Effect of Frankincense Versus Palatal Stent on Palatal Donor Site Healing

N/AActive Not RecruitingNCT07772011

Cairo University28 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

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

Time frame: Day 30

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: Days 3, 7, 14, 21, and 30

Postoperative Bleeding