Buccal Mucosal Defect
Conditions
Keywords
Amniotic membrane, Buccal Mucosa, Buccal Mucosal Defect, Oral Mucosa Harvesting, Urethral Reconstruction, Oral Mucosal Wound Healing, Wound Healing
Brief summary
investigators use biological material to enhance recovery of oral cavity row area after harvesting a graft from it to use it in urethral reconstruction
Interventions
BIOLOGICALuse of amniotic membrane as a biological dressing over buccal mucosal raw area
use of amniotic membrane as a biological dressing over buccal mucosal raw area versus classic non closure technique after using BMG in urethroplasty for urethral stricture
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients were eligible for inclusion if they met the following criteria: * Adult patients (≥18 years) * Diagnosed with anterior urethral stricture requiring substitution urethroplasty * Planned use of buccal mucosal graft for urethral reconstruction * Ability to provide informed consent and comply with follow-up protocol
Exclusion criteria
* Patients were excluded if they had: * Previous buccal mucosal graft harvest * Active oral infection or mucosal pathology * History of oral malignancy or radiotherapy * Uncontrolled systemic disease (e.g., poorly controlled diabetes mellitus) * Immunosuppression or chronic steroid use * Known allergy to biological graft materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative donor-site epithelialization of the buccal donor site using Oral Mucosa Rating Scale (OMRS) | from the first day post op to 12 weeks | Oral Mucosa Rating Scale (OMRS): visual assessment of oral mucosa erythema, ulceration granulation, suppuration, and edema. * Erythema (Redness): from (0) normal to (3) severe * Ulceration: from (0) normal to (3) severe * Granulation Tissue (Healing/Chronic Inflammation): from (0) normal to (3) severe * Suppuration (Pus/Infection): from (0) normal to (3) severe * Edema (Swelling): from (0) normal to (3) severe |
| • Postoperative donor-site epithelialization of the buccal donor site using Landry Healing Index (HI) Scores | post op week 1 and 4 | Landry Healing Index (HI) Scores (1-5). The HI scores wound healing on a 1-to-5 scale, where a higher score indicates better, more accelerated healing: |
| Postoperative donor-site epithelialization of the buccal donor site using Early wound healing score | post op day 1 | EHS Component Breakdown (Total: 10 points): the higher the score indicate better healing * Clinical Signs of Re-epithelialization (CSR - 6 points max) * Clinical Signs of Hemostasis (CSH - 2 points max) * Clinical Signs of Inflammation (CSI - 2 points max) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain assessed by Visual Analogue Scale (VAS) | from first day post operative to 12 weeks | assessed by Visual Analogue Scale (VAS): form (0) which means no pain to (10) which means severe pain |
| Degree of oral aperture restriction (trismus), | Postoperative day 1 through week 12 | assessed by inter-incisor distance measurement |
| Oral health-related quality of life | Postoperative weeks 6 and 12 | assessed by Oral Health Impact Profile-14 (OHIP-14): higher scores indicate a more negative impact on your quality of life. Scoring Methods: There are two primary ways to calculate a score from the 5-point Likert scale (0 = Never, 1 = Hardly ever, 2 = Occasionally, 3 = Fairly often, 4 = Very often): * Additive Method: Sum the numerical values of all 14 answers. The total score ranges from 0 to 56. * Simple Count Method: Count the number of items where you answered "Occasionally" or more frequently. This score ranges from 0 to 14 and that's the method was used. |
Countries
Egypt
Outcome results
None listed