Clinical trial NCT05987722: Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery
Official title: Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Surgery
Keywords: Enoxolone
Wound healing
Plaque index.
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: wound healing index
timeFrame: after operation 1st, 2nd, 3rd, 4th, 8th, 12th week
Secondary outcomes:
measure: patient-reported pain score, painkillers
timeFrame: after operation 1week
measure: Periodontal pocket depth, Gingiva index, Plaque index
timeFrame: after operation 1st, 2nd, 3rd, 4th, 8th, 12th week
Other outcomes:
measure: adverse event
timeFrame: after operation 1st, 2nd, 3rd, 4th, 8th, 12th week
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital, Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University Hospital, Kaohsiung Medical University
name: Hsin-Tien Hsu, Professor
role: STUDY_DIRECTOR
References: