Clinical and Microbiological Evaluation Of The Efficacy Of Herbal Mouthwashes in Gingivitis

NCT ID: NCT06904742

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2024-07-15

Brief Summary

Plaque-induced gingivitis is a clinical condition that appears to cause persistent inflammation in gingiva. It is a preliminary cause to periodontitis but it can be inverted to address the risk of periodontitis development. This randomize controlled clinical trial (RCT) aims to clinically and microbiologically evaluate the effectiveness of different herbal mouthwashes as an adjunct treatment to non-surgical periodontal therapy (NSPT) in patients with gingivitis. A total of 52 patients diagnosed with gingivitis were incorporated into the RCT and categorized into four groups as follows: Tea tree oil (Tebodont®), thyme hydrosol (Arifoglu®), essential oil (Listerine®), and placebo. The patients were advised to wash with15 ml of prescribed mouthwash twice a day for a period of 3rd months after NSPT. Clinical periodontal measurements; including plaque index (PI), gingival index (GI) and probing pocket depth (PPD) and microbiological sampling, were performed before enrollment and in 3rd months. Plaque samples were examined by quantitative polymerase chain reaction(qPCR).

Detailed Description

This randomize controlled clinical trial aims to clinically and microbiologically evaluate the effectiveness of different herbal mouthwashes as an adjunct treatment to non- surgical periodontal therapy in patients with gingivitis.

Conditions

Periodontal Diseases

Study Design

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

Study Groups

Tea Tree Oil Mouthwash Group

Patients were randomized to receive the respective mouthwashes. Participants were instructed to use 15 mL of mouthwash twice-daily for one minute per application and to avoid from rinsing or consuming food for 30 minutes post-application.

Group Type: ACTIVE_COMPARATOR

Tea tree oil

Intervention Type: DRUG

Our study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily . Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s. In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses.

non-alcohol EO mouthwash group

Group II; non-alcohol EO mouthwash group, patients who were administered non-alcohol essential oil mouthwash (15 mL of (Listerine Total Care Zero Mouthwash, Listerine ® for 1 min) (n=13)

Group Type: ACTIVE_COMPARATOR

LISTERINE ZERO Alcohol Mouthwash COOL MINT

Intervention Type: DRUG

Our study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily. Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s . In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses.

thyme-containing hydrosol group

Group III; thyme-containing hydrosol group, of patients who were administered thyme-containing Mouthwash (15 mL of thyme hydrosol, Arifoğlu ®for 1 min) (n = 13).

Group Type: ACTIVE_COMPARATOR

Thyme oil hydrosol

Intervention Type: DRUG

Our study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily (Santi et al., 2019). Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s (Santi et al., 2019). In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses.

Control group

placebo group, patients who were administered placebo mouthwash (15 mL of placebo mouthwash for 1 min.) (n=13)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo mouthwash had been used in 13 patients for 3 months

Interventions

Tea tree oil

Our study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily . Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s. In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses.

Intervention Type: DRUG

Thyme oil hydrosol

Our study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily (Santi et al., 2019). Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s (Santi et al., 2019). In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses.

Intervention Type: DRUG

LISTERINE ZERO Alcohol Mouthwash COOL MINT

Our study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily. Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s . In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses.

Intervention Type: DRUG

Placebo

Placebo mouthwash had been used in 13 patients for 3 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• According to EFP in 2017, gingivitis patients with a PPD ≤3 mm, BOP in the whole mouth ≥ % 10 and no radiological bone loss
• Having ≥ 20 teeth
• Male or female ≥ 18 years old
• Systemically healthy patients

Exclusion Criteria

• Using of any antioxidant or antimicrobial agent in the last 6 months

•. Smoking

• Pregnancy
• Alcoholism

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

Sponsors

Altinbas University

OTHER

Sponsor Role: lead

Responsible Party

Candan Pelin

dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Altinbas University

Istanbul, Bakirkoy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/213

Identifier Type: -

Identifier Source: org_study_id