Buccal Mucosal DefectPhase 4NCT07824596
The Role of Amniotic Membrane in Promoting Rapid Recovery of Buccal Mucosal Defect After Harvesting Oral Mucosa for Urethral Reconstruction
A Phase 4 study testing use of amniotic membrane as a biological dressing over buccal mucosal raw area in people with Buccal Mucosal Defect, run by Zagazig University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Buccal Mucosal Defect
- What is being tested?
- use of amniotic membrane as a biological dressing over buccal mucosal raw area
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2025to 10 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
investigators use biological material to enhance recovery of oral cavity row area after harvesting a graft from it to use it in urethral reconstruction
- Conditions
- Buccal Mucosal Defect
- Being tested
- use of amniotic membrane as a biological dressing over buccal mucosal raw area
- Keywords
- Amniotic membrane, Buccal Mucosa, Buccal Mucosal Defect, Oral Mucosa Harvesting, Urethral Reconstruction, Oral Mucosal Wound Healing, Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of amniotic membrane as a biological dressing over buccal mucosal raw areaBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Amniotic membrane coverage group | Active comparator | Application of amniotic membrane in buccal graft site after harvesting buccal mucosa graft for using it in uretheroplasty Receives: Biological: use of amniotic membrane as a biological dressing over buccal mucosal raw area |
| Classic non closure technique | No intervention | Classic non closure technique of buccal graft site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative donor-site epithelialization of the buccal donor site using Oral Mucosa Rating Scale (OMRS)
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
Measured: from the first day post op to 12 weeks
• Postoperative donor-site epithelialization of the buccal donor site using Landry Healing Index (HI) Scores
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:
Measured: post op week 1 and 4
Postoperative donor-site epithelialization of the buccal donor site using Early wound healing score
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)
Measured: post op day 1
Secondary outcomes (3)
Postoperative pain assessed by Visual Analogue Scale (VAS)
assessed by Visual Analogue Scale (VAS): form (0) which means no pain to (10) which means severe pain
Measured: from first day post operative to 12 weeks
Degree of oral aperture restriction (trismus),
assessed by inter-incisor distance measurement
Measured: Postoperative day 1 through week 12
Oral health-related quality of life
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.
Measured: Postoperative weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start22 Jun 2025
- Primary completion25 Apr 2026
- Study completion10 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buccal Mucosal DefectStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, mohamed elsayed mousa mohamed owis, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824596
- Sponsor's protocol ID
- 1350
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Amniotic Membrane in Promoting Rapid Recovery of Buccal Mucosal Defect After Harvesting Oral Mucosa for Urethral Reconstruction
- ClinicalTrials.gov ID
- NCT07824596
- Acronym / sponsor ID
- 1350
- Conditions
- Buccal Mucosal Defect
- Keywords
- Amniotic membrane, Buccal Mucosa, Buccal Mucosal Defect, Oral Mucosa Harvesting, Urethral Reconstruction, Oral Mucosal Wound Healing, Wound Healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
investigators use biological material to enhance recovery of oral cavity row area after harvesting a graft from it to use it in urethral reconstruction
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic membrane coverage group | Active comparator | Biological: use of amniotic membrane as a biological dressing over buccal mucosal raw areaApplication of amniotic membrane in buccal graft site after harvesting buccal mucosa graft for using it in uretheroplasty |
| Classic non closure technique | No intervention | –Classic non closure technique of buccal graft site |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients were eligible for inclusion if they met the following criteria:
Key exclusion criteria (7 listed)
- Patients were excluded if they had:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of amniotic membrane as a biological dressing over buccal mucosal raw areause 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 | Biological | Amniotic membrane coverage group |
Primary outcome
Postoperative donor-site epithelialization of the buccal donor site using Oral Mucosa Rating Scale (OMRS)
Time frame: 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
Time frame: 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
Time frame: 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)
3 secondary outcomes
Postoperative pain assessed by Visual Analogue Scale (VAS)
Time frame: from first day post operative to 12 weeks
Degree of oral aperture restriction (trismus),
Time frame: Postoperative day 1 through week 12
Oral health-related quality of life
Time frame: Postoperative weeks 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing use of amniotic membrane as a biological dressing over buccal mucosal raw area in people with Buccal Mucosal Defect, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative donor-site epithelialization of the buccal donor site using Oral Mucosa Rating Scale (OMRS) (time frame: from the first day post op to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.