Heal WoundNCT07072182
Evaluation of the Effect of Different Biomaterials on Palatal Wound Healing.
A study testing Palatal wound will be covered with Ora-aid patch, Palatal wound will be covered with Composite stent and Palatal wound will be covered with PRF in people with Heal Wound and VAS Will be Used to Assess Pain Postoperative, run by Fatma saad saad mahmoud elsherbini at 1 site in Egypt.
Trial summary
All study subjects will sign written informal consent form before enrolment. They will be divided into four groups, 10 patients each: Group I: Palatal wound will be left to heal spontaneously, Group II: Palatal wound will be covered with Composite stent, Group III: Palatal wound will be covered with PRF, Group IV… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Heal Wound, VAS Will be Used to Assess Pain Postoperative
- What is being tested?
- Palatal wound will be covered with Ora-aid patch, Palatal wound will be covered with Composite stent and Palatal wound will be covered with PRF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2025to 20 Jun 2025
- Phase
- Interventional
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are indicated for soft tissue augmentation procedures, either with root coverage or to increase the deficient keratinized tissue,
- Medically free patients,
- Non-smokers and
- Patients with good oral hygiene. Exclusion Criteria:-
- Pregnant or lactating females,
- Patients with untreated periodontal condition and
- Patients with uncontrolled systemic condition.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university Faculty of dentistry
Al Mansurah, Dakhlia, 35516
About this study
Official title: Evaluation of the Effect of Different Biomaterials on Palatal Wound Healing. A Randomized Controlled Clinical Study
All study subjects will sign written informal consent form before enrolment.
They will be divided into four groups, 10 patients each:
- Group I: Palatal wound will be left to heal spontaneously,
- Group II: Palatal wound will be covered with Composite stent,
- Group III: Palatal wound will be covered with PRF,
- Group IV: Palatal wound will be covered with Ora-aid patch. III- Surgical Procedures: -
- After harvesting the palatal soft tissue graft with the standardized dimensions (12 × 7 mm) of the graft for all patients. Graft thickness was standardized as well to be approximately 1.5 to 2 mm and confirmed with a caliper at 3 points (ends and centre of the graft). Fixing of the graft at the recipient site will be performed, back to the donor site for management, the blood clot will be wiped with gauze, then placement of different materials according to each group.
- The dressing will be then pressed gently for 10 seconds, to aid its adherence to the wound. Fixation of the patch will be followed, using 5/0 propylene suture, with performing sling horizontal figure eight suture technique.
- Being tested
- Palatal wound will be covered with Ora-aid patch, Palatal wound will be covered with Composite stent, Palatal wound will be covered with PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal wound will be covered with Ora-aid patchDevice
Also called ora aid
Palatal wound will be covered with Ora-aid patch
Palatal wound will be covered with Composite stentDevice
Palatal wound will be covered with Composite stent
Palatal wound will be covered with PRFCombination product
Also called prf
Palatal wound will be covered with PRF
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Palatal wound will be left to heal spontaneously |
| study group 1 | Experimental | Palatal wound will be covered with Composite stent Receives: Device: Palatal wound will be covered with Composite stent |
| study group 2 | Experimental | Palatal wound will be covered with PRF Receives: Combination Product: Palatal wound will be covered with PRF |
| study group 3 | Experimental | Palatal wound will be covered with Ora-aid patch Receives: Device: Palatal wound will be covered with Ora-aid patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing assessment
The parameters of tissue color, bleeding response to palpation, presence of granulation tissue, characteristics of the incision margins, and the presence of suppuration were evaluated as this index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing gets a score of 5.
Measured: From enrollment to the end of treatment at 4 weeks
Pain using the visual analogue scale
Patients were asked about their pain levels, swelling, and other experiences related to the surgical techniques and instruments to assess postoperative pain. The perceived discomfort was rated using a VAS, which is marked at two endpoints: "no discomfort" at one end (score of 0) and "unbearable discomfort" at the other end (score of 10). Patients completed the questionnaires on the 1st, 2nd, 4th, 7th, and 14th days after their surgery
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
Patient satisfaction through direct communication
Patient satisfaction (PS) was evaluated using a three-point rating scale: 3 for fully satisfied, 2 for satisfied, and 1 for unsatisfied. Each patient was asked about their satisfaction with the following patient-centered criteria: root coverage achieved, relief from dentinal hypersensitivity, color of the gingiva, shape and contour of the gingiva, surgical procedure (including pain during surgery and discomfort related to the duration of the procedure and the operator's handling), post-surgical phase (including pain, swelling, and any postoperative complications), and cost-effectiveness (patients were asked if they felt the treatment justified the time and money spent). This approach aimed to gather comprehensive feedback on the overall patient experience
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start20 Mar 2025
- Primary completion20 May 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heal WoundStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatma saad saad mahmoud elsherbini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma saad saad mahmoud elsherbini, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072182
- Sponsor's protocol ID
- M0101025OM
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Biomaterials on Palatal Wound Healing. A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07072182
- Acronym / sponsor ID
- M0101025OM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fatma saad saad mahmoud elsherbiniUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 18 Jul 2025 (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.
All study subjects will sign written informal consent form before enrolment.
They will be divided into four groups, 10 patients each:
- Group I: Palatal wound will be left to heal spontaneously,
- Group II: Palatal wound will be covered with Composite stent,
- Group III: Palatal wound will be covered with PRF,
- Group IV: Palatal wound will be covered with Ora-aid patch. III- Surgical Procedures: -
- After harvesting the palatal soft tissue graft with the standardized dimensions (12 × 7 mm) of the graft for all patients. Graft thickness was standardized as well to be approximately 1.5 to 2 mm and confirmed with a caliper at 3 points (ends and centre of the graft). Fixing of the graft at the recipient site will be performed, back to the donor site for management, the blood clot will be wiped with gauze, then placement of different materials according to each group.
- The dressing will be then pressed gently for 10 seconds, to aid its adherence to the wound. Fixation of the patch will be followed, using 5/0 propylene suture, with performing sling horizontal figure eight suture technique.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Palatal wound will be left to heal spontaneously |
| study group 1 | Experimental | Device: Palatal wound will be covered with Composite stentPalatal wound will be covered with Composite stent |
| study group 2 | Experimental | Combination Product: Palatal wound will be covered with PRFPalatal wound will be covered with PRF |
| study group 3 | Experimental | Device: Palatal wound will be covered with Ora-aid patchPalatal wound will be covered with Ora-aid patch |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients who are indicated for soft tissue augmentation procedures, either with root coverage or to increase the deficient keratinized tissue,
- Medically free patients,
- Non-smokers and
- Patients with good oral hygiene. Exclusion Criteria:-
- Pregnant or lactating females,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Palatal wound will be covered with Ora-aid patchAlso: ora aidPalatal wound will be covered with Ora-aid patch | Device | study group 3 |
| Palatal wound will be covered with Composite stentPalatal wound will be covered with Composite stent | Device | study group 1 |
| Palatal wound will be covered with PRFAlso: prfPalatal wound will be covered with PRF | Combination product | study group 2 |
Primary outcome
Wound healing assessment
Time frame: From enrollment to the end of treatment at 4 weeks
The parameters of tissue color, bleeding response to palpation, presence of granulation tissue, characteristics of the incision margins, and the presence of suppuration were evaluated as this index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing gets a score of 5.
Pain using the visual analogue scale
Time frame: From enrollment to the end of treatment at 4 weeks
Patients were asked about their pain levels, swelling, and other experiences related to the surgical techniques and instruments to assess postoperative pain. The perceived discomfort was rated using a VAS, which is marked at two endpoints: "no discomfort" at one end (score of 0) and "unbearable discomfort" at the other end (score of 10). Patients completed the questionnaires on the 1st, 2nd, 4th, 7th, and 14th days after their surgery
1 secondary outcome
Patient satisfaction through direct communication
Time frame: From enrollment to the end of treatment at 4 weeks
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 18 Jul 2025.
- Individual participant dataSharing planned: No
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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 study testing Palatal wound will be covered with Ora-aid patch, Palatal wound will be covered with Composite stent and Palatal wound will be covered with PRF in people with Heal Wound and VAS Will be Used to Assess Pain Postoperative, run by Fatma saad saad mahmoud elsherbini 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 7 inclusion and 0 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 18 Jul 2025. 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.
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?
Wound healing assessment (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 2 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 18 Jul 2025.