NCT05987722|Completed
Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery
Enoxolone
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Enoxolone
Sponsor study identifier
interventional
27
1 country
1
Study Start
July 30, 2021
Actual (reported)Primary Completion
June 1, 2022
Actual (reported)Study Completion
December 8, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 8, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 30, 2021
Actual (reported)June 1, 2022
Actual (reported)December 8, 2022
Actual (reported)July 21, 2023
Actual (reported)August 14, 2023
Actual (reported)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
patient-reported pain score, painkillers
after operation 1week
Periodontal pocket depth, Gingiva index, Plaque index
after operation 1st, 2nd, 3rd, 4th, 8th, 12th week
adverse event
after operation 1st, 2nd, 3rd, 4th, 8th, 12th week
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 for 12 weeks.
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.
Kaohsiung Medical University Hospital, Kaohsiung Medical University
Kaohsiung City, 807, Taiwan
Hsin-Tien Hsu, Professor
Kaohsiung Medical University Hospital, Kaohsiung Medical University
27 participants (actual enrollment reported by the registry).
First Submitted
July 21, 2023
Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment
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.
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First Posted
August 14, 2023
Study Start
July 30, 2021
Actual (reported)Primary Completion
June 1, 2022
Actual (reported)Study Completion
December 8, 2022
Actual (reported)Last Updated
August 14, 2023
Record last verified: 2023-04
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