Acute Mucous Inflammation, Inflammation of Mouth
Conditions
Keywords
Anthocyanin, Inflammation, Orthodontic treatment
Brief summary
The purpose of this study is to compare the oral inflammatory reduction effect caused from orthodontic treatment of anthocyanin and placebo mouthrinse.
Detailed description
Multiple inflammatory lesions caused from orthodontic treatments are commonly found in these patients and the irritations from the insertion of the orthodontic wire are hard to apply the topical cream or gel. Standard treatment to prevent oral mucosal irritation caused from orthodontic brackets and wires is an orthodontic wax to cover the appliances. However, the covering wax is just a prophylactic measure to protect the mucosal irritation. Thus, the patients still need a specific treatment for their oral inflammatory condition. Developing a product that can treat entire inflammatory areas in oral cavity, promote oral hygiene, and anti-fungal would be beneficial and useful for the orthodontic treatment. Anthocyanins, one of a natural compound from red, blue, purple vegetables, fruits, and flowers, have many beneficial effects including anti-inflammation and the most important effect superior to steroid usage is anti-candidiasis. Interesting in anthocyanins as the natural treatment, has drawn attention due to the benefits in oral inflammation. Previous study on the effect of a topical anthocyanin gel demonstrated positive effect of topical anthocyanins gel against oral inflammation in human subjects at 6 weeks. Unfortunately, anthocyanin is not stable and easily to be degraded. Therefore, stabilized anthocyanin oral formulation needs to be developed and the formulation needs to provide stable and active anthocyanins in suitable oral formula. This study aims to prepare and investigate effects of anthocyanin complex in order to formulate the mouthrinse for anti-inflammation caused by orthodontic treatment. Thus, to prepare and investigate the effects of anthocyanin activities after forming complexation in order to formulate the mouthrinse would be evaluated. In addition, the examination of anti-oral inflammation caused by orthodontic treatment by anthocyanin complex in clinical trial will be conducted.
Interventions
DRUGAnthocyanin
Anti-inflammation gel
DRUGPlacebo
Blank gel
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Male and/or females between the ages of 18 and 35 with oral inflammation, investigated by a dentist, caused by orthodontic devices. * The inflammatory lesions are occurred at labial and/or buccal mucosa. * Be able to communicate well with the investigator and to comply with the requirements of the entire study. * Not participate in other project(s). * Be willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions and examination schedule.
Exclusion criteria
* \- Have the persistent inflammatory lesions and/or ulcers that cannot be healed more than 2 weeks or the inflammation that may lead to be oral cancer. * Have severe oral inflammation or the inflammation occur from ongoing head and neck chemotherapy or serious oral inflammatory such as periodontitis and oral lichen planus. * Taking steroid or applying topical steroid within or 7 days before participated in this study. * Have a history of allergy or hypersensitivity to any red, blue, or purple color fruits and vegetables such as berry groups. * Patients with auto-immune diseases or diseases that related to wound healing process such as diabetes. * Patients that cannot meet the follow up or drop out of the experiments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Size (mm^2) Reduction | Days 0 and 7 after treatment | Comparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment |
Secondary
| Measure | Time frame |
|---|---|
| VAS Scores Range From 0 (no Pain) to 10 (Severe Pain) | Days 0 and 7 after treatment |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebol Blank gel
Anthocyanin: Anti-inflammation gel | 36 |
| Anthocynin Anthocyanin gel
Placebo: Blank gel | 34 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Anthocynin | Total | Placebol |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 70 Participants | 36 Participants |
| Age, Continuous | 22.4 years STANDARD_DEVIATION 1.6 | 22.3 years STANDARD_DEVIATION 1.6 | 22.1 years STANDARD_DEVIATION 1.5 |
| Region of Enrollment Thailand | 34 participants | 70 participants | 36 participants |
| Sex: Female, Male Female | 25 Participants | 54 Participants | 29 Participants |
| Sex: Female, Male Male | 9 Participants | 16 Participants | 7 Participants |
| VAS scores range from 0 (no pain) to 10 (severe pain) | 3.6 scores on a scale STANDARD_DEVIATION 1.7 | 3.6 scores on a scale STANDARD_DEVIATION 1.7 | 3.6 scores on a scale STANDARD_DEVIATION 1.8 |
| wound area | 26.5 mm^2 STANDARD_DEVIATION 32.2 | 29.08 mm^2 STANDARD_DEVIATION 35.01 | 33.3 mm^2 STANDARD_DEVIATION 37.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 34 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 |
Outcome results
Primary
Wound Size (mm^2) Reduction
Comparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment
Time frame: Days 0 and 7 after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebol | Wound Size (mm^2) Reduction | 11.26 mm^2 | Standard Deviation 14.22 |
| Anthocynin | Wound Size (mm^2) Reduction | 8.92 mm^2 | Standard Deviation 14.86 |
Secondary
VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)
Time frame: Days 0 and 7 after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebol | VAS Scores Range From 0 (no Pain) to 10 (Severe Pain) | 1.53 units on a scale | Standard Deviation 1.67 |
| Anthocynin | VAS Scores Range From 0 (no Pain) to 10 (Severe Pain) | 0.96 units on a scale | Standard Deviation 0.68 |