Postoperative PainNCT07523802
Management of Postoperative Pain Following Free Gingival Graft Harvesting Using Ora-Aid Versus Acrylic Palatal Stent
A study testing Ora-Aid Oral Wound Dressing and Acrylic Resin Palatal Stent in people with Postoperative Pain and Mucogingival Defects, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized clinical trial evaluates the effectiveness of Ora-Aid oral wound dressing compared to an acrylic palatal stent in managing postoperative pain following free gingival graft harvesting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Mucogingival Defects, Gingival Recessions
- What is being tested?
- Ora-Aid Oral Wound Dressing and Acrylic Resin Palatal Stent
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age
- Systemically healthy
- Patients with good oral hygiene
- Patients with mucogingival defects scheduled for free gingival graft (FGG)
Who cannot join
- Pregnancy or breastfeeding
- Severe gagging reflex
- Smokers
- Patients allergic to the materials used in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, 12613
Faculty of Dentistry Cairo University, 010 02159535, dentmail@dentistry.cu.edu.eg
About this study
Official title: Clinical Effectiveness of Oral Wound Dressing (Ora-Aid) in Comparison to Palatal Stent in Management of Postoperative Pain Following Free Gingival Graft Harvesting: A Randomized Clinical Trial.
This randomized clinical trial evaluates the effectiveness of Ora-Aid oral wound dressing compared to an acrylic palatal stent in managing postoperative pain following free gingival graft harvesting. Patients undergoing graft harvesting will be randomly assigned to receive either Ora-Aid dressing or a palatal stent at the donor site. The primary outcome is postoperative pain assessed using the Visual Analogue Scale (VAS). Secondary outcomes include analgesic consumption, wound size, patient satisfaction, and color match over a 42-day follow-up period.
Read the detailed description
Free gingival graft (FGG) harvesting is a commonly used periodontal procedure, but it is associated with significant postoperative pain and discomfort at the palatal donor site. Traditional management using acrylic palatal stents provides mechanical protection but may interfere with patient comfort and oral function.
Ora-Aid is a bio-adhesive hydrogel-based wound dressing designed for intraoral use, providing protection, reducing mechanical irritation, and potentially enhancing healing. Despite promising results in previous studies, there is limited evidence from randomized controlled trials comparing Ora-Aid with conventional palatal stents.
This study is a randomized, parallel-group clinical trial designed to compare the effectiveness of Ora-Aid and acrylic palatal stents in managing postoperative pain following FGG harvesting. Patients will be randomly allocated in a 1:1 ratio to either intervention group.
Pain will be assessed using the Visual Analogue Scale (VAS), while secondary outcomes include analgesic consumption, wound size, patient satisfaction, and color match at multiple postoperative time points (3, 7, 14, 21, and 42 days).
- Being tested
- Ora-Aid Oral Wound Dressing, Acrylic Resin Palatal Stent
- Keywords
- Free Gingival Graft, Palatal Donor Site, Ora-Aid, Oral Wound Dressing, Palatal Stent, Postoperative Pain Management, Wound Healing, Periodontal Surgery, Graft Harvesting, Mucogingival Therapy
- Medical subject headings
- Pain, Postoperative, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ora-Aid Oral Wound DressingOther
Also called Ora-Aid
Ora-Aid is a hydrogel-based, bioadhesive wound dressing designed for intraoral application. After harvesting the free gingival graft and managing hemostasis at the palatal donor site, the Ora-Aid patch will be cut and adjusted to fit the wound size. The dressing will be applied directly to the palatal wound and pressed gently for 10 seconds to aid adherence. It will then be fixed using 5/0 proline suture with a slinged horizontal figure-eight suture technique. The dressing provides a physical barrier over the wound, preventing mechanical irritation and reducing pain. Reapplication will occur every 3-5 days as needed until complete epithelialization is achieved (typically 10-14 days). The adhesive integrity of Ora-Aid typically lasts up to 72 hours.
Acrylic Resin Palatal StentDevice
Also called Palatal Stent, Acrylic Stent
A custom-made acrylic resin palatal stent is fabricated from an alginate impression and applied to the palatal donor site immediately after free gingival graft harvesting. The stent provides mechanical protection, stabilizes the blood clot, and reduces postoperative trauma. It is retained in place for approximately 2 weeks, with periodic removal for clinical evaluation of wound healing.
| Study group | Role | What they receive |
|---|---|---|
| Palatal Stent | Active comparator | Participants in this arm will receive an acrylic resin palatal stent to cover the palatal donor site immediately after free gingival graft harvesting. The stent will be fabricated using alginate impression with two Adams clasps and wax relief between the canine and second molar to accommodate gauze placement. The stent will be retained for two weeks and removed at day 3 for wound evaluation before being replaced. Receives: Device: Acrylic Resin Palatal Stent |
| Ora-Aid Oral Wound Dressing | Experimental | Ora-Aid is a hydrogel-based, bioadhesive wound dressing designed for intraoral application. After harvesting the free gingival graft and managing hemostasis at the palatal donor site, the Ora-Aid patch will be cut and adjusted to fit the wound size. The dressing will be applied directly to the palatal wound and pressed gently for 10 seconds to aid adherence. It will then be fixed using 5/0 proline suture with a slinged horizontal figure-eight suture technique. The dressing provides a physical barrier over the wound, preventing mechanical irritation and reducing pain. Reapplication will occur every 3-5 days as needed until complete epithelialization is achieved (typically 10-14 days). The adhesive integrity of Ora-Aid typically lasts up to 72 hours. Receives: Other: Ora-Aid Oral Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain, 1 indicates minimal pain, and 10 signifies severe pain. Patients will record their pain scores daily during the initial healing phase when pain is expected to be at its maximum level.
Measured: Days 1, 2, 3, 4, 5, 6, and 7 postoperatively
Secondary outcomes (4)
Analgesic Consumption
Indirect measurement of postoperative pain through mean consumption of analgesics, recorded in milligrams. Patients will document their analgesic intake and report whether they required additional painkillers due to palatal pain since the procedure
Measured: Daily for 7 days postoperatively
Wound Size
The size of the palatal donor site wound will be measured using a UNC-15 periodontal probe to the nearest 0.5 mm.
Measured: Day 0 (surgery day), Day 3, Day 7, Day 14, and Day 21
Patient Satisfaction with Healing Process
Patient satisfaction regarding postoperative discomfort and bleeding will be assessed using a questionnaire based on a Visual Analogue Scale (VAS) of 100 mm.
Measured: 1 week (Day 7) postoperatively
Color Match of Palatal Mucosa
The color of the palatal mucosa at the donor site will be assessed by comparing it with the adjacent and opposite side using an objective Visual Analogue Scale (VAS) score ranging from 0 to 10, where 0 indicates no color match and 10 indicates excellent color match with adjacent tissues. Assessment will be conducted by a clinician blinded to treatment group assignment.
Measured: Day 3, Day 7, Day 14, Day 21, and Day 42 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start14 Jan 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized clinical trial with a parallel-group design and 1:1 allocation ratio. Participants will be randomly assigned to one of two groups: the intervention group receiving Ora-Aid oral wound dressing at the palatal donor site, or the control group receiving an acrylic resin stent at the palatal donor site. Both groups will be followed for 42 days postoperatively.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sabry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523802
- Sponsor's protocol ID
- PER3-3-4
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Oral Wound Dressing (Ora-Aid) in Comparison to Palatal Stent in Management of Postoperative Pain Following Free Gingival Graft Harvesting: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07523802
- Acronym / sponsor ID
- PER3-3-4
- Keywords
- Free Gingival Graft, Palatal Donor Site, Ora-Aid, Oral Wound Dressing, Palatal Stent, Postoperative Pain Management, Wound Healing, Periodontal Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 13 Apr 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.
This randomized clinical trial evaluates the effectiveness of Ora-Aid oral wound dressing compared to an acrylic palatal stent in managing postoperative pain following free gingival graft harvesting. Patients undergoing graft harvesting will be randomly assigned to receive either Ora-Aid dressing or a palatal stent at the donor site. The primary outcome is postoperative pain assessed using the Visual Analogue Scale (VAS). Secondary outcomes include analgesic consumption, wound size, patient satisfaction, and color match over a 42-day follow-up period.
Detailed description
Free gingival graft (FGG) harvesting is a commonly used periodontal procedure, but it is associated with significant postoperative pain and discomfort at the palatal donor site. Traditional management using acrylic palatal stents provides mechanical protection but may interfere with patient comfort and oral function.
Ora-Aid is a bio-adhesive hydrogel-based wound dressing designed for intraoral use, providing protection, reducing mechanical irritation, and potentially enhancing healing. Despite promising results in previous studies, there is limited evidence from randomized controlled trials comparing Ora-Aid with conventional palatal stents.
This study is a randomized, parallel-group clinical trial designed to compare the effectiveness of Ora-Aid and acrylic palatal stents in managing postoperative pain following FGG harvesting. Patients will be randomly allocated in a 1:1 ratio to either intervention group.
Pain will be assessed using the Visual Analogue Scale (VAS), while secondary outcomes include analgesic consumption, wound size, patient satisfaction, and color match at multiple postoperative time points (3, 7, 14, 21, and 42 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized clinical trial with a parallel-group design and 1:1 allocation ratio. Participants will be randomly assigned to one of two groups: the intervention group receiving Ora-Aid oral wound dressing at the palatal donor site, or the control group receiving an acrylic resin stent at the palatal donor site. Both groups will be followed for 42 days postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Palatal Stent | Active comparator | Device: Acrylic Resin Palatal StentParticipants in this arm will receive an acrylic resin palatal stent to cover the palatal donor site immediately after free gingival graft harvesting. The stent will be fabricated using alginate impression with two Adams clasps and wax relief between the canine and second molar to accommodate gauze placement. The stent will be retained for two weeks and removed at day 3 for wound evaluation before being replaced. |
| Ora-Aid Oral Wound Dressing | Experimental | Other: Ora-Aid Oral Wound DressingOra-Aid is a hydrogel-based, bioadhesive wound dressing designed for intraoral application. After harvesting the free gingival graft and managing hemostasis at the palatal donor site, the Ora-Aid patch will be cut and adjusted to fit the wound size. The dressing will be applied directly to the palatal wound and pressed gently for 10 seconds to aid adherence. It will then be fixed using 5/0 proline suture with a slinged horizontal figure-eight suture technique. The dressing provides a physical barrier over the wound, preventing mechanical irritation and reducing pain. Reapplication will occur every 3-5 days as needed until complete epithelialization is achieved (typically 10-14 days). The adhesive integrity of Ora-Aid typically lasts up to 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years of age
- Systemically healthy
- Patients with good oral hygiene
- Patients with mucogingival defects scheduled for free gingival graft (FGG)
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding
- Severe gagging reflex
- Smokers
- Patients allergic to the materials used in the study
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 |
|---|---|---|
| Ora-Aid Oral Wound DressingAlso: Ora-AidOra-Aid is a hydrogel-based, bioadhesive wound dressing designed for intraoral application. After harvesting the free gingival graft and managing hemostasis at the palatal donor site, the Ora-Aid patch will be cut and adjusted to fit the wound size. The dressing will be applied directly to the palatal wound and pressed gently for 10 seconds to aid adherence. It will then be fixed using 5/0 proline suture with a slinged horizontal figure-eight suture technique. The dressing provides a physical barrier over the wound, preventing mechanical irritation and reducing pain. Reapplication will occur every 3-5 days as needed until complete epithelialization is achieved (typically 10-14 days). The adhesive integrity of Ora-Aid typically lasts up to 72 hours. | Other | Ora-Aid Oral Wound Dressing |
| Acrylic Resin Palatal StentAlso: Palatal Stent, Acrylic StentA custom-made acrylic resin palatal stent is fabricated from an alginate impression and applied to the palatal donor site immediately after free gingival graft harvesting. The stent provides mechanical protection, stabilizes the blood clot, and reduces postoperative trauma. It is retained in place for approximately 2 weeks, with periodic removal for clinical evaluation of wound healing. | Device | Palatal Stent |
Primary outcome
Postoperative Pain
Time frame: Days 1, 2, 3, 4, 5, 6, and 7 postoperatively
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain, 1 indicates minimal pain, and 10 signifies severe pain. Patients will record their pain scores daily during the initial healing phase when pain is expected to be at its maximum level.
4 secondary outcomes
Analgesic Consumption
Time frame: Daily for 7 days postoperatively
Wound Size
Time frame: Day 0 (surgery day), Day 3, Day 7, Day 14, and Day 21
Patient Satisfaction with Healing Process
Time frame: 1 week (Day 7) postoperatively
Color Match of Palatal Mucosa
Time frame: Day 3, Day 7, Day 14, Day 21, and Day 42 postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ora-Aid Oral Wound Dressing and Acrylic Resin Palatal Stent in people with Postoperative Pain and Mucogingival Defects, run by Cairo 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Apr 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: Days 1, 2, 3, 4, 5, 6, and 7 postoperatively). 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 14 Apr 2026.