Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery (Enoxolone)

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Surgery
• Intervention / Treatment: Other: Enoxolone; Other: Sensodyne

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Hospital, Kaohsiung Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enoxolone; The experimental group (N=15) returned home after the operation and used BGA toothpaste (Enoxolone) three times a day for oral cleaning for 12 weeks.	Other: Enoxolone; 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.
Active Comparator: Sensodyne; The control group (N=12) used BGA-free toothpaste (Sensodyne) for oral cleaning for 12 weeks.	Other: Sensodyne; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing index	epithelization and color matching score: A score of 0-10, higher indicates better wound healing.	after operation 1st, 2nd, 3rd, 4th, 8th, 12th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient-reported pain score, painkillers	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.	after operation 1week
Periodontal pocket depth, Gingiva index, Plaque index	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.	after operation 1st, 2nd, 3rd, 4th, 8th, 12th week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse event	allergy	after operation 1st, 2nd, 3rd, 4th, 8th, 12th week

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Director: Hsin-Tien Hsu, Professor, Kaohsiung Medical University Hospital, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): December 8, 2022

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Wound healing; Enoxolone; Plaque index.
• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Glycyrrhetinic Acid
• Other Study ID Numbers: KMUHIRB-F(II)-20200136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No