Evaluating the effects of two different lip lift techniques on the relapse and nasal facial proportions
| ISRCTN | ISRCTN17452386 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17452386 |
| ClinicalTrials.gov number | Nil Known |
- Submission date
- 19/03/2025
- Registration date
- 21/03/2025
- Last edited
- 21/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to compare two different techniques for lip lift surgery to see how they affect the appearance of the upper lip and nose. The goal is to improve the look of the upper lip by making it shorter and enhancing overall facial harmony.
Who can participate?
Adults aged 18 or older who have a long upper lip and have not had any previous lip-enhancing procedures, like fillers, can participate. Participants should be in good health and not have any conditions that affect wound healing.
What does the study involve?
Participants will undergo one of two types of lip lift surgery at Damascus University. Before-and-after photos will be taken before the surgery and six months after. Measurements will be made to analyze changes in lip length, nasal shape, and overall aesthetics. Participants will also complete surveys to share their satisfaction with the results.
What are the possible benefits and risks of participating?
Benefits:
Improved lip and facial aesthetics.
Evaluation of surgical outcomes.
Risks:
Swelling, bruising, scarring, and minor discomfort, which are common with any surgery.
Temporary numbness or tightness in the upper lip for some patients.
Where is the study run from?
The study is conducted at Damascus University, Oral and Maxillofacial Surgery Department (Syria)
When is the study starting and how long is it expected to run for?
March 2022 to April 2025.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Sleiman Zayoud, dr.sleiman.zayoud@gmail.com
Contact information
Public, Scientific, Principal Investigator
Damascus University
Damascus
-
Syria
 ORCID ID |
0009-0004-2433-0052 |
|---|---|
| Phone | +963 992888999 |
| sleiman.zayoud@gmail.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Quality of life, Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Comparison between the modified bullhorn lip lift and the endonasal technique on the nasal facial proportions and relapse: a randomized clinical trial (RCT) |
| Study objectives | 1. There is no significant difference in the impact of Endonasal Lip Lift and Modified Upper Lip Lift on the nasal shape postoperatively 2. There is no significant difference in the skin relapse between the two mentioned techniques |
| Ethics approval(s) |
Approved 27/04/2022, Biomedical Research Ethics Committee at Damascus University (Damascus University, Damascus, -, Syria; +963 1133923476; sdg@damascusuniversity.edu.sy), ref: DN-210125-390 |
| Health condition(s) or problem(s) studied | Enhancing the cosmetic proportions of the upper lip skin, vermillion, and teeth show during rest by reducing the upper lip skin length. |
| Intervention | Performing upper lip lift surgery using one of the two techniques: Modified Upper Lip Lift Technique described by Talei, et al, and Endonasal Lip Lift Technique Described by Raphael, et al. The study includes: Preoperative assessment (clinical examination, photography, and measurements. Postoperative follow-up at 6 months (T2) to evaluate the following: Changes in lip and nasal measurements, relapse, patient satisfaction using PSQ questionnaire, and scar assessment using POSAS method. The randomization process was conducted using Randomizer.org. Patients assigned number one were placed in the modified lip lift technique group, while those assigned number two underwent the endonasal lip lift procedure. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Skin Relapse in millimeters measured using a caliper at preoperative (T0), 6 months post surgery (T1) |
| Secondary outcome measures | Preoperative (T0), 6 months post surgery (T1): 1. Upper lip relationship with the E-Line 2. Nasal tip changes according to Powel 3. Nasal width (mm) 4. Nostrils width (mm) 5. Nasolabial angle 6. Upper lip projection 7. Patient satisfaction using PSQ questionnaire 8. Scar assessment using POSAS method Direct measurements are taken using a caliper, while photographic measurements are analyzed using ImageJ software |
| Overall study start date | 27/03/2022 |
| Completion date | 03/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | 12 patients, 6 in each group |
| Total final enrolment | 12 |
| Key inclusion criteria | 1. Patients aged 18 years or older. 2. No prior lip augmentation procedures. 3. Nasolabial height to vermilion height ration grater than 3, classiftying them as lip type 2 or 3 according to Raphael and Harris. 4. No congenital syndromes or systemic diseases that could affect wound healing. 5. No bleeding disorders or anticoagulants. 6. No planned facial surgical interventions during the study period. 7. Commitment to regular follow ups. |
| Key exclusion criteria | 1. Chronic diseases and infections. 2. Bleeding disorders or on anticoagulants. 3. Undergoing immunosuppressive therapy. 4. Patients undergoing orthodontic treatment. 5. Severe gummy smile. 6. History of lip augmentation procedure. 7. Patients scheduled for orthognathic surgery. 8. Lip type 1 according to Raphael and Harris (2014). 9. Pregnant, or breastfeeding women. |
| Date of first enrolment | 16/05/2022 |
| Date of final enrolment | 03/10/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Sponsor information
University/education
Mazzeh
Damascus
-
Syria
| Phone | +963 947833522 |
|---|---|
| sdg@damascusuniversity.edu.sy | |
| Website | https://www.damascusuniversity.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 30/05/2025 |
|---|---|
| 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 peer-reviewed 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
21/03/2025: Trial's existence confirmed by Damascus University.
