Curly kale relieves inflammation after tooth extraction
| ISRCTN | ISRCTN48573608 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48573608 |
| EudraCT/CTIS number | Ni known |
| Secondary identifying numbers | 65/2565 |
- Submission date
- 28/02/2024
- Registration date
- 18/03/2024
- Last edited
- 18/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Curly kale is an edible vegetable that has biological and nutraceutical properties. Interestingly, among chemical compositions, anthocyanins are active ingredients which present analgesic and anti-inflammatory activities. This study aims to compare the effectiveness of a water extract of kale leaves with ibuprofen in reducing pain and inflammation in patients after lower third molar extraction.
Who can participate?
Patients aged 18-25 years old with impacted left and right lower mandibular third molars
What does the study involve?
Each participant will be asked to take the encapsulated kale extract or ibuprofen and vice versa for 7 days. Pain and inflammation indicators will be assessed daily for 7 days after each molar extraction.
What are the possible benefits and risks of participating?
Participants may benefit from consuming an anthocyanin-rich kale supplement as it will relieve pain, inhibit inflammation, and avoid adverse effects of Non-steroidal anti-inflammatory drugs (NSAIDs) in patients after lower third molar extraction and consumption of ibuprofen. Participants may be at risk if they are allergic to plant-derived products.
Where is the study run from?
The study protocol has been approved by the ethical committee of the Faculty of Dentistry, Chiang Mai University, and the trial will be conducted at the Oral and Maxillofacial Surgery Clinic, Faculty of Dentistry, Chiang Mai University
When is the study starting and how long is it expected to run for?
December 2022 to March 2023
Who is funding the study?
This work will be performed under the Residency Training Program in Oral and Maxillofacial Surgery, Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand, consumable chemicals and reagents was partially supported by the Royal Project Foundation, Chiang Mai.
Who is the main contact?
Dr. Vuttinun Chatupos, D.D.S., vuttinunch@yahoo.co.th, vuttinun.ch@cmu.ac.th
Contact information
Public, Scientific, Principal Investigator
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chiang Mai University
Chiang Mai
50200
Thailand
| Phone | +66 53944455 |
|---|---|
| vuttinun.ch@cmu.ac.th |
Public, Scientific, Principal Investigator
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chiang Mai University
Chiang Mai
50200
Thailand
| Phone | +66 53944455 |
|---|---|
| vuttinunch@yahoo.co.th |
Study information
| Study design | Split-mouth randomized single-center clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Dental clinic |
| Study type | Efficacy |
| Participant information sheet | 45108 PIS (English version).pdf |
| Scientific title | A randomized controlled study comparing anti-inflammatory effect between ibuprofen and curly kale (Brassica oleracea var. sabellica) extract in patients after extraction of impacted lower mandibular third molars |
| Study hypothesis | Curly kale leaves which are abundant with flavonoids (e.g. anthocyanins) exert strong anti-inflammatory and wound healing effects on the tooth extraction wound. |
| Ethics approval(s) |
Approved 16/12/2022, Human Experimentation Committee, Faculty of Dentistry (Chiang Mai University, Chiang Mai, 50200, Thailand; +66 5394451; anak.ia@cmu.ac.th), ref: 12/12/2565 |
| Condition | Patients after surgical removal of impacted mandibular third molar |
| Intervention | In this split-mouth randomized single-center clinical trial, patients (n = 20, aged 18-25 years) following surgical removal of two impacted mandibular third molar (1 month apart) will be asked to take ibuprofen and encapsulated kale extract for 7 days. Patients are randomised using the Block randomization method For the interventional study, the same surgeon performed all the surgery at our institution (S.N., T.S., A.K.). Volunteers received anesthetic blockade of the inferior alveolar nerve and lingual nerve block of the surgical site with 1.8 mL of the anesthetic solution (Septanest® SP, Septodont, France) containing 4% articaine and 1:100,000-dilution epinephrine. Three minutes after this injection, every volunteer received an additional injection of 0.9 mL of the same anesthetic solution into the buccal mucosa of the surgical area to guarantee hemostasis and complete anesthesia of the region. Immediately after this injection, the lower third molar surgery commenced via a standard protocol. For postoperative pain management, participants were informed to take the kale extract capsule (500 mg anthocyanin equivalent) and an ibuprofen tablet (400 mg size, Probufen-400, Advanced Pharmaceutical Manufacturing Company Limited, Bangkok, Thailand) after the extraction of impacted mandibular third molar or vice versa every 6 hours for 7 days. In addition, 500 mg amoxicillin (SANOMOX - G 500, SEVEN STARS PHARMA, Thailand) was prescribed 4 times daily for 5 days. If needed or VAS > 5, analgesic medication by 500 mg acetaminophen (Tylenol, OLIC Limited Company, Thailand) was available for all volunteers throughout the study. The subjects were instructed to assess their pain level using the VAS scoring tool and collect their saliva for analysis of -amylase activity, MMP9 and TGF-2 concentrations. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The following primary outcome measures were assessed in saliva specimens collected before tooth extraction and on days 3 and 7 after tooth extraction: 1. Alpha-amylase activity measured using a colorimetric method 2. MMP9 concentrations measured using sandwich-type ELISA kits 3. TGF-1 concentrations measured using sandwich-type ELISA kits |
| Secondary outcome measures | Pain was measured using a visual analogue scale (VAS) every day for 7 days |
| Overall study start date | 01/11/2022 |
| Overall study end date | 31/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Participant inclusion criteria | 1. Healthy according to the American Society of Anesthesiologists (ASA) criteria: Level I and II 2. Male and female 3. 18-25 years old 4. Had left and right lower mandibular third molars impacted |
| Participant exclusion criteria | 1. History of ibuprofen sensitivity 2. Painful of mandibular third molar or maxillofacial area before operation 3. Taken an analgesic drug for one week before surgical removal of impacted mandibular third molar 4. Psychiatric 5. Non-compliance on recording pain and symptoms after operation 6. Unable to revisit for the next follow-up |
| Recruitment start date | 04/01/2023 |
| Recruitment end date | 30/03/2023 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Chiang Mai
50200
Thailand
Sponsor information
University/education
Office of Human Experimentation Committee, Faculty of Dentistry, Chiang Mai University, Suthep Street, Tabmol Suthep, Amphur Meung
Chiang Mai
50200
Thailand
| Phone | +66 5394451 |
|---|---|
| anak.ia@cmu.ac.th | |
| Website | https://www.cmu.ac.th/ |
"ROR" |
https://ror.org/05m2fqn25 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Thailand
Results and Publications
| Intention to publish date | 05/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Dr. Vuttinun Chatupos, D.D.S., vuttinunch@yahoo.co.th |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | English | 18/03/2024 | No | Yes | |
| Participant information sheet | Thai | 18/03/2024 | No | Yes | |
| Protocol file | 18/03/2024 | No | No |
Additional files
Editorial Notes
18/03/2024: Trial's existence confirmed by Human Experimentation Committee, Faculty of Dentistry.
