Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery

NCT05987722 | Completed

• 1 other identifier: KMUHIRB-F(II)-20200136
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Surgery

Keywords

Enoxolone; Wound healing; Plaque index.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• patient-reported pain score, painkillers

  after operation 1week

• Periodontal pocket depth, Gingiva index, Plaque index

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

Other Outcomes (1)

• adverse event

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

Study Arms (2)

Enoxolone

EXPERIMENTAL

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

Sensodyne

ACTIVE COMPARATOR

The control group (N=12) used BGA-free toothpaste (Sensodyne) for oral cleaning for 12 weeks.

Other: Sensodyne

Interventions

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.

Enoxolone

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.

Sensodyne

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital, Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Interventions

Glycyrrhetinic Acid; Sensodyne

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Hsin-Tien Hsu, Professor

  Kaohsiung Medical University Hospital, Kaohsiung Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The experimental group and the control group were randomly assigned by lottery drawing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient underwent routine periodontal surgery procedures: (1) On the first day of surgery, the researchers confirmed the correctness of the patient's oral hygiene instructions before surgery; (2) All periodontal surgery was performed by the same dentist. After periodontal surgery was sutured, antibiotics (Amoxicillin 500 mg, every 8 h, for 7 days) and painkillers (Acetaminophen 250 mg, every 6 h as long as it is painful) were provided. 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. The control group (N=12) used BGA-free toothpaste (Sensodyne) for oral cleaning, and the rest of the research time, measurement time and measurement results were the same as those of the experimental group.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 14, 2023
• Study Start: July 30, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 8, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)