Investigating how well a turmeric extract gel helps in wound healing after the surgical removal of gingival pigmentation
| ISRCTN | ISRCTN69571802 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69571802 |
- Submission date
- 25/11/2024
- Registration date
- 29/11/2024
- Last edited
- 29/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
This study aimed to prepare turmeric extract gel with a concentration of 10% and compare it with a non-eugenol periodontal dressing (Coe-Pak) after the surgical removal of gingival pigmentation (black gums). This was carried out by evaluating wound healing, pain, the number of painkillers taken, bleeding on probing, plaque and the patient's esthetic and surgical satisfaction.
Who can participate?
Patients aged over 18 years with gingival pigmentation and good oral health
What does the study involve?
The study involves the removal of gingival pigmentation by a surgical scalpel on the upper jaw. The surgical procedure was performed in two phases, a week apart, and either the conventional dressing or the turmeric extract gel were applied.
What are the possible benefits and risks of participating?
The potential benefits of participating in this study are esthetic and the potential risks are almost non-existent.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
March 2023 to March 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Nadia Dibeh, dibehnadia@gmail.com
Contact information
Scientific, Principal Investigator
Almazzeh
Damascus
-
Syria
 ORCID ID |
0009-0002-3654-546X |
|---|---|
| Phone | +963 (0)45196074 |
| nadia3.dibeh@damascusuniversity.edu.sy |
Public
Almazzeh
Damascus
-
Syria
| Phone | +963 (0)933348834 |
|---|---|
| rowaidah.saymeh@damascusuniversity.edu.sy |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Efficiency evaluation of applying curcuma longa extract gel as a dressing after surgical gingival depigmentation |
| Study hypothesis | Turmeric extract gel is expected to reduce post-operative pain, the number of analgesics taken by the individuals, bleeding on probing, plaque accumulation, enhance the healing process of the wound and re-epithelialization, and improve patient's esthetic and surgical satisfaction, compared to coe-pak dressing. |
| Ethics approval(s) |
Approved 14/05/2023, Damascus University - Faculty of Dental Medicine (Almazah, Damascus, Nil known, Syria; +963 (0)113341864; manger@hcsr.gov.sy), ref: 223445 |
| Condition | Patients with bilateral class 3 or 4 of Hedin's classification of gingival pigmentation |
| Intervention | Gingival depigmentation was performed by a surgical scalpel in a split-mouth manner on the upper jaw of the research sample. The surgical procedure was performed in two phases, a week apart, and both the Coe-Pak and the turmeric extract gel 10% were applied to a randomly selected side using the coin toss method. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Pain measured using a Visual Analogue Scale (VAS) 0-100 and by recording the number of analgesics taken by the individuals at baseline, on the day of surgery and daily from post-surgical day 1 to 7 2. Wound healing assessment the Wound Healing Index (WHI) at 1, 2, 3, and 4 weeks post-surgery |
| Secondary outcome measures | The following secondary outcome measures are assessed at 1, 2, 3, and 4 weeks post-surgery: 1. Re-epithelialization index measured using toluidine blue and image J program 2. The patient's oral health measured using bleeding on probing index (BOP), plaque index (PI) 3. Patient satisfaction measured using a Visual Analogue Scale (VAS) 0-100 |
| Overall study start date | 15/03/2023 |
| Overall study end date | 08/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 12 patients (24 sites) |
| Total final enrolment | 16 |
| Participant inclusion criteria | 1. Good general health 2. There are no contraindications to periodontal surgery 3. Patients with bilateral, physiologic gingival pigmentation in the buccal maxillary gingiva, classified as class 3 or class 4 according to Hedin's classification 4. Good oral health: PI <1, BOP <10% 5. All patients are over 18 years old |
| Participant exclusion criteria | 1. Patients with systemic diseases or conditions associated with gingival pigmentation and could affect healing and coagulation 2. Drugs intake, especially those associated with gingival pigmentation 3. Periodontal diseases 4. Smokers and alcoholics 5. Pregnancy and lactation |
| Recruitment start date | 22/08/2023 |
| Recruitment end date | 30/01/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzah
Damascus
-
United Kingdom
Sponsor information
University/education
Albaramka
Damascus
-
Syria
| Phone | +963 (0)1133923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 10/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are/will be available upon request from Prof. Dr Rowaida Saymeh (rowaidah.saymeh@damascusuniversity.edu.sy). All of the patients' data will be available upon request. Consent was obtained from the participants. |
Editorial Notes
29/11/2024: Study's existence confirmed by the Damascus University - Faculty of Dental Medicine.
