An interventional study of MEBO Ointment in Gingival Hyperpigmentation, Oral Health-Related Quality of Life and Wound Healing, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Cairo University · Not applicable, Interventional, and Supportive care
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.
Gingival hyperpigmentation is a common esthetic concern characterized by excessive melanin deposition in the basal and suprabasal layers of the oral epithelium. While rotary depigmentation using a polishing brush provides a controlled, superficial de-epithelialization method, the resulting open connective tissue wound heals by secondary intention, often causing postoperative pain and discomfort during daily activities.
Moist Exposed Burn Ointment (MEBO) is a natural lipid-based topical formulation containing beta-sitosterol, sesame oil, and beeswax that provides a moist biological microenvironment to promote rapid re-epithelialization and wound healing. While split-mouth designs carry a high risk of cross-contamination across the midline due to salivary flow, this trial utilizes a parallel-group design to deliver unconfounded evidence regarding postoperative outcomes.
Eligible systemically healthy adult participants presenting with bilateral, symmetrical physiological gingival hyperpigmentation will undergo standardized rotary de-epithelialization using a stiff polishing brush under local anesthesia. Following hemostasis, participants will be randomly allocated (1:1 ratio) into one of two groups:
Intervention Group (MEBO Dressing): MEBO ointment is applied immediately postoperatively and re-applied topically by the patient 3 times daily for 7 days.
Control Group (No Dressing): Rinsed thoroughly with sterile saline and left uncovered to heal by open secondary intention.
Postoperative pain (Visual Analogue Scale) and rescue analgesic consumption (Ibuprofen 600 mg) will be recorded daily for 7 days using standardized daily diaries. In-clinic follow-up evaluations will be performed at Days 3, 7, 14, 21, and 30 by a blinded examiner to assess clinical soft-tissue wound healing (Landry, Turnbull, and Rosenberg Healing Index), Oral Health-Related Quality of Life (OHIP-14), and gingival color match.
Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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
Rotary gingival depigmentation using a polishing brush followed by open secondary healing without any topical dressing application.
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.
Postoperative Pain Intensity
Measured using a Visual Analogue Scale (VAS) score ranging from 0 (indicating no pain) to 10 (indicating worst imaginable unbearable pain).
Time frame: 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.
Time frame: Daily for 7 consecutive post-operative days
Clinical Soft-Tissue Wound Healing
Evaluated using the Landry, Turnbull, and Rosenberg Healing Index based on tissue color, bleeding on palpation, presence of granulation tissue, tissue response, and epithelial coverage (scores ranging from 1 = very poor to 5 = excellent).
Time frame: Baseline (Day 0), and post-operatively at Days 3, 7, 14, 21, and 30
Oral Health-Related Quality of Life (OHIP-14)
Assessed using the validated Oral Health Impact Profile-14 (OHIP-14) questionnaire measuring functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.
Time frame: Baseline (Day 0) and Day 7 post-operatively
Gingival Color Match Score
Evaluated clinically by a blinded assessor comparing the healed treated area to the adjacent non-pigmented normal tissue to rate esthetic harmony.
Time frame: Day 14 and Day 30 post-operatively
Plan to share: Yes — De-identified individual participant data collected during the trial (including VAS pain scores, daily analgesic consumption, Landry wound healing scores, and OHIP-14 data) will be made available upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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