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

NCT ID: NCT06875440

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-22
• Study Completion Date: 2025-04-20

Brief Summary

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

Detailed Description

This research was structured as a double-blind, randomized clinical trial to assess the effectiveness of CHX and green tea mouthwash on periodontal health in patients with gingivitis. 84 patients from the Department of Periodontics at Broujerd Dental School of the Islamic Azad University of Medical Sciences were chosen for the study. Before the commencement of the trial, various clinical periodontal parameters, such as plaque index, bleeding on probing, gingival index, probing depth, and clinical attachment level, were measured in six different areas of the tooth surface. Subsequently, scaling and root planning were carried out, and oral hygiene practices were enhanced for all participants. The participants were then randomly divided into three groups: Group A, CHX, and Group B, which was provided with Green tea mouthwash two times daily. After three months, the clinical periodontal parameters were reevaluated. Furthermore, to compare the total PMN and TAC levels in saliva before and after the administration of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at the beginning and end of the study for analysis using UV-spectrophotometric methods. The selection criteria for eligible participants in this study were also clearly defined.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CHX mouthwash

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.

Group Type: EXPERIMENTAL

CHX mouthwash

Intervention Type: 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.

Green Tea mouthwash

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.

Group Type: ACTIVE_COMPARATOR

CHX mouthwash

Intervention Type: 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.

Interventions

CHX mouthwash

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.

Intervention Type: DRUG

Other Intervention Names

Green tea mouthwash

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Islamic Azad University, Sanandaj

OTHER

Sponsor Role: lead

Responsible Party

Amirhossein Farahmand

Periodontist, Associate Professor, Department of Periodontics, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran, Affiliation: Islamic Azad University, Tehran

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amirhossein Farahmand

Tehran, Tehran, Iran., Iran

Countries

Iran

Other Identifiers

1346

Identifier Type: -

Identifier Source: org_study_id