Gingival PigmentationDepigmentationNCT07410156
Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.
A study testing Gingival Depigmentation with Conventional Method, Gingival Depigmentation with Diode Laser and Gingival Depigmentation with Microneedling and Silymarin Application in people with Gingival Pigmentation and Gingival Hyperpigmentaion, run by Fayoum University at 1 site in Egypt.
Trial summary
The present study will be carried to evaluate the efficacy of MN technique with topical Silymarin application in treating gingival hyperpigmentation in comparison with Laser and scalpel methods. This evaluation will be done clinically. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Pigmentation, Gingival Hyperpigmentaion
- What is being tested?
- Gingival Depigmentation with Conventional Method, Gingival Depigmentation with Diode Laser and Gingival Depigmentation with Microneedling and Silymarin Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be free from any systemic diseases according to criteria of Modified Cornell Medical Index
- Patient with physiologic pigmentation
- Non smoker
- Patient agree to sign the written consent
- Both genders
Who cannot join
- Pregnant and lactating women
- Systemic conditions affect melanin production
- Medications induce pigmentation or enlargement
- Those with known allergies to silymarin.
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, 1 recruiting
- Recruiting
Fayoum University, Faculty of Dentistry, Department of Oral Medicine and Periodontology
Al Fayyum
Fayoum University. Fayoum 63514, 0842064056, odmed@fayoum.edu.eg
Nayroz Mohammed Tarrad, Professor
About this study
Official title: Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods. A Randomized Clinical Trial
The present study will be carried to evaluate the efficacy of MN technique with topical Silymarin application in treating gingival hyperpigmentation in comparison with Laser and scalpel methods. This evaluation will be done clinically. The questions to be answered:
- Is there a statistical difference between the microneedling (MN) technique with topical silymarin application, the scalpel technique, and the diode laser in providing clinical and aesthetic advantages in the treatment of gingival pigmentation?
- What medical problems do participants have when using of Silymarin topically?
Read more
Participants will be:
Group 1 : The gingiva of the facial surfaces of the selected area will be de-epithelized by conventional method through blades no 15c.
Group 2 : The gingiva of the facial surfaces of the selected area will be de-epithelized by A Diode laser Device (serolaser).
Group 3 : The gingiva of the facial surfaces of the selected area will be treated by repetitive punctures with Dr.Pen ULTIMA - A6 needle tip. Silymarin is applied topically for ten minutes.
- Conditions
- Gingival Pigmentation, Gingival Hyperpigmentaion
- Being tested
- Gingival Depigmentation with Conventional Method, Gingival Depigmentation with Diode Laser, Gingival Depigmentation with Microneedling and Silymarin Application
- Keywords
- Gingival depigmentation, Microneedling, Laser, Silymarin, Scalpel, Surgical depigmentation, Micro-needling, MN, Topical application, gingival hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival Depigmentation with Conventional MethodProcedure or surgery
Also called Scalpel depigmentation
Under aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be de-epithelized by using the blade till complete removal of the depigmented tissue reached method through blades no 15c till the entire pigmented area is resolved.
Gingival Depigmentation with Diode LaserProcedure or surgery
Also called Laser depigmentation
Under aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be de-epithelized by A Diode laser Device (serolaser) in a free running pulse mode. Remnants of the ablated tissue will be removed using sterile gauze dampened with saline. The procedure will be performed from a cervico-apical direction in all pigmented areas
Gingival Depigmentation with Microneedling and Silymarin ApplicationProcedure or surgery
Under aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be treated by repetitive punctures with Dr.Pen ULTIMA - A6 needle tip. The needle tip features six speed settings, ranging from 412 to 700 cycles per minute, with 12-24 needles arranged in rows. Healthcare professionals can treat areas in back and forth motion for 30- 40 seconds. Changing the needle length is simple with guides. Using the same handpiece for several patient applications is made possible by disposable needletips. Silymarin is applied topically for ten minutes.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Surgical method | Other | depigmentation done using scalpel blade NO15 c Receives: Procedure: Gingival Depigmentation with Conventional Method |
| Diode Laser | Active comparator | diode lase with wave length 980 and laser tip 320 micron Receives: Procedure: Gingival Depigmentation with Diode Laser |
| MN with Silymarin application | Active comparator | micro needling device Dr.Pen ULTIMA- M8 needle tip. The needle tip features six speed settings,ranging from 412 to 700 cycles per minute, with 12-24 needles arranged in rows. Healthcare professionals can treat areas in back and forth motion for 30 40 seconds. with topical application. Silymarin is applied topically for ten minutes at concentration 7mg/ml. Receives: Procedure: Gingival Depigmentation with Microneedling and Silymarin Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Pigmentation Recurrence
Visual assessment will be the way to measure how the gingiva is depigmented through DOPI score from 1 ( no pigments ) to 4 ( maximum pigments )
Measured: From the enrollment till 6 months
Secondary outcomes (1)
post-operative pain
VAS ( visual analogue scale ) from 0 ( no pain ) to 10 ( severe pain )
Measured: pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Gingival PigmentationStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Taha Amin Abdeltawab, Fayoum University
- Investigators
- Nayroz Mohammed Tarrad, Professor, Principal investigator, Oral Medicine and Periodontology Faculty of Dentistry, Fayoum UniversityRehab Ahmed Osman, Lecturer, Study director, Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410156
- Sponsor's protocol ID
- MN+Silymarin for depigmenation
- Acronym
- Depigmentation
- Status last verified
- May 2025
- First submitted
- 15 Nov 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalpidis CD, Lysitsa SN, Lombardi T, Kolokotronis AE, Antoniades DZ, Samson J. Gingival involvement in a case series of patients with acquired immunodeficiency syndrome-related Kaposi sarcoma. J Periodontol. 2006 Mar;77(3):523-33. doi: 10.1902/jop.2006.050226.
PubMed 16512768Javali, M., Tapashetti, R., & Deshmukh, J. (2011). Esthetic management of gingival hyperpigmentation: Report of two cases. International Journal of Dental Clinics, 3, 115-116.
Gupta S, Tandon A, Ram H, Gupta OP. Oral malignant melanoma: Report of three cases with literature review. Natl J Maxillofac Surg. 2015 Jan-Jun;6(1):103-9. doi: 10.4103/0975-5950.168239.
PubMed 26668465Huang LH, Neiva RE, Wang HL. Factors affecting the outcomes of coronally advanced flap root coverage procedure. J Periodontol. 2005 Oct;76(10):1729-34. doi: 10.1902/jop.2005.76.10.1729.
PubMed 16253095Fernandes D. Minimally invasive percutaneous collagen induction. Oral Maxillofac Surg Clin North Am. 2005 Feb;17(1):51-63, vi. doi: 10.1016/j.coms.2004.09.004.
PubMed 18088764Kren V, Walterova D. Silybin and silymarin--new effects and applications. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2005 Jun;149(1):29-41. doi: 10.5507/bp.2005.002.
PubMed 16170386Mashreghi Moghadam, P., Alavizadeh, S. H., Rasouli, S. R., Oskoueian, E., Momtazi-Borojeni, A. A., Kesharwani, P., Gheybi, F., Karimi, E., & Sahebkar, A. (2024). Adjuvant therapy with topical silymarin nanomicelles attenuates skin and hair depigmentation in a C57/BL6 mouse model of vitiligo.
Meleti M, Vescovi P, Mooi WJ, van der Waal I. Pigmented lesions of the oral mucosa and perioral tissues: a flow-chart for the diagnosis and some recommendations for the management. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 May;105(5):606-16. doi: 10.1016/j.tripleo.2007.07.047. Epub 2008 Feb 21.
PubMed 18206403Nagati, R., Ragul, M., Al-Qahtani, N., Ravi, K., Tikare, S., & Pasupuleti, M. (2017). Clinical effectiveness of gingival depigmentation using conventional surgical scraping and diode laser technique: A quasi- experimental study.
Roshna T, Nandakumar K. Anterior esthetic gingival depigmentation and crown lengthening: report of a case. J Contemp Dent Pract. 2005 Aug 15;6(3):139-47.
PubMed 16127483Singh RP, Agarwal R. Prostate cancer chemoprevention by silibinin: bench to bedside. Mol Carcinog. 2006 Jun;45(6):436-42. doi: 10.1002/mc.20223.
PubMed 16637061Yussif NM, Abdul Aziz MA, Abdel Rahman AR. Evaluation of the Anti-Inflammatory Effect of Locally Delivered Vitamin C in the Treatment of Persistent Gingival Inflammation: Clinical and Histopathological Study. J Nutr Metab. 2016;2016:2978741. doi: 10.1155/2016/2978741. Epub 2016 Dec 5.
PubMed 28050280Yussif, N. M. A., Zayed, S. O., Hasan, S. A., & Sadek, S. S. (2016). Evaluation of injectable vitamin C as a depigmenting agent in physiologic gingival melanin hyperpigmentation: A clinical trial.
Simanek, V., Skottova, N., Bartek, J., Psotova, J., Kosina, P., Balejova, L., & Ulrichova, J. (2001). Extract from Silybum marianum as a nutraceutical: a double-blind placebo-controlled study in healthy young men.
Sanjeevini, H., Pudakalkatti, P., Soumya, B., & Aarati, N. (2012). Gingival depigmentation: 2 case reports.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07410156
- Acronym / sponsor ID
- Depigmentation / MN+Silymarin for depigmenation
- Conditions
- Gingival Pigmentation, Gingival Hyperpigmentaion
- Keywords
- Gingival depigmentation, Microneedling, Laser, Silymarin, Scalpel, Surgical depigmentation, Micro-needling, MN
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 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.
The present study will be carried to evaluate the efficacy of MN technique with topical Silymarin application in treating gingival hyperpigmentation in comparison with Laser and scalpel methods. This evaluation will be done clinically. The questions to be answered:
- Is there a statistical difference between the microneedling (MN) technique with topical silymarin application, the scalpel technique, and the diode laser in providing clinical and aesthetic advantages in the treatment of gingival pigmentation?
- What medical problems do participants have when using of Silymarin topically?
Participants will be:
Group 1 : The gingiva of the facial surfaces of the selected area will be de-epithelized by conventional method through blades no 15c.
Group 2 : The gingiva of the facial surfaces of the selected area will be de-epithelized by A Diode laser Device (serolaser).
Group 3 : The gingiva of the facial surfaces of the selected area will be treated by repetitive punctures with Dr.Pen ULTIMA - A6 needle tip. Silymarin is applied topically for ten minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Surgical method | Other | Procedure: Gingival Depigmentation with Conventional Methoddepigmentation done using scalpel blade NO15 c |
| Diode Laser | Active comparator | Procedure: Gingival Depigmentation with Diode Laserdiode lase with wave length 980 and laser tip 320 micron |
| MN with Silymarin application | Active comparator | Procedure: Gingival Depigmentation with Microneedling and Silymarin Applicationmicro needling device Dr.Pen ULTIMA- M8 needle tip. The needle tip features six speed settings,ranging from 412 to 700 cycles per minute, with 12-24 needles arranged in rows. Healthcare professionals can treat areas in back and forth motion for 30 40 seconds. with topical application. Silymarin is applied topically for ten minutes at concentration 7mg/ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients will be free from any systemic diseases according to criteria of Modified Cornell Medical Index
- Patient with physiologic pigmentation
- Non smoker
- Patient agree to sign the written consent
- Both genders
Key exclusion criteria (4 listed)
- Pregnant and lactating women
- Systemic conditions affect melanin production
- Medications induce pigmentation or enlargement
- Those with known allergies to silymarin.
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 with Conventional MethodAlso: Scalpel depigmentationUnder aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be de-epithelized by using the blade till complete removal of the depigmented tissue reached method through blades no 15c till the entire pigmented area is resolved. | Procedure or surgery | Conventional Surgical method |
| Gingival Depigmentation with Diode LaserAlso: Laser depigmentationUnder aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be de-epithelized by A Diode laser Device (serolaser) in a free running pulse mode. Remnants of the ablated tissue will be removed using sterile gauze dampened with saline. The procedure will be performed from a cervico-apical direction in all pigmented areas | Procedure or surgery | Diode Laser |
| Gingival Depigmentation with Microneedling and Silymarin ApplicationUnder aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be treated by repetitive punctures with Dr.Pen ULTIMA - A6 needle tip. The needle tip features six speed settings, ranging from 412 to 700 cycles per minute, with 12-24 needles arranged in rows. Healthcare professionals can treat areas in back and forth motion for 30- 40 seconds. Changing the needle length is simple with guides. Using the same handpiece for several patient applications is made possible by disposable needletips. Silymarin is applied topically for ten minutes. | Procedure or surgery | MN with Silymarin application |
Primary outcome
Gingival Pigmentation Recurrence
Time frame: From the enrollment till 6 months
Visual assessment will be the way to measure how the gingiva is depigmented through DOPI score from 1 ( no pigments ) to 4 ( maximum pigments )
1 secondary outcome
post-operative pain
Time frame: pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week )
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 13 Feb 2026.
- Background: PubMed 16512768Kalpidis CD, Lysitsa SN, Lombardi T, Kolokotronis AE, Antoniades DZ, Samson J. Gingival involvement in a case series of patients with acquired immunodeficiency syndrome-related Kaposi sarcoma. J Periodontol. 2006 Mar;77(3):523-33. doi: 10.1902/jop.2006.050226.
- BackgroundJavali, M., Tapashetti, R., & Deshmukh, J. (2011). Esthetic management of gingival hyperpigmentation: Report of two cases. International Journal of Dental Clinics, 3, 115-116.
- Background: PubMed 26668465Gupta S, Tandon A, Ram H, Gupta OP. Oral malignant melanoma: Report of three cases with literature review. Natl J Maxillofac Surg. 2015 Jan-Jun;6(1):103-9. doi: 10.4103/0975-5950.168239.
- Background: PubMed 16253095Huang LH, Neiva RE, Wang HL. Factors affecting the outcomes of coronally advanced flap root coverage procedure. J Periodontol. 2005 Oct;76(10):1729-34. doi: 10.1902/jop.2005.76.10.1729.
- Background: PubMed 18088764Fernandes D. Minimally invasive percutaneous collagen induction. Oral Maxillofac Surg Clin North Am. 2005 Feb;17(1):51-63, vi. doi: 10.1016/j.coms.2004.09.004.
- Background: PubMed 16170386Kren V, Walterova D. Silybin and silymarin--new effects and applications. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2005 Jun;149(1):29-41. doi: 10.5507/bp.2005.002.
- BackgroundMashreghi Moghadam, P., Alavizadeh, S. H., Rasouli, S. R., Oskoueian, E., Momtazi-Borojeni, A. A., Kesharwani, P., Gheybi, F., Karimi, E., & Sahebkar, A. (2024). Adjuvant therapy with topical silymarin nanomicelles attenuates skin and hair depigmentation in a C57/BL6 mouse model of vitiligo.
- Background: PubMed 18206403Meleti M, Vescovi P, Mooi WJ, van der Waal I. Pigmented lesions of the oral mucosa and perioral tissues: a flow-chart for the diagnosis and some recommendations for the management. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 May;105(5):606-16. doi: 10.1016/j.tripleo.2007.07.047. Epub 2008 Feb 21.
- BackgroundNagati, R., Ragul, M., Al-Qahtani, N., Ravi, K., Tikare, S., & Pasupuleti, M. (2017). Clinical effectiveness of gingival depigmentation using conventional surgical scraping and diode laser technique: A quasi- experimental study.
- Background: PubMed 16127483Roshna T, Nandakumar K. Anterior esthetic gingival depigmentation and crown lengthening: report of a case. J Contemp Dent Pract. 2005 Aug 15;6(3):139-47.
- Background: PubMed 16637061Singh RP, Agarwal R. Prostate cancer chemoprevention by silibinin: bench to bedside. Mol Carcinog. 2006 Jun;45(6):436-42. doi: 10.1002/mc.20223.
- Background: PubMed 28050280Yussif NM, Abdul Aziz MA, Abdel Rahman AR. Evaluation of the Anti-Inflammatory Effect of Locally Delivered Vitamin C in the Treatment of Persistent Gingival Inflammation: Clinical and Histopathological Study. J Nutr Metab. 2016;2016:2978741. doi: 10.1155/2016/2978741. Epub 2016 Dec 5.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nayroz Mohammed Tarrad, Professor principal investigator
Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University
Rehab Ahmed Osman, Lecturer study director
Oral Medicine and Periodontology Faculty of Dentistry, Fayoum 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 with Conventional Method, Gingival Depigmentation with Diode Laser and Gingival Depigmentation with Microneedling and Silymarin Application in people with Gingival Pigmentation and Gingival Hyperpigmentaion, run by Fayoum 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 5 inclusion and 4 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 13 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 Tarek Taha TTAAbdeltawab, Researcher (+201100892663 ext. +201060406261, tt1139@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Pigmentation Recurrence (time frame: From the enrollment till 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07410156, which also lists 37 linked publications.
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 13 Feb 2026.