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

NCT06904742 | Completed Phase 4 DMC

• 1 other identifier: 2023/213
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Periodontal Diseases

Keywords

gingivitis; essential oil; tea tree oil; thyme; qPCR

Outcome Measures

Primary Outcomes (3)

• Reduction in PI

  PI is the amount of microbial dental plaque assesed on 6 sites of per tooth. In addition to mechanical plaque control, plaque index was our primary evaluation of the mechanism of action of mouthwashes in our study.

  Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month

• Reduction in GI

  GI introduce system for the assessment of gingival condition. For the evaluation of the index, 6 points (mesiobuccal, midpoint, distobuccal; mesiopalatinal, midpoint, distopalatinal) are examined according to the presence of bleeding that occurs after the examination with the probe and index values between 0-3 are given.

  Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month

• Reduction in Bleeding on Probing

  Bleeding on probing is one of the important parameters in the diagnosis of gingivitis, reduction in bleeding on probing is the primary outcomed.

  Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month

Secondary Outcomes (1)

• Reduction in PPD

  Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month

Study Arms (4)

Tea Tree Oil Mouthwash Group

ACTIVE COMPARATOR

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.

Drug: Tea tree oil

non-alcohol EO mouthwash group

ACTIVE COMPARATOR

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)

Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT

thyme-containing hydrosol group

ACTIVE COMPARATOR

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).

Drug: Thyme oil hydrosol

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tea tree oil 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.

Tea Tree Oil Mouthwash Group

Thyme oil hydrosol 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.

thyme-containing hydrosol group

LISTERINE ZERO Alcohol Mouthwash COOL MINT 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

Placebo DRUG

Placebo mouthwash had been used in 13 patients for 3 months

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Using of any antioxidant or antimicrobial agent in the last 6 months
• . Smoking
• Pregnancy
• Alcoholism

Sponsors & Collaborators

• Altinbas University: lead

Study Sites (1)

Altinbas University

Istanbul, Bakirkoy, 34149, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis

Interventions

Tea Tree Oil; Ethanol

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Intervention Hierarchy (Ancestors)

Oils, Volatile; Oils; Lipids; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: April 1, 2025
• Study Start: February 12, 2024
• Primary Completion: June 17, 2024
• Study Completion: July 15, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

TU (1)