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Completed

NCT Number: NCT05987722

Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery

Abstract Aim:The Enoxolone (18β-glycyrrhetinic acid; BGA) is a bioactive compound in licorice that exhibits potential anti-ulcer, anti-inflammatory, and anti-microbial activities, relieve oral ulcers, pain, improve gingivitis and dental plaque from past relevant experimental studies,but few clinical trials have evaluated its clinical effectiveness. Therefore, the purpose of this study is to evaluate the effectiveness of Enoxolone on oral conditions of patients with periodontal surgery. Methods:This study is a randomized controlled trial. Patients with severe chronic periodontitis who needed to accept periodontal surgery were randomly assigned to two groups, the experimental group was Enoxolone toothpaste, and the control group for Sensodyne toothpaste. After the operation, toothpaste was used three times a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported pain score, painkillers, wound healing index (complete epithelization and color matching score), periodontal pocket depth, gingiva index, plaque index and were recorded before operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. Data set performs repeated-measures for the change in mean differences by using the two-tailed independent t tests and generalized linear model.

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Key information

Conditions

Periodontal Surgery

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Hospital, Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

About this study

Enoxolone is a toothpaste containing 18β-glycyrrhetinic acid (BGA). In this study, the experimental group used Enoxolone toothpaste, and the control group did not contain BGA toothpaste (Sensodyne), which is used for oral cleaning of patients after periodontal disease surgery. The absorption rate is very low, and it will not cause any interaction with western medicine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those who are over 20 years old.
  • Those whose health or systemic diseases are well controlled.
  • Those with severe chronic periodontitis who need to perform periodontal surgery after being diagnosed by a doctor.
  • Subjects who are willing to accept this study.

Exclusion criteria

  • Allergy to licorice.
  • Pregnancy or breastfeeding.
  • Periodontal surgery completed at the same site within 6 months.
  • Severe bone loss in the apical tissue of the surgical site (including poor prognosis).
  • Clinical signs of infection, including fistula, suppuration, fever, severe pain and site swelling.
  • Platelets less than 50,000.

Treatment and study plan

Enoxolone

Other

The experimental group returned home after the operation and used glycyrrhetinic acid toothpaste three times a day for oral cleaning.After the operation, toothpaste was used three times a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported pain score, painkillers, wound healing index (complete epithelization and color matching score), periodontal pocket depth, gingiva index, plaque index and were recorded before operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. The control group used ordinary toothpaste for oral cleaning, and the rest of the research time, measurement time and measurement results were the same as the experimental group. During the study period, we will continue to monitor whether there is any adverse reaction, and if any adverse reaction occurs, the trial will be stopped.

Sensodyne

Other

The Active Comparator group returned home after the operation and used glycyrrhetinic acid -free toothpaste(Sensodyne) three times a day for oral cleaning. After the operation, toothpaste was used three times a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported pain score, painkillers, wound healing index (complete epithelization and color matching score), periodontal pocket depth, gingiva index, plaque index and were recorded before operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. The control group used ordinary toothpaste for oral cleaning, and the rest of the research time, measurement time and measurement results were the same as the experimental group. During the study period, we will continue to monitor whether there is any adverse reaction, and if any adverse reaction occurs, the trial will be stopped.

Primary outcomes

  1. wound healing index

    Time frame: after operation 1st, 2nd, 3rd, 4th, 8th, 12th week

    epithelization and color matching score: A score of 0-10, higher indicates better wound healing.

Secondary outcomes

  1. patient-reported pain score, painkillers

    Time frame: after operation 1week

    the patient-reported pain score(VAS): 0-10 points, the higher the worse. painkillers: 0-15 pills, the more the remaining number of drugs, the better.

  2. Periodontal pocket depth, Gingiva index, Plaque index

    Time frame: after operation 1st, 2nd, 3rd, 4th, 8th, 12th week

    Periodontal pocket depth: 0-15 mm, the higher it means bad. Gingiva index: 0-3 points, higher means bad. Plaque index: 0-3 points, higher means bad.

Other outcomes

  1. adverse event

    Time frame: after operation 1st, 2nd, 3rd, 4th, 8th, 12th week

    allergy

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Acronym: Enoxolone

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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