Gum stain removal using a ceramic drill
| ISRCTN | ISRCTN53999031 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53999031 |
- Submission date
- 03/12/2024
- Registration date
- 13/12/2024
- Last edited
- 13/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Gingival pigmentation is a cosmetic problem that patients complain about. This pigmentation occurs in patients with dark skin and is a physiological pigmentation. This study aims to test the pain and healing effect of a new method for removing gingival pigmentation, namely ceramic burs, as it is believed to be better than the surgical blade in terms of pain and healing.
Who can participate?
Adult patients aged between 18 and 45 years old who have moderate to severe gingival pigmentation
What does the study involve?
The removal of gingival pigmentation was undertaken using two techniques: ceramic bur and blade under local anesthesia. This study is expected to continue for one year from the beginning of patient recruitment.
What are the possible benefits and risks of participating?
Gingival pigmentation removal helps get rid of the dark color of the gums, which is a cosmetic problem, especially for patients with a gummy smile. This method does not pose any risks to the gums, bones, or general health of the patient.
Where is the study run from?
Damascus University, Syria
When is the study starting and how long is it expected to run for?
August 2021 to January 2023
Who is funding the study?
Damascus University, Syria
Who is the main contact?
Prof Ahmad Alnada, ahmad.alnada@damascusuniversity.edu.sy, dent.ahmad.1996@gmail.com
Contact information
Public, Scientific, Principal Investigator
Almazeh
Damascus
00258
Syria
| Phone | +963935481319 |
|---|---|
| dent.ahmad.1996@gmail.com |
Study information
| Study design | Randomized controlled clinical trial in the split-mouth design with a 1:1 allocation ratio |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| Scientific title | Assessing the gingival depigmentation of ceramic bur compared with surgical blade – randomized clinical trial |
| Study objectives | Healing is faster and pain is less when removing gum stains with ceramic burs. Ceramic burs are able to remove gum stains with similar efficiency to a blade. |
| Ethics approval(s) |
Approved 16/08/2021, Scientific Research and Postgraduate Studies Council (Damascus University, Baramkeh, Damascus, 00258, Syria; +963 1133923192; ap.srd@damascusuniversity.edu.sy), ref: DN-160822-179 |
| Health condition(s) or problem(s) studied | Gingival pigmentation |
| Intervention | This study examines physiological gingival depigmentation for cosmetic reasons using two methods. The control group uses the gold standard surgical blade to remove the superficial epithelium after local anesthesia. The study group uses ceramic burs mounted on a high-speed dental handpiece without irrigation to remove the superficial epithelium after local anesthesia. A single periodontist at the Periodontology Department, Faculty of Dentistry, Damascus University, performs all procedures. Healing is monitored for a month after a single application. Randomization is done using closed envelopes specifying the method and direction. Patients draw an envelope before the procedure to determine the method. Ten envelopes are prepared for the first patient, with methods distributed equally between the upper and lower jaws in a 1:1 ratio. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Gingival pigmentation is measured using the Dummet-Gupta Oral Pigmentation Index (DOPI) at baseline and 4 weeks 2. Pain is measured using the DOPI index at baseline, 24, 48, 72, 96, 120, 144 and 168h |
| Secondary outcome measures | Healing was measured using the Landry Wound Healing Index at 4 weeks |
| Overall study start date | 16/08/2021 |
| Completion date | 01/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Non-smoker patients 2. Moderate to severe gingival pigmentation, class 2 or 3, according to the Oral Pigmentation Index (DOPI) |
| Key exclusion criteria | 1. Systemic diseases 2. Hormonal disorders (thalassemia, Addison's disease) 3. Medication that may cause gingival pigmentation |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 01/06/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
00258
Syria
Sponsor information
University/education
Baramkeh
Damascus
002321
Syria
| Phone | +9631133923192 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | https://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 | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
04/12/2024: Study's existence confirmed by the Faculty of Dentistry, Damascus University.
