Periodontal Surgery
Conditions
Keywords
Enoxolone, Wound healing, Plaque index.
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.
Interventions
OTHEREnoxolone
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.
OTHERSensodyne
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.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The experimental group and the control group were randomly assigned by lottery drawing.
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound healing index | 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
| Measure | Time frame | Description |
|---|---|---|
| patient-reported pain score, painkillers | 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. |
| Periodontal pocket depth, Gingiva index, Plaque index | 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
| Measure | Time frame | Description |
|---|---|---|
| adverse event | after operation 1st, 2nd, 3rd, 4th, 8th, 12th week | allergy |
Countries
Taiwan
Outcome results
None listed