Gingival Hyperpigmentation, Oral Health-Related Quality of Life, Wound Healing
Conditions
Keywords
gingival depigmentation, MEBO, bio-dressing
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.
Detailed description
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.
Interventions
DRUGMEBO Ointment
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Systemically healthy adult patients aged 18 to 50 years. * Presence of bilateral, symmetrical physiological gingival hyperpigmentation (Dummett Oral Pigmentation Index score \>= 2) requiring esthetic treatment. * Good oral hygiene status (Plaque Index \<= 1).= 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.
Exclusion criteria
* Smokers or patients using any form of tobacco/nicotine products. * Pregnant, lactating, or planning pregnancy during the trial period. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | Daily at 8:00 PM for 7 consecutive post-operative days | Measured using a Visual Analogue Scale (VAS) score ranging from 0 (indicating no pain) to 10 (indicating worst imaginable unbearable pain). |
| Total Rescue Analgesic Consumption | Daily for 7 consecutive post-operative days | Cumulative number and total dosage in milligrams of Ibuprofen 600 mg tablets consumed by the participant for post-operative pain control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Soft-Tissue Wound Healing | Baseline (Day 0), and post-operatively at Days 3, 7, 14, 21, and 30 | 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). |
| Oral Health-Related Quality of Life (OHIP-14) | Baseline (Day 0) and Day 7 post-operatively | 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. |
Countries
Egypt
Contacts
CONTACTMaie Ismaiel, LECTURER
Outcome results
None listed