Effect of Frankincense Versus Palatal Stent on Palatal Donor Site Healing

NCT07772011 | Active Not Recruiting

• 1 other identifier: PER 3_3_1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Palatal Donor Site Wound Healing

Keywords

Frankincense; Boswellia serrata; Palatal wound healing; Palatal donor site; Free gingival graft; Palatal stent

Outcome Measures

Primary Outcomes (1)

• 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

  Day 30

Secondary Outcomes (5)

• Pain Perception

  Days 3, 7, and 14

• Wound Epithelialization

  Days 14, 21, and 30

• Wound Surface Area

  up to 30 days

• Wound Healing

  Days 3, 7, 14, 21, and 30

• Postoperative Bleeding

  Days 3, 7, and 14

Study Arms (2)

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.

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.

Device: Palatal stent

Interventions

Frankincense Gel DRUG

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.

Frankincense Gel + Palatal Stent

Palatal stent DEVICE

A palatal stent will be placed over the palatal donor site after free gingival graft harvesting to provide postoperative protection.

Frankincense Gel + Palatal Stent; Palatal Stent Only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40790022 BACKGROUND

Study Officials

• HAWRA FUAD ALI Mulla ALI, BDS

  Cairo University

  PRINCIPAL INVESTIGATOR

• Dr.Manal Hosny

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor and statistician will be blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Student - Periodontology - Cairo University

Model Details: Participants will be randomly assigned in a 1:1 ratio to two parallel groups: frankincense gel with palatal stent or palatal stent only

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 19, 2026
• Study Start: April 30, 2026
• Primary Completion: May 30, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)