New surgical technique for facial dimple creation
| ISRCTN | ISRCTN96988513 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96988513 |
| Secondary identifying numbers | 0000 |
- Submission date
- 08/10/2024
- Registration date
- 09/10/2024
- Last edited
- 09/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Surgical creation of facial dimples (dimpleplasty) was first introduced by Boo-Chai in 1962. Despite advancements in surgical approaches made in recent years, there remains a need for a reliable, minimally invasive method that ensures consistent results and high patient satisfaction. This study aims to evaluate a newly proposed surgical technique for facial dimpleplasty, focusing on patient satisfaction, and early recovery symptoms and complications.
Who can participate?
Patients aged between 18 and 30 years who requested dimpleplasty
What does the study involve?
Patients were randomly assigned to either the control group, who received the original dimpleplasty technique, or the test group, who underwent a new surgical technique. Patient-reported outcomes, such as the patient’s satisfaction with their decision, outcome and face appearance, and complications were assessed.
What are the possible benefits and risks of participating?
This study will determine the effectiveness of a newly developed surgical procedure for dimpleplasty compared to the conventional method. There is a risk of not achieving optimal results in some cases but the study team can manage these cases with other methods.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
May 2022 to May 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Omar Hamdan, omarhamdancedr@gmail.com
Contact information
Public, Scientific, Principal Investigator
Damascus
Damascus
00000
Syria
 ORCID ID |
0009-0000-6108-9625 |
|---|---|
| Phone | +963 (0)991184253 |
| omarhamdancedr@gmail.com |
Study information
| Study design | Comparative interventional randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Quality of life, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A new proposed surgical technique for dimpleplasty |
| Study objectives | Does the newly proposed surgical technique for dimpleplasty perform better than the conventional technique in terms of patient satisfaction, early recovery symptoms, and complications. |
| Ethics approval(s) |
Approved 10/06/2022, Damascus University ethics committee (Damascus, Damascus, 0000, Syria; +963 (0)992964458; manager@hcsr.gov.sy), ref: 22918 |
| Health condition(s) or problem(s) studied | Artificial facial dimpleplasty |
| Intervention | The first group received dimpleplasty following the technique described by Bao et al. (2007) (control group), while the second group underwent dimpleplasty using a new surgical technique proposed by the authors of this study (test group). Randomization method: sealed envelope method Control group: All surgical procedures were performed under local anesthesia. The ideal location of the facial dimple was determined. The location of the dimple placement was marked on the cheek skin. The buccal mucosa was incised using a no.15 blade, with the incision measuring 2 to 3 mm in length and positioned below the papilla of the Stensen’s duct. A syringe needle is then punctured through the cheek from the marked skin and pulled through the buccal mucosa incision. A 3-0 monofilament nylon suture is threaded into the pinhole of the syringe needle and drawn through using a vacuum extractor. Once the suture is pulled through, the needle is gradually withdrawn to the dermis. The needle’s direction is then adjusted, puncturing through the dermis and muscle, and pulled through the buccal mucosa incision again. The suture was drawn through the pinhole of the syringe needle, which was then removed from the skin. This process sutures the active facial muscles and dermis together. The knot is tied, forming the dimple. Test group: All surgical procedures were performed under local anesthesia. The ideal location of the facial dimple was determined. The location of the dimple placement was marked on the cheek skin. A syringe needle was punctured through the cheek from the marked skin and pulled through the buccal mucosa incision. The buccal mucosa was incised using a no.15 blade, with the incision measuring 4 to 6 mm in length. Dissection of the mucosa was performed to reveal the underlying buccinator muscle. A rectangular portion of the muscle (6 × 4 mm) was excised using fine tissue scissors. The remaining muscle parts and the dermis were then connected using an absorbable 3-0 Vicryl thread. A knot was made between the muscle and the dermis at the upper part of the incision, and another knot was made at the lower part of the incision. The buccal mucosa was closed with a 5-0 monofilament nylon suture. Follow-up duration: 2 weeks |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Patient’s satisfaction with decision assessed using the FACE-Q instrument 1 week after the procedure 2. Patient’s satisfaction with outcome assessed using the FACE-Q instrument 4 weeks after the procedure 3. Patient’s satisfaction with overall face appearance assessed using the FACE-Q instrument at baseline and 2 weeks after |
| Secondary outcome measures | Post-operative complications evaluated using a four-point scale questionnaire 1 week after the procedure |
| Overall study start date | 09/05/2022 |
| Completion date | 19/05/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Female |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Aged between 18 and 30 years 2. Capable of understanding the study procedures and committed to follow-up 3. Maintaining good oral hygiene |
| Key exclusion criteria | 1. Presence of any facial deformities 2. Previous dimpleplasty procedures 3. Suffering from systemic diseases 4. Undergoing radiation therapy in the head and neck region within the last 6 months 5. Smoking |
| Date of first enrolment | 22/11/2022 |
| Date of final enrolment | 22/03/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
0000
Syria
Sponsor information
University/education
Damascus
Damascus
0000
Syria
| Phone | +963 (0)113341864 |
|---|---|
| manager@hcsr.gov.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 | 19/05/2025 |
|---|---|
| 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 analysed during the current study will be available on request from Dr Omar Hamdan (omarhamdancedr@gmail.com) and in the publication related to it after the end of the research. Type of data that will be shared: demographic information (age, gender), location of the dimpleplasty, clinical measurements, and the photos of the clinical procedure. |
Editorial Notes
09/10/2024: Study's existence confirmed by Damascus University.
