MEBO Bio-Dressing on Patient-Reported Outcomes and Tissue Healing Following Rotary Gingival Depigmentation

NCT07876921 | Not Yet Recruiting

• 1 other identifier: CU-DENT-PERIO-MEBO-2026
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized, single-blind, parallel-group clinical trial is to evaluate the clinical efficacy of Moist Exposed Burn Ointment (MEBO) as a biological topical dressing compared to open secondary healing (no dressing) following rotary gingival depigmentation in adult patients. The study aims to investigate whether the application of MEBO reduces postoperative pain intensity, decreases rescue analgesic reliance, accelerates soft-tissue wound healing, and improves oral health-related quality of life over a 1-month follow-up period.

Conditions

Gingival Hyperpigmentation; Oral Health-Related Quality of Life; Wound Healing

Keywords

gingival depigmentation; MEBO; bio-dressing

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Intensity

  Measured using a Visual Analogue Scale (VAS) score ranging from 0 (indicating no pain) to 10 (indicating worst imaginable unbearable pain).

  Daily at 8:00 PM for 7 consecutive post-operative days

• Total Rescue Analgesic Consumption

  Cumulative number and total dosage in milligrams of Ibuprofen 600 mg tablets consumed by the participant for post-operative pain control.

  Daily for 7 consecutive post-operative days

Secondary Outcomes (2)

• Clinical Soft-Tissue Wound Healing

  Baseline (Day 0), and post-operatively at Days 3, 7, 14, 21, and 30

• Oral Health-Related Quality of Life (OHIP-14)

  Baseline (Day 0) and Day 7 post-operatively

Other Outcomes (1)

• Gingival Color Match Score

  Day 14 and Day 30 post-operatively

Study Arms (2)

MEBO Bio-Dressing Group

EXPERIMENTAL

Rotary gingival depigmentation using a polishing brush followed by topical application of MEBO ointment as a protective biological dressing 3 times daily for 7 days.

Drug: MEBO Ointment

Control Group (Open Secondary Healing)

NO INTERVENTION

Rotary gingival depigmentation using a polishing brush followed by open secondary healing without any topical dressing application.

Interventions

MEBO Ointment DRUG

Topical lipid-based ointment applied directly over the de-epithelialized gingival wound immediately post-surgery and re-applied topically by the patient 3 times daily for 7 days.

MEBO Bio-Dressing Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Systemically healthy adult patients aged 18 to 50 years. 2. Presence of bilateral, symmetrical physiological gingival hyperpigmentation (Dummett Oral Pigmentation Index score \>= 2) requiring esthetic treatment.
• \. Good oral hygiene status (Plaque Index \<= 1). 4. Patients willing and able to comply with trial protocols, oral hygiene instructions, daily diary recording, and scheduled follow-up visits.
• \. Signed written informed consent obtained prior to study enrollment.

You may not qualify if:

• \. Smokers or patients using any form of tobacco/nicotine products. 2. Pregnant, lactating, or planning pregnancy during the trial period. 3. Systemic diseases affecting wound healing or bone metabolism (e.g., uncontrolled diabetes mellitus, autoimmune disorders).
• \. History of systemic long-term medications (e.g., corticosteroids, immunosuppressants, anticoagulants, or NSAIDs).
• \. Known allergy or hypersensitivity to sesame oil, beeswax, beta-sitosterol, or any components of MEBO ointment.
• \. Severe periodontitis or active local oral infection/inflammation at the surgical site.
• \. Previous gingival depigmentation procedures performed at the target site within the past 12 months.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt

Location

Central Study Contacts

Maie Ismaiel, LECTURER

CONTACT

+201000020203; maie.ismaiel@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This trial employs a single-blind (assessor-blind) design. Due to the nature of topical ointment application, treating clinicians and participants cannot be blinded to the intervention. However, all in-clinic primary and secondary clinical evaluations (Landry Wound Healing Index, OHIP-14 questionnaire, and Gingival Color Match Score) are conducted by an independent, trained outcome assessor who is kept strictly blinded to the study group allocations throughout the entire 1-month evaluation period.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral medicine and periodontology, cairo university

Model Details: This is a 2 arms single-center, parallel-group, randomized controlled clinical trial with a 1:1 allocation ratio comparing two distinct post-operative protocols following rotary gingival depigmentation over a 1-month follow-up period. Eligible participants are randomly assigned to either Group A (MEBO bio-dressing applied topically 3 times daily for 7 days) or Group B (Control group with no dressing, left to heal by open secondary intention).

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available after publication of the main study findings in a peer-reviewed journal and will remain accessible for 3 years following publication.
• Access Criteria: Data will be shared with academic researchers who provide a methodologically sound research proposal. Requests should be directed to the Principal Investigator at Cairo University. A signed data use agreement will be required.

Locations

EG (1)