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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Tarek Taha TTAAbdeltawab, Researcher contact

+201100892663 ext. +201060406261

tt1139@fayoum.edu.eg

Rehab Ahmed Osman, Lecturer contact

+201096992996 ext. +201153832971

rau11@fayoum.edu.eg

Egypt1 site, 1 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

    Recruiting

Other trials in Egypt

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.

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 groups in NCT07410156
Study groupRoleWhat they receive
Conventional Surgical methodOtherdepigmentation done using scalpel blade NO15 c
Receives: Procedure: Gingival Depigmentation with Conventional Method
Diode LaserActive comparatordiode lase with wave length 980 and laser tip 320 micron
Receives: Procedure: Gingival Depigmentation with Diode Laser
MN with Silymarin applicationActive comparatormicro 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.

  1. 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)
  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.

  1. First posted13 Feb 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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)
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 16512768
  • Javali, 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 26668465
  • Huang 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 16253095
  • Fernandes 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 18088764
  • Kren 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 16170386
  • Mashreghi 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 18206403
  • Nagati, 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 16127483
  • Singh 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 16637061
  • Yussif 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 28050280
  • Yussif, 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.

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.

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