Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.

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

Overview

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.

Interventions

• Procedure Gingival Depigmentation with Conventional Method
  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.
• Procedure Gingival Depigmentation with Diode Laser
  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
• Procedure Gingival Depigmentation with Microneedling and Silymarin Application
  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 applicat

Primary outcome measures

• Gingival Pigmentation Recurrence [Time frame: From the enrollment till 6 months]

Secondary outcome measures (1)

• post-operative pain [Time frame: pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week )]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• Pregnant and lactating women
• Systemic conditions affect melanin production
• Medications induce pigmentation or enlargement
• Those with known allergies to silymarin.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Fayoum University, Faculty of Dentistry, Department of Oral Medicine and Periodontology — Al Fayyum

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 18206403

Identifiers

NCT: NCT07410156 · MN+Silymarin for depigmenation

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗