Palatal Donor Site Wound HealingNCT07772011
Effect of Frankincense Versus Palatal Stent on Palatal Donor Site Healing
A study testing Frankincense Gel and Palatal stent in people with Palatal Donor Site Wound Healing, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial will evaluate the effect of a natural frankincense-based gel on healing of the palatal donor site after soft tissue graft harvesting. A total of 28 adult participants requiring a free gingival graft or connective tissue graft will be randomly assigned in a 1:1 ratio to one of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Palatal Donor Site Wound Healing
- What is being tested?
- Frankincense Gel and Palatal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2026to Mar 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Patients scheduled for a free gingival graft or connective tissue graft requiring a palatal donor site.
- ASA physical status I-II
Who cannot join
- Known allergy or hypersensitivity to frankincense, Boswellia species, or frankincense formulation excipients.
- Current smoker or tobacco user.
- Uncontrolled systemic disease, such as uncontrolled diabetes mellitus.
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Frankincense Versus Palatal Stent on Palatal Donor Site Healing: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial will evaluate the effect of a natural frankincense-based gel on healing of the palatal donor site after soft tissue graft harvesting. A total of 28 adult participants requiring a free gingival graft or connective tissue graft will be randomly assigned in a 1:1 ratio to one of two groups. The intervention group will receive topical frankincense gel applied to the palatal wound together with a palatal stent, while the control group will receive a palatal stent only. Participants will be followed for 30 days. The study will assess patient satisfaction, postoperative pain, wound epithelialization, wound surface area, and wound healing
Read the detailed description
Participants undergoing palatal soft tissue harvesting for periodontal plastic surgical procedures will be recruited from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University.
Eligible participants will be randomly allocated in a 1:1 ratio into two parallel groups. In the experimental group, a continuous thin layer of natural frankincense-based gel will be applied topically to the denuded palatal donor site following graft harvesting, followed by placement of a palatal stent. In the comparator group, the palatal donor site will be managed using a palatal stent only.
The frankincense gel is prepared using Boswellia serrata extract in an aqueous gel formulation. The palatal soft tissue graft will be harvested using a standardized surgical approach, and graft dimensions and residual palatal mucosal thickness will be recorded.
Participants will be followed for 30 days. Patient satisfaction will be assessed using a 7-point Likert scale. Postoperative pain will be evaluated using a Visual Analog Scale from 0 to 10. Wound epithelialization will be assessed using 3% hydrogen peroxide, wound surface area will be evaluated from clinical photographs using image analysis, and wound healing will be evaluated using the Landry, Turnbull, and Howley Healing Index.
- Conditions
- Palatal Donor Site Wound Healing
- Being tested
- Frankincense Gel, Palatal stent
- Keywords
- Frankincense, Boswellia serrata, Palatal wound healing, Palatal donor site, Free gingival graft, Palatal stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frankincense GelDrug
Topical application of a natural frankincense-based gel containing Boswellia serrata to the denuded palatal donor site after free gingival graft harvesting. The gel is applied as a continuous thin layer and followed by placement of a palatal stent.
Palatal stentDevice
A palatal stent will be placed over the palatal donor site after free gingival graft harvesting to provide postoperative protection.
| Study group | Role | What they receive |
|---|---|---|
| Frankincense Gel + Palatal Stent | Experimental | Topical application of frankincense gel to the palatal donor site followed by placement of a palatal stent after free gingival graft harvesting. Receives: Drug: Frankincense Gel; Device: Palatal stent |
| Palatal Stent Only | Active comparator | Palatal stent applied to the palatal donor site after free gingival graft harvesting without frankincense gel. Receives: Device: Palatal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Scores Assessed Using a 3-Item, 7-Point Questionnaire
Patient satisfaction will be assessed using a 3-item questionnaire evaluating willingness to undergo the same procedure again, willingness to recommend the surgical procedure to others, and overall satisfaction with the results.
Each item will be rated on a 7-point scale ranging from 1 to 7, where higher scores indicate greater willingness or satisfaction.
The score for each questionnaire item will be reported separately
Measured: Day 30
Secondary outcomes (5)
Pain Perception
Postoperative pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates severe pain.
Measured: Days 3, 7, and 14
Wound Epithelialization
Wound epithelialization will be assessed using 3% hydrogen peroxide. Complete epithelialization will be recorded according to the presence or absence of bubbling over the wound surface.
Measured: Days 14, 21, and 30
Wound Surface Area
Wound surface area will be assessed from standardized oral photographs using image analysis software and reported in square millimeters.
Measured: up to 30 days
Wound Healing
Wound healing will be assessed using the Landry, Turnbull, and Howley Healing Index, with scores ranging from 1 (very poor healing) to 5 (excellent healing).
Measured: Days 3, 7, 14, 21, and 30
Postoperative Bleeding
Measured: Days 3, 7, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start30 Apr 2026
- Primary completion30 May 2026
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palatal Donor Site Wound HealingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: frankincense gel with palatal stent or palatal stent only
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAWRA FUAD ALI GHULOOM MULLA ALI, Cairo University
- Investigators
- HAWRA FUAD ALI Mulla ALI, BDS, Principal investigator, Cairo UniversityDr.Manal Hosny, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772011
- Sponsor's protocol ID
- PER 3_3_1
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the research team. Access to the final study data will be limited to the principal investigator and study supervisors in order to maintain participant confidentiality
Publications
Abdelrehim SMM, Elbattawy WA, Ashour OAM. The effect of nano-bio fusion gingival gel versus palatal stent on the palatal wound healing after harvesting free gingival graft: a randomized controlled clinical trial. BDJ Open. 2025 Aug 11;11(1):73. doi: 10.1038/s41405-025-00360-6.
PubMed 40790022
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Frankincense Versus Palatal Stent on Palatal Donor Site Healing: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07772011
- Acronym / sponsor ID
- PER 3_3_1
- Conditions
- Palatal Donor Site Wound Healing
- Keywords
- Frankincense, Boswellia serrata, Palatal wound healing, Palatal donor site, Free gingival graft, Palatal stent
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Aug 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 controlled clinical trial will evaluate the effect of a natural frankincense-based gel on healing of the palatal donor site after soft tissue graft harvesting. A total of 28 adult participants requiring a free gingival graft or connective tissue graft will be randomly assigned in a 1:1 ratio to one of two groups. The intervention group will receive topical frankincense gel applied to the palatal wound together with a palatal stent, while the control group will receive a palatal stent only. Participants will be followed for 30 days. The study will assess patient satisfaction, postoperative pain, wound epithelialization, wound surface area, and wound healing
Detailed description
Participants undergoing palatal soft tissue harvesting for periodontal plastic surgical procedures will be recruited from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University.
Eligible participants will be randomly allocated in a 1:1 ratio into two parallel groups. In the experimental group, a continuous thin layer of natural frankincense-based gel will be applied topically to the denuded palatal donor site following graft harvesting, followed by placement of a palatal stent. In the comparator group, the palatal donor site will be managed using a palatal stent only.
The frankincense gel is prepared using Boswellia serrata extract in an aqueous gel formulation. The palatal soft tissue graft will be harvested using a standardized surgical approach, and graft dimensions and residual palatal mucosal thickness will be recorded.
Participants will be followed for 30 days. Patient satisfaction will be assessed using a 7-point Likert scale. Postoperative pain will be evaluated using a Visual Analog Scale from 0 to 10. Wound epithelialization will be assessed using 3% hydrogen peroxide, wound surface area will be evaluated from clinical photographs using image analysis, and wound healing will be evaluated using the Landry, Turnbull, and Howley Healing Index.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: frankincense gel with palatal stent or palatal stent only
| Arm | Type | Receives |
|---|---|---|
| Frankincense Gel + Palatal Stent | Experimental | Drug: Frankincense Gel, Device: Palatal stentTopical application of frankincense gel to the palatal donor site followed by placement of a palatal stent after free gingival graft harvesting. |
| Palatal Stent Only | Active comparator | Device: Palatal stentPalatal stent applied to the palatal donor site after free gingival graft harvesting without frankincense gel. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years.
- Patients scheduled for a free gingival graft or connective tissue graft requiring a palatal donor site.
- ASA physical status I-II
Key exclusion criteria (4 listed)
- Known allergy or hypersensitivity to frankincense, Boswellia species, or frankincense formulation excipients.
- Current smoker or tobacco user.
- Uncontrolled systemic disease, such as uncontrolled diabetes mellitus.
- Pregnant or lactating females
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 |
|---|---|---|
| Frankincense GelTopical application of a natural frankincense-based gel containing Boswellia serrata to the denuded palatal donor site after free gingival graft harvesting. The gel is applied as a continuous thin layer and followed by placement of a palatal stent. | Drug | Frankincense Gel + Palatal Stent |
| Palatal stentA palatal stent will be placed over the palatal donor site after free gingival graft harvesting to provide postoperative protection. | Device | Frankincense Gel + Palatal Stent, Palatal Stent Only |
Primary outcome
Patient Satisfaction Scores Assessed Using a 3-Item, 7-Point Questionnaire
Time frame: Day 30
Patient satisfaction will be assessed using a 3-item questionnaire evaluating willingness to undergo the same procedure again, willingness to recommend the surgical procedure to others, and overall satisfaction with the results. Each item will be rated on a 7-point scale ranging from 1 to 7, where higher scores indicate greater willingness or satisfaction. The score for each questionnaire item will be reported separately
5 secondary outcomes
Pain Perception
Time frame: Days 3, 7, and 14
Wound Epithelialization
Time frame: Days 14, 21, and 30
Wound Surface Area
Time frame: up to 30 days
Wound Healing
Time frame: Days 3, 7, 14, 21, and 30
Postoperative Bleeding
Time frame: Days 3, 7, and 14
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 19 Aug 2026.
- Background: PubMed 40790022Abdelrehim SMM, Elbattawy WA, Ashour OAM. The effect of nano-bio fusion gingival gel versus palatal stent on the palatal wound healing after harvesting free gingival graft: a randomized controlled clinical trial. BDJ Open. 2025 Aug 11;11(1):73. doi: 10.1038/s41405-025-00360-6.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the research team. Access to the final study data will be limited to the principal investigator and study supervisors in order to maintain participant confidentiality
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Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel
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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.
HAWRA FUAD ALI Mulla ALI, BDS principal investigator
Cairo University
Dr.Manal Hosny study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frankincense Gel and Palatal stent in people with Palatal Donor Site Wound Healing, 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 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 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?
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?
Patient Satisfaction Scores Assessed Using a 3-Item, 7-Point Questionnaire (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07772011, which also lists 1 linked publication.
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 19 Aug 2026.