean plaque index (PI) of at least 1.5, (10); a mean gingival index (GI) of at least 1.0 (Patients with a gingival index score of ≥1 at more than 60% of sites

You may not qualify if:

• with systemic diseases, those who had undergone antibiotic therapy in the past three months, and anyone who had received periodontal treatment within the last six months. Participants diagnosed with aggressive periodontitis, individuals with known allergies to statin medications, and those currently undergoing statin treatment or using medications that may affect periodontal health were also not eligible. Furthermore, individuals who are immunocompromised, those who use tobacco products, and lactating or pregnant women were excluded from participation.

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

Study Sites (1)

Amirhossein Farahmand

Tehran, Tehran, Iran., 1947833113, Iran

Location

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was carried out utilizing a double-blind approach. To guarantee objectivity, all three groups - the CHX group, the Green tea group, and the control group - received medications that were indistinguishable in terms of appearance, packaging, and color. Additionally, to minimize any potential bias, a clinician who had no association with the research labeled the medications as A and B, based on their content, and then distributed them among the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontist, Associate Professor, Department of Periodontics, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran, Affiliation: Islamic Azad University, Tehran

Model Details: Parallel Assignment, Randomized, Double-blind, Controlled design.

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: September 22, 2024
• Primary Completion: January 29, 2025
• Study Completion: April 20, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

IR (1)