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

Altinbas University

Status and phase: Completed; Phase 4

Conditions: Periodontal Diseases

Treatments: Drug: Tea tree oil; Drug: Placebo; Drug: Thyme oil hydrosol; Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT

Study type: Interventional

Funder types: Other

Identifiers

NCT06904742

2023/213

Details and patient eligibility

About

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).

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 4 patient groups, including a placebo group

Tea Tree Oil Mouthwash Group

Active Comparator group

Description:

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.

Treatment:

Drug: Tea tree oil

non-alcohol EO mouthwash group

Active Comparator group

Description:

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)

Treatment:

Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT

thyme-containing hydrosol group

Active Comparator group

Description:

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).

Treatment:

Drug: Thyme oil hydrosol

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo