Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203, Egypt
Not Yet Recruiting
NCT Number: NCT07590427
Periosteal Muscular Flap in Reconstruction of Small and Medium Sized Defects at Floor of the Mouth
Background: Rebuilding head and neck defects is a chief challenge to the maxillofacial surgeons especially after cancer resection, trauma, infection and craniofacial deformities. Earlier, the use of obturators for many years has been a successful treatment plan. However, recently several surgical modalities are available for the restoration of such defects as locoregional or microvascular free flaps.
Aim: To assess the reliability of the lateral periosteal-muscular flap in the reconstruction of small and medium sized floor of the mouth defects.
Main outcome: To evaluate functional outcomes (Including speech, tongue mobility, deglutition, flap viability), pain, complications such as trismus, flap necrosis, dehiscence, infection, fistula formation or donor site morbidity and aesthetic outcomes. Mean harvesting time and flap dimensions will be recorded.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
30 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients requiring reconstruction of small and medium sized FOM defects.
Exclusion criteria
- Previous neck dissection.
- Previous radiotherapy in the maxillofacial region.
- Uncontrolled diseases that may contraindicate the surgery
Treatment and study plan
Lateral periosteal-muscular flap
ProcedureFollowing tumor resection and neck dissection, the floor of mouth defect was assessed, and the marginal mandibular nerve was carefully preserved. An inferiorly based rectangular periosteal flap was designed on the lateral surface of the mandible. The flap was elevated using a periosteal elevator while maintaining its inferior vascular pedicle. Additional lingual dissection was performed when extra length was required. The flap was then rotated to the lingual side of the mandible to reconstruct the floor of mouth defect and secured using 3/0 Vicryl sutures. Saline irrigation was used intraorally to confirm complete sealing without neck leakage. Flap dimensions and harvesting time were recorded.
Primary outcomes
-
Change in pain scores
Time frame: up to 6 months
Pain will be evaluated using a 10-cm visual analogue scale (VAS).
-
Change in aesthetic assessment
Time frame: up to 6 months
The aesthetic results will be assessed as excellent (E), good (G), acceptable (A) and poor (P).
Secondary outcomes
-
post-operative complication
Time frame: up to 6 months
Any signs of post operative complications will be recorded
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Alexandria University
Other
Registry information
Official study title
the Versatility of Periosteal Muscular Flap in Reconstruction of Small and Medium Sized Defects at Floor of the Mouth
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- May 15, 2026
- Registry last updated
- May 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.