Clinical trial NCT06904742: Clinical and Microbiological Evaluation Of The Efficacy Of Herbal Mouthwashes in Gingivitis
Official title: Clinical and Microbiological Evaluation Of The Efficacy Of Herbal Mouthwashes in Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Diseases
Keywords: gingivitis
essential oil
tea tree oil
thyme
qPCR
Lead sponsor: Altinbas University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in PI
timeFrame: 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
measure: Reduction in GI
timeFrame: 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
measure: Reduction in Bleeding on Probing
timeFrame: 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:
measure: Reduction in PPD
timeFrame: 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
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Altinbas University
state: Bakirkoy
Study officials:
References: