Gingival HyperpigmentationNCT07402720
Clinical Effectiveness Of Polishing Brush Compared To Ceramic Soft Tissue Trimming Bur In Gingival Depigmentation
A study testing Gingival Depigmentation using polishing brush and Depigmentation using ceramic soft tissue trimming bur in people with Gingival Hyperpigmentation, run by Cairo University at 1 site in Egypt.
Trial summary
Gingival hyperpigmentation, particularly of melanin origin, can pose significant aesthetic concerns, especially among patients with a high smile line. Several depigmentation techniques have been proposed to manage this condition, including scalpel surgery, electrosurgery, cryotherapy, lasers, and various rotary… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Gingival Hyperpigmentation
- What is being tested?
- Gingival Depigmentation using polishing brush and Depigmentation using ceramic soft tissue trimming bur
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to Mar 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of melanin hyperpigmentation (Dummett Oral Pigmentation Index ≥ 2)
- Presence of bilateral gingival pigmentation extending at least 3 teeth in each arch
- Age range: e.g., 18-40 years (adjust based on your sample)
- Non-smokers (or smokers <10 cigarettes/day, specify if allowed)
- Systemically healthy
- Willingness to participate and sign informed consent 8
- Available for follow-up appointments
- No previous periodontal surgery in the area other than prophylaxis
Who cannot join
- • Systemic conditions affecting healing (e.g., diabetes mellitus,immunosuppressive disorders)
- Pregnant or lactating women
- Heavy Smokers
- Ongoing orthodontic treatment in the affected area
- Use of medications affecting gingiva (e.g., phenytoin, cyclosporine, calcium channel blockers)
- Poor oral hygiene at baseline
Show all 10Show fewer
- Active periodontal pockets >3 mm or clinical attachment loss
- Allergy to local anesthetics or materials used in the procedure
- History of alcohol or drug abuse
- Psychological conditions that may interfere with compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Effectiveness Of Polishing Brush Compared to Ceramic Soft Tissue Trimming Bur In Gingival Depigmentation: A Randomized Controlled Trial
Gingival hyperpigmentation, particularly of melanin origin, can pose significant aesthetic concerns, especially among patients with a high smile line. Several depigmentation techniques have been proposed to manage this condition, including scalpel surgery, electrosurgery, cryotherapy, lasers, and various rotary instruments. Recently, minimally invasive rotary tools such as ceramic burs and polishing brushes have gained interest due to their potential to deliver controlled ablation with reduced postoperative discomfort and healing complications.
Ceramic soft tissue trimming burs are specially designed to remove superficial pigmented gingival layers with minimal trauma. However, these instruments may still generate heat and cause a degree of tissue damage. On the other hand, polishing brushes, traditionally used for surface finishing and stain removal, have recently been explored for soft tissue applications due to their gentle action and adaptability.
Despite their increasing use, there is insufficient comparative clinical evidence on the efficacy, healing outcomes, and patient-centered experiences between these two modalities in gingival depigmentation. A split-mouth randomized controlled trial design offers the advantage of eliminating inter-individual variability. Thus, this study aims to assess and compare the clinical effectiveness of the polishing brush and ceramic trimming bur for gingival depigmentation in terms of pigment reduction, healing outcomes, postoperative pain, and recurrence.
Read the detailed description
This study is designed as a prospective randomized controlled clinical trial with a parallel intraoral comparison between two treatment modalities:
- Depigmentation using polishing brush and
- Depigmentation using ceramic soft tissue trimming bur. Participants will be randomly allocated into two independent groups, with each group receiving one of the two interventions on both sides of the arch. This parallel design ensures that each participant receives only one treatment modality, thereby preventing any crossover effects and allowing for between-subject comparison. Randomization will be conducted using a computergenerated sequence to ensure unbiased allocation. Blinding of the outcome assessor will be maintained to minimize assessment bias.
The trial will adhere to CONSORT guidelines, with baseline data collection followed by standardized clinical evaluations at predefined follow-up intervals to assess changes in gingival thickness and other relevant soft tissue parameters.
The study will be conducted at the Department of Oral Medicine and Periodontology, Faculty of Dentistry - Cairo University, Egypt.
Participants will be recruited from the outpatient clinic of the same department.
Population:
Systemically healthy patients with gingival hyperpigmentation.
Intervention:
Depigmentation using a polishing brush.
Comparison:
Depigmentation using ceramic soft tissue trimming bur.
Treatment:
Healthy, nonsmokers with moderate to severe gingival hyperpigmentation in both arches will be assigned for Polishing Brush Compared To Ceramic Soft Tissue Trimming Bur • Study Groups:
- Group 1: Depigmentation using polishing brush
- Group 2: Depigmentation using ceramic soft tissue trimming bur
Preoperative evaluation:
- Clinical examination: A comprehensive clinical examination of the patient's oral cavity and periodontal condition will be performed to assess baseline oral health. This will be complemented by a structured oral interview aimed at evaluating the patient's adherence to the study's inclusion criteria, with a particular focus on oral hygiene practices, habits and overall compliance.
Polishing brush In the test group, gingival depigmentation will be performed using a polishing brush specifically adapted for soft tissue application.
After administering local anesthesia, a silicon carbide or rubber-based polishing brush will be attached to a low-speed handpiece. The pigmented gingival epithelium will be gently abraded in a circular motion under light pressure until the superficial pigmented layer is removed and uniform pink gingiva is visible. Continuous irrigation with sterile saline will be used to prevent heat generation and ensure visibility. The operator will take care not to injure the underlying connective tissue. No periodontal dressing will be applied. Postoperative instructions will include gentle oral hygiene, avoiding hot or spicy foods, and use of 0.12% chlorhexidine mouthwash for 1 week.
Ceramic bur In the control group, ceramic soft tissue trimming burs will be used to perform gingival depigmentation. After achieving local anesthesia, a flame- or round-shaped ceramic bur will be attached to a low-speed contra-angle handpiece. The bur will be used in a brushing motion to carefully remove the pigmented epithelial layer without applying excessive pressure. The clinician will maintain light, controlled strokes to avoid damaging the underlying lamina propria. As with the polishing brush technique, continuous irrigation with saline will be provided to cool the tissue and improve visibility. Once the pigmented areas are cleared and a healthy pink gingival color is achieved, the procedure will be concluded without any periodontal dressing. Postoperative care will follow the same protocol as the polishing brush group.
Patient-Reported Outcomes:
Oral health-related quality of life (OHRQoL) will be assessed using the validated Oral Health Impact Profile (OHIP-14) questionnaire, which measures the functional, psychological, and social impacts of oral conditions on everyday life. The OHIP-14 consists of 14 items covering seven conceptual domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Participants will complete the OHIP-14 at baseline and again three months post-treatment to assess changes in self-perceived oral health status and quality of life. Incorporating this patient-reported outcome measure enables a comprehensive evaluation of treatment effectiveness beyond clinical indicators alone.
Postoperative instructions and follow up:
All patients will receive standardized postoperative care instructions immediately following the depigmentation procedure. Patients will be advised to avoid trauma or mechanical irritation to the treated area for at least 1-2 weeks. Toothbrushing in the surgical sites will be restricted to the use of an ultrasoft toothbrush, and gentle brushing techniques will be demonstrated. The use of chemical plaque control agents such as 0.12% chlorhexidine mouthwash will be prescribed twice daily for 1-2 weeks to aid plaque control and reduce the risk of postoperative infection.
Patients will be instructed to refrain from consuming hot, spicy, or abrasive foods for the first few days to minimize discomfort and irritation. Analgesics will be prescribed as needed for pain management, according to individual patient tolerance and medical history.
Postoperative Follow-Up :
Patients will be recalled for clinical evaluation at 1 week, 2 weeks, 1 month, and 3 months postoperatively. At each follow-up visit, the surgical sites will be examined for signs of healing, presence of infection, inflammation, or any adverse tissue reactions. Re-epithelialization, color match with surrounding gingiva, patient comfort, and recurrence of pigmentation will be assessed and documented.
Professional plaque control will be reinforced at each visit, and oral hygiene instructions will be reiterated as necessary. Any complications or patient-reported concerns will be addressed promptly.
If re-pigmentation is noted during the follow-up period, its extent and pattern will be recorded for further analysis. Digital photographs may be taken at baseline and each follow-up visit to monitor healing and pigmentation changes objectively.
- Conditions
- Gingival Hyperpigmentation
- Being tested
- Gingival Depigmentation using polishing brush, Depigmentation using ceramic soft tissue trimming bur
- Keywords
- ceramic bur, polishing brush, gingival hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival Depigmentation using polishing brushProcedure or surgery
gingival depigmentation will be performed using a polishing brush specifically adapted for soft tissue application. After administering local anesthesia, a silicon carbide or rubber-based polishing brush will be attached to a low-speed handpiece. The pigmented gingival epithelium will be gently abraded in a circular motion under light pressure until the superficial pigmented layer is removed and uniform pink gingiva is visible. Continuous irrigation with sterile saline will be used to prevent heat generation and ensure visibility. The operator will take care not to injure the underlying connective tissue. No periodontal dressing will be applied. Postoperative instructions will include gentle oral hygiene, avoiding hot or spicy foods, and use of 0.12% chlorhexidine mouthwash for 1 week.
Depigmentation using ceramic soft tissue trimming burProcedure or surgery
ceramic soft tissue trimming burs will be used to perform gingival depigmentation. After achieving local anesthesia, a flame- or round-shaped ceramic bur will be attached to a low-speed contra-angle handpiece. The bur will be used in a brushing motion to carefully remove the pigmented epithelial layer without applying excessive pressure. The clinician will maintain light, controlled strokes to avoid damaging the underlying lamina propria. As with the polishing brush technique, continuous irrigation with saline will be provided to cool the tissue and improve visibility. Once the pigmented areas are cleared and a healthy pink gingival color is achieved, the procedure will be concluded without any periodontal dressing. Postoperative care will follow the same protocol as the polishing brush group.
| Study group | Role | What they receive |
|---|---|---|
| Polishing brush | Active comparator | In the test group, gingival depigmentation will be performed using a polishing brush specifically adapted for soft tissue application. After administering local anesthesia, a silicon carbide or rubber-based polishing brush will be attached to a low-speed handpiece. The pigmented gingival epithelium will be gently abraded in a circular motion under light pressure until the superficial pigmented layer is removed and uniform pink gingiva is visible. Continuous irrigation with sterile saline will be used to prevent heat generation and ensure visibility. The operator will take care not to injure the underlying connective tissue. No periodontal dressing will be applied. Postoperative instructions will include gentle oral hygiene, avoiding hot or spicy foods, and use of 0.12% chlorhexidine mouthwash for 1 week. Receives: Procedure: Gingival Depigmentation using polishing brush |
| Ceramic bur | Experimental | In the control group, ceramic soft tissue trimming burs will be used to perform gingival depigmentation. After achieving local anesthesia, a flame- or round-shaped ceramic bur will be attached to a low-speed contra-angle handpiece. The bur will be used in a brushing motion to carefully remove the pigmented epithelial layer without applying excessive pressure. The clinician will maintain light, controlled strokes to avoid damaging the underlying lamina propria. As with the polishing brush technique, continuous irrigation with saline will be provided to cool the tissue and improve visibility. Once the pigmented areas are cleared and a healthy pink gingival color is achieved, the procedure will be concluded without any periodontal dressing. Postoperative care will follow the same protocol as the polishing brush group. Receives: Procedure: Depigmentation using ceramic soft tissue trimming bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival pigmentation intensity
Dummett Oral Pigmentation Index (DOPI). This is an ordinal index that categorizes pigmentation on a 4-point scale: 0 = no pigmentation, 1 = mild, 2 = moderate, and 3 = heavy pigmentation.
Measured: Baseline, 1 Week, 1 month and at 3 months
Secondary outcomes (6)
Patient Satisfaction
Evaluated using a Visual Analog Score based questionnaire reflecting the Oral Health Related Quality of Life (OHRQoL), adapted from OHIP-1 to OHIP-14, measuring satisfaction with esthetic and functional outcomes following treatment. containing seven first-order factors (dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap) This instrument has a 5-point Likert-type response scale (0: never, 1: hardly ever, 2: occasionally, 3: fairly often, 4: very often).
Measured: At Baseline, and at 3 months.
Operating Time
Measured in minutes using a digital stopwatch from the start of the depigmentation procedure until the end of hemostasis and final inspection.
Measured: Perioperative. From the start of the depigmentation procedure until the end of hemostasis and final inspection.
Pain Perception
Assessed using a Visual Analog Scale (VAS), where participants will rate their pain perception on a continuous scale from 0 (no pain) to 10 (worst imaginable pain).
Measured: Day 1, Day 3, 1 week, Day 10
Extent of Pigmentation
Assessed using the Takashi Index, a 3-grade ordinal scale scoring the extent of pigmentation as follows:0 = no pigmentation, 1 = isolated spots, and 2 = continuous ribbon. This will be recorded at each time point to assess reduction in pigmentation area.
Measured: Baseline, 1 Week, 1 month and at 3 months
Wound Healing
Evaluated using the Healing Index of Landry, Turnbull, and Howley (1988), a 5-point scale ranging from 1 (very poor) to 5 (excellent), based on clinical observations of tissue color, bleeding, granulation, and epithelialization.
Measured: 1 week, 3 months
Recurrence Rate
Measured using the Melanin Pigmentation Index (MPI) at 1 week, 1 month, and 3 months postoperatively, scored as 0 = no pigmentation and 1 = presence of pigmentation.
Measured: 1 week, 1 month, and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghad hisham, Cairo University
- Investigators
- Mona Darhous, Professor, Study director, Cairo UniveristyMaie Esmaiel, Lecturer, Study chair, Cairo UniversityRaghad Hamadh, Bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402720
- Sponsor's protocol ID
- 2026PER3-3-1
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness Of Polishing Brush Compared to Ceramic Soft Tissue Trimming Bur In Gingival Depigmentation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07402720
- Acronym / sponsor ID
- 2026PER3-3-1
- Conditions
- Gingival Hyperpigmentation
- Keywords
- ceramic bur, polishing brush, gingival hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 Feb 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.
Gingival hyperpigmentation, particularly of melanin origin, can pose significant aesthetic concerns, especially among patients with a high smile line. Several depigmentation techniques have been proposed to manage this condition, including scalpel surgery, electrosurgery, cryotherapy, lasers, and various rotary instruments. Recently, minimally invasive rotary tools such as ceramic burs and polishing brushes have gained interest due to their potential to deliver controlled ablation with reduced postoperative discomfort and healing complications.
Ceramic soft tissue trimming burs are specially designed to remove superficial pigmented gingival layers with minimal trauma. However, these instruments may still generate heat and cause a degree of tissue damage. On the other hand, polishing brushes, traditionally used for surface finishing and stain removal, have recently been explored for soft tissue applications due to their gentle action and adaptability.
Despite their increasing use, there is insufficient comparative clinical evidence on the efficacy, healing outcomes, and patient-centered experiences between these two modalities in gingival depigmentation. A split-mouth randomized controlled trial design offers the advantage of eliminating inter-individual variability. Thus, this study aims to assess and compare the clinical effectiveness of the polishing brush and ceramic trimming bur for gingival depigmentation in terms of pigment reduction, healing outcomes, postoperative pain, and recurrence.
Detailed description
This study is designed as a prospective randomized controlled clinical trial with a parallel intraoral comparison between two treatment modalities:
- Depigmentation using polishing brush and
- Depigmentation using ceramic soft tissue trimming bur. Participants will be randomly allocated into two independent groups, with each group receiving one of the two interventions on both sides of the arch. This parallel design ensures that each participant receives only one treatment modality, thereby preventing any crossover effects and allowing for between-subject comparison. Randomization will be conducted using a computergenerated sequence to ensure unbiased allocation. Blinding of the outcome assessor will be maintained to minimize assessment bias.
The trial will adhere to CONSORT guidelines, with baseline data collection followed by standardized clinical evaluations at predefined follow-up intervals to assess changes in gingival thickness and other relevant soft tissue parameters.
The study will be conducted at the Department of Oral Medicine and Periodontology, Faculty of Dentistry - Cairo University, Egypt.
Participants will be recruited from the outpatient clinic of the same department.
Population:
Systemically healthy patients with gingival hyperpigmentation.
Intervention:
Depigmentation using a polishing brush.
Comparison:
Depigmentation using ceramic soft tissue trimming bur.
Treatment:
Healthy, nonsmokers with moderate to severe gingival hyperpigmentation in both arches will be assigned for Polishing Brush Compared To Ceramic Soft Tissue Trimming Bur • Study Groups:
- Group 1: Depigmentation using polishing brush
- Group 2: Depigmentation using ceramic soft tissue trimming bur
Preoperative evaluation:
- Clinical examination: A comprehensive clinical examination of the patient's oral cavity and periodontal condition will be performed to assess baseline oral health. This will be complemented by a structured oral interview aimed at evaluating the patient's adherence to the study's inclusion criteria, with a particular focus on oral hygiene practices, habits and overall compliance.
Polishing brush In the test group, gingival depigmentation will be performed using a polishing brush specifically adapted for soft tissue application.
After administering local anesthesia, a silicon carbide or rubber-based polishing brush will be attached to a low-speed handpiece. The pigmented gingival epithelium will be gently abraded in a circular motion under light pressure until the superficial pigmented layer is removed and uniform pink gingiva is visible. Continuous irrigation with sterile saline will be used to prevent heat generation and ensure visibility. The operator will take care not to injure the underlying connective tissue. No periodontal dressing will be applied. Postoperative instructions will include gentle oral hygiene, avoiding hot or spicy foods, and use of 0.12% chlorhexidine mouthwash for 1 week.
Ceramic bur In the control group, ceramic soft tissue trimming burs will be used to perform gingival depigmentation. After achieving local anesthesia, a flame- or round-shaped ceramic bur will be attached to a low-speed contra-angle handpiece. The bur will be used in a brushing motion to carefully remove the pigmented epithelial layer without applying excessive pressure. The clinician will maintain light, controlled strokes to avoid damaging the underlying lamina propria. As with the polishing brush technique, continuous irrigation with saline will be provided to cool the tissue and improve visibility. Once the pigmented areas are cleared and a healthy pink gingival color is achieved, the procedure will be concluded without any periodontal dressing. Postoperative care will follow the same protocol as the polishing brush group.
Patient-Reported Outcomes:
Oral health-related quality of life (OHRQoL) will be assessed using the validated Oral Health Impact Profile (OHIP-14) questionnaire, which measures the functional, psychological, and social impacts of oral conditions on everyday life. The OHIP-14 consists of 14 items covering seven conceptual domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Participants will complete the OHIP-14 at baseline and again three months post-treatment to assess changes in self-perceived oral health status and quality of life. Incorporating this patient-reported outcome measure enables a comprehensive evaluation of treatment effectiveness beyond clinical indicators alone.
Postoperative instructions and follow up:
All patients will receive standardized postoperative care instructions immediately following the depigmentation procedure. Patients will be advised to avoid trauma or mechanical irritation to the treated area for at least 1-2 weeks. Toothbrushing in the surgical sites will be restricted to the use of an ultrasoft toothbrush, and gentle brushing techniques will be demonstrated. The use of chemical plaque control agents such as 0.12% chlorhexidine mouthwash will be prescribed twice daily for 1-2 weeks to aid plaque control and reduce the risk of postoperative infection.
Patients will be instructed to refrain from consuming hot, spicy, or abrasive foods for the first few days to minimize discomfort and irritation. Analgesics will be prescribed as needed for pain management, according to individual patient tolerance and medical history.
Postoperative Follow-Up :
Patients will be recalled for clinical evaluation at 1 week, 2 weeks, 1 month, and 3 months postoperatively. At each follow-up visit, the surgical sites will be examined for signs of healing, presence of infection, inflammation, or any adverse tissue reactions. Re-epithelialization, color match with surrounding gingiva, patient comfort, and recurrence of pigmentation will be assessed and documented.
Professional plaque control will be reinforced at each visit, and oral hygiene instructions will be reiterated as necessary. Any complications or patient-reported concerns will be addressed promptly.
If re-pigmentation is noted during the follow-up period, its extent and pattern will be recorded for further analysis. Digital photographs may be taken at baseline and each follow-up visit to monitor healing and pigmentation changes objectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polishing brush | Active comparator | Procedure: Gingival Depigmentation using polishing brushIn the test group, gingival depigmentation will be performed using a polishing brush specifically adapted for soft tissue application. After administering local anesthesia, a silicon carbide or rubber-based polishing brush will be attached to a low-speed handpiece. The pigmented gingival epithelium will be gently abraded in a circular motion under light pressure until the superficial pigmented layer is removed and uniform pink gingiva is visible. Continuous irrigation with sterile saline will be used to prevent heat generation and ensure visibility. The operator will take care not to injure the underlying connective tissue. No periodontal dressing will be applied. Postoperative instructions will include gentle oral hygiene, avoiding hot or spicy foods, and use of 0.12% chlorhexidine mouthwash for 1 week. |
| Ceramic bur | Experimental | Procedure: Depigmentation using ceramic soft tissue trimming burIn the control group, ceramic soft tissue trimming burs will be used to perform gingival depigmentation. After achieving local anesthesia, a flame- or round-shaped ceramic bur will be attached to a low-speed contra-angle handpiece. The bur will be used in a brushing motion to carefully remove the pigmented epithelial layer without applying excessive pressure. The clinician will maintain light, controlled strokes to avoid damaging the underlying lamina propria. As with the polishing brush technique, continuous irrigation with saline will be provided to cool the tissue and improve visibility. Once the pigmented areas are cleared and a healthy pink gingival color is achieved, the procedure will be concluded without any periodontal dressing. Postoperative care will follow the same protocol as the polishing brush group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Presence of melanin hyperpigmentation (Dummett Oral Pigmentation Index ≥ 2)
- Presence of bilateral gingival pigmentation extending at least 3 teeth in each arch
- Age range: e.g., 18-40 years (adjust based on your sample)
- Non-smokers (or smokers <10 cigarettes/day, specify if allowed)
- Systemically healthy
Key exclusion criteria (10 listed)
- • Systemic conditions affecting healing (e.g., diabetes mellitus,immunosuppressive disorders)
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 |
|---|---|---|
| Gingival Depigmentation using polishing brushgingival depigmentation will be performed using a polishing brush specifically adapted for soft tissue application. After administering local anesthesia, a silicon carbide or rubber-based polishing brush will be attached to a low-speed handpiece. The pigmented gingival epithelium will be gently abraded in a circular motion under light pressure until the superficial pigmented layer is removed and uniform pink gingiva is visible. Continuous irrigation with sterile saline will be used to prevent heat generation and ensure visibility. The operator will take care not to injure the underlying connective tissue. No periodontal dressing will be applied. Postoperative instructions will include gentle oral hygiene, avoiding hot or spicy foods, and use of 0.12% chlorhexidine mouthwash for 1 week. | Procedure or surgery | Polishing brush |
| Depigmentation using ceramic soft tissue trimming burceramic soft tissue trimming burs will be used to perform gingival depigmentation. After achieving local anesthesia, a flame- or round-shaped ceramic bur will be attached to a low-speed contra-angle handpiece. The bur will be used in a brushing motion to carefully remove the pigmented epithelial layer without applying excessive pressure. The clinician will maintain light, controlled strokes to avoid damaging the underlying lamina propria. As with the polishing brush technique, continuous irrigation with saline will be provided to cool the tissue and improve visibility. Once the pigmented areas are cleared and a healthy pink gingival color is achieved, the procedure will be concluded without any periodontal dressing. Postoperative care will follow the same protocol as the polishing brush group. | Procedure or surgery | Ceramic bur |
Primary outcome
gingival pigmentation intensity
Time frame: Baseline, 1 Week, 1 month and at 3 months
Dummett Oral Pigmentation Index (DOPI). This is an ordinal index that categorizes pigmentation on a 4-point scale: 0 = no pigmentation, 1 = mild, 2 = moderate, and 3 = heavy pigmentation.
6 secondary outcomes
Patient Satisfaction
Time frame: At Baseline, and at 3 months.
Operating Time
Time frame: Perioperative. From the start of the depigmentation procedure until the end of hemostasis and final inspection.
Pain Perception
Time frame: Day 1, Day 3, 1 week, Day 10
Extent of Pigmentation
Time frame: Baseline, 1 Week, 1 month and at 3 months
Wound Healing
Time frame: 1 week, 3 months
Recurrence Rate
Time frame: 1 week, 1 month, and 3 months.
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 12 Feb 2026.
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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.
Mona Darhous, Professor study director
Cairo Univeristy
Maie Esmaiel, Lecturer study chair
Cairo University
Raghad Hamadh, Bachelor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival Depigmentation using polishing brush and Depigmentation using ceramic soft tissue trimming bur in people with Gingival Hyperpigmentation, 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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Feb 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 Raghad Hamadh, Bachelor (+201016602933, raghad.hisham@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingival pigmentation intensity (time frame: Baseline, 1 Week, 1 month and at 3 months). 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 12 Feb 2026.