Gingival HyperpigmentationNCT07876921
MEBO Bio-Dressing on Patient-Reported Outcomes and Tissue Healing Following Rotary Gingival Depigmentation
A study testing MEBO Ointment in people with Gingival Hyperpigmentation and Oral Health-Related Quality of Life, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Gingival Hyperpigmentation, Oral Health-Related Quality of Life, Wound Healing
- What is being tested?
- MEBO Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate
Maie Ismaiel, lecturer, +201000020203, maie.ismaiel@dentistry.cu.edu.eg
About this study
Official title: Rethinking Postoperative Care In Esthetic Periodontics: Effect of MEBO Bio-Dressing on Patient-Reported Outcomes and Tissue Healing Following Rotary Gingival Depigmentation: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- MEBO Ointment
- Keywords
- gingival depigmentation, MEBO, bio-dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEBO OintmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Measured using a Visual Analogue Scale (VAS) score ranging from 0 (indicating no pain) to 10 (indicating worst imaginable unbearable pain).
Measured: 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.
Measured: Daily for 7 consecutive post-operative days
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline (Day 0) and Day 7 post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival HyperpigmentationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maie Esmaiel Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876921
- Sponsor's protocol ID
- CU-DENT-PERIO-MEBO-2026
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rethinking Postoperative Care In Esthetic Periodontics: Effect of MEBO Bio-Dressing on Patient-Reported Outcomes and Tissue Healing Following Rotary Gingival Depigmentation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07876921
- Acronym / sponsor ID
- CU-DENT-PERIO-MEBO-2026
- Keywords
- gingival depigmentation, MEBO, bio-dressing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| MEBO Bio-Dressing Group | Experimental | Drug: MEBO OintmentRotary gingival depigmentation using a polishing brush followed by topical application of MEBO ointment as a protective biological dressing 3 times daily for 7 days. |
| Control Group (Open Secondary Healing) | No intervention | –Rotary gingival depigmentation using a polishing brush followed by open secondary healing without any topical dressing application. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEBO OintmentTopical 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. | Drug | MEBO Bio-Dressing Group |
Primary outcome
Postoperative Pain Intensity
Time frame: 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
Time frame: 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.
2 secondary outcomes
Clinical Soft-Tissue Wound Healing
Time frame: Baseline (Day 0), and post-operatively at Days 3, 7, 14, 21, and 30
Oral Health-Related Quality of Life (OHIP-14)
Time frame: Baseline (Day 0) and Day 7 post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Gingival Hyperpigmentation
Enrolling by invitationPhase 3
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Recruiting
Vitamin C for Gingival Depigmentation
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Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEBO Ointment in people with Gingival Hyperpigmentation and Oral Health-Related Quality of Life, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maie Ismaiel, LECTURER (+201000020203, maie.ismaiel@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: Daily at 8:00 PM for 7 consecutive post-operative days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.