Palatal Donor Site Wound Healing
Conditions
Keywords
Frankincense, Boswellia serrata, Palatal wound healing, Palatal donor site, Free gingival graft, Palatal stent
Brief 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 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.
Interventions
DRUGFrankincense Gel
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.
DEVICEPalatal stent
A palatal stent will be placed over the palatal donor site after free gingival graft harvesting to provide postoperative protection.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor and statistician will be blinded to group allocation.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Scores Assessed Using a 3-Item, 7-Point Questionnaire | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perception | Days 3, 7, and 14 | 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. |
| Wound Epithelialization | Days 14, 21, and 30 | 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. |
| Wound Surface Area | up to 30 days | Wound surface area will be assessed from standardized oral photographs using image analysis software and reported in square millimeters. |
| Wound Healing | Days 3, 7, 14, 21, and 30 | 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). |
| Postoperative Bleeding | Days 3, 7, and 14 | — |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORHAWRA FUAD ALI Mulla ALI, BDS
Cairo University
STUDY_CHAIRDr.Manal Hosny
Cairo University
Outcome results
None listed