Traditional versus limited delamination entry points: a study assessing the enhancement of the jowl and the labiomandibular fold in primary rhytidectomy
| ISRCTN | ISRCTN31166644 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31166644 |
| Sponsor | Ain Shams University Faculty of Medicine |
| Funder | Investigator initiated and funded |
- Submission date
- 28/06/2026
- Registration date
- 01/07/2026
- Last edited
- 30/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This research compared two different surgical techniques for face and neck lifts to see which approach provides better and longer-lasting results for the lower face and jawline.
Who can participate?
Adult patients (ages 45–70) seeking a primary face and neck lift for signs of aging, such as sagging jowls and prominent mouth lines.
What does the study involve?
Patients were randomly assigned to one of two groups using a computer-generated sequence.
Group A (Traditional Entry Point): Surgeons performed a wider area of skin separation (delamination) before reaching the deeper tissue layers.
Group B (Preservation Entry Point): Surgeons used a newer "limited delamination" technique, which involves keeping more of the skin connected to the underlying tissue layers.
Measurements: Visual Assessment: Independent surgeons, who did not know which technique was used for each patient, graded the patients' jowl and mouth line improvements using standardized photographic scales.
Patient Satisfaction: Patients completed standardized questionnaires (FACE-Q) to rate their satisfaction with their appearance and the surgical outcome.
Tissue Science (Biomechanical Testing): During the surgery, small samples of the tissue layer, usually removed during a facelift (the SMAS), were tested in a laboratory to measure how much they stretch, relax, and elongate under tension.
Follow-up: Surgeons and patients evaluated the results at 1 month and again at 12 months after the surgery to check for long-term stability.
What are the possible benefits and risks of participating?
Participants may benefit from facial rejuvenation and improved aesthetic outcomes. Risks are those associated with elective rhytidectomy, including potential hematoma, seroma, and temporary neuropraxia, all of which are managed with standard conservative care.
Where is the study run from?
Ain Shams University Faculty of Medicine, Egypt.
When is the study starting and how long is it expected to run for?
September 2024 to June 2026.
Who is funding the study?
Investigator initiated and funded.
Who is the main contact?
Dr Mohamed Afifi, mohamednagyb0100066@med.asu.edu.eg
Contact information
Principal investigator, Public, Scientific
Ain Shams Specialized Hospital
Cairo
11588
Egypt
| Phone | +20 01003856322 |
|---|---|
| mohamednagyb0100066@med.asu.edu.eg |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Computer based program |
| Purpose | Treatment |
| Participant information sheet | 49807_PIS2 [Egyptian].jpeg |
| Scientific title | TEP vs. PEP in primary rhytidectomy |
| Study objectives | To compare aesthetic efficacy: The primary objective was to perform the first prospective, randomized comparison of the aesthetic efficacy of the Traditional Entry Point (TEP) versus the Preservation Entry Point (PEP) rhytidectomy approaches. To assess long-term longevity: The study aimed to determine if either approach offers verifiable improvements in the longevity of aesthetic results against gravitational descent over a 12-month follow-up interval. To quantify biomechanical properties: An explicit objective was to bridge the current lack of quantitative data by providing an ex-vivo biomechanical analysis to compare the tensiometric and viscoelastic properties of the SMAS tissue used in each surgical approach. To evaluate lower facial correction: The study sought to specifically quantify the statistical superiority of each entry point in correcting the labiomandibular fold (marionette lines) and jowls. |
| Ethics approval(s) |
Submitted 24/09/2024, Aln Shams University Faculty of Medicine, Research Ethics Committee (Ain Shams University Faculty of Medicine, El-Khalyfa El-Mamoun Street, Abbasya, Cairo, 11546, Egypt; +20 00201099223531; ecat@med.asu.edu.eg), ref: 00006379 |
| Health condition(s) or problem(s) studied | Aesthetic study requiring the clinical presence of moderate to severe lower facial aging, specifically defined by visible jowling equivalent to Grade 2 or higher on the Croma Jawline Sagging Assessment Scale, accompanied by the presence of clearly delineated labiomandibular folds (marionette lines). |
| Intervention | Patients were randomly assigned to one of two groups using a computer-generated sequence. Group A: Traditional Entry Point (TEP): This approach involved a subcutaneous dissection from the preauricular incision, extending anteriorly across the cheek to a vertical line drawn from the lateral canthus to the gonial angle of the mandible. The SMAS layer was incised at this specific line, followed by deep plane dissection, independent rotation and suspension of the SMAS flap, and subsequent skin redraping and excision. Group B: Preservation Entry Point (PEP): This approach featured subcutaneous dissection limited to less than 2.0 cm from the initial preauricular incision. The deep plane entry point was defined using the lateral "sailboat" modification. The skin and SMAS were entered as a single composite flap and mobilized extensively following the release of the retaining ligaments. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 28/06/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 45 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 96 |
| Key inclusion criteria | 1. Male and female patients 2. Aged between 45 and 70 years 3. Deemed medically fit for elective general anesthesia (ASA class I or II) 4. Aesthetic inclusion strictly required: 4.1. The clinical presence of moderate to severe lower facial aging 4.2. Specifically defined by visible jowling equivalent to Grade 2 or higher on the Croma Jawline Sagging Assessment Scale, accompanied by the presence of clearly delineated labiomandibular folds (marionette lines) |
| Key exclusion criteria | Patients with a history of any previous surgical facial rejuvenation were strictly excluded to prevent confounding anatomical alterations 2. Active tobacco smoking or nicotine use within the preceding four weeks 3. The presence of systemic connective tissue disorders 4. Uncontrolled diabetes mellitus (HbA1c > 7.0%) 5. A Body Mass Index (BMI) exceeding 30 kg/m2, and a clinical diagnosis of body dysmorphic disorder. |
| Date of first enrolment | 01/09/2024 |
| Date of final enrolment | 01/04/2026 |
Locations
Countries of recruitment
- Egypt
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 30/06/2026 | No | No | ||
| Other files | 30/06/2026 | No | No | ||
| Participant information sheet | 30/06/2026 | No | Yes | ||
| Participant information sheet | 30/06/2026 | No | Yes | ||
| Protocol file | version 3 | 30/06/2026 | No | No |
Additional files
- 49807_Protocol_V3.pdf
- Protocol file
- 49807_PIS [Egyptian].jpeg
- Participant information sheet
- 49807_PIS2 [Egyptian].jpeg
- Participant information sheet
- 49807_Certificate of Consent [Egyptian].jpeg
- Other files
- 49807_Informed Consent Form [Egyptian].jpeg
- Other files
Editorial Notes
30/06/2026: Study’s existence confirmed by the Aln Shams University Faculty of Medicine, Research Ethics Committee, Egypt.
