A clinical trial to assess the clinical efficacy of functional toothpastes for improvement of periodontitis with different active ingredients

A Randomized controlled clinical trial to assess the clinical efficacy of functional toothpastes for improvement of periodontitis with different active ingredients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008981

Enrollment

Registered

2023-11-24

Start date

2023-11-30

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Others(quasi-drug) : For a duration of 12 weeks, employ a single variety of over-the-counter toothpaste along with two different quasi-drug toothpaste options, each containing 10mg/g of Enoxolon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The selection criteria are as follow: (1) Individuals aged 19 or older, both male and female with permanent teeth. (2) Those who meet the criteria 1 or 2 of the American Society of Anesthesiologists (ASA) (3) Those who have consented to participate in the clinical trial and voluntarily consented in writing. (4) An individual who, through clinical examination, has at least two permanent teeth with an average probing pocket depth (PPD) of 4 mm or greater. (5) An individual with a minimum of 20 permanent teeth.

Exclusion criteria

Exclusion criteria: (1) An individual with a prior history of hypersensitivity to quasi-drugs used in clinical trials or drugs from the same family. (2) Individuals with conditions such as diabetes, HIV, heart disease, osteoporosis, and lactose intolerance. (3) An individual who has undergone periodontal and antibiotic treatments in the past month. (4) An individual with a history of using medications that might affect treatment outcomes, including painkillers like NSAIDs, antibiotics, or steroids, within the past week. (5) Women who are currently pregnant or breastfeeding. (6) A person who is a tobacco smoker. (7) An individual who faces challenges in maintaining their oral hygiene independently. (8) Those who encounter difficulty in comprehending and following the instructions provided in clinical studies. (9) An individual deemed ineligible for participation in clinical trials by other evaluators.

Design outcomes

Secondary

Measure	Time frame
Clinical attachment level;Gingival index;Bleeding on probing;Subgingival bacteria count	—

Primary

Measure	Time frame
Probing pocket depth	—

Countries

Korea, Republic of

Contacts

Public ContactHyun-Jung Kim

Kyung Hee University Dental Hospital

kimhyunjung@khu.ac.kr+82-2-958-9330

Outcome results