Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:31 PM
Study NCT ID:
NCT07410156
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2025-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054023', 'term': 'Lasers, Semiconductor'}, {'id': 'D000097244', 'term': 'Percutaneous Collagen Induction'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking Description'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-07', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2026-02-07', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Wound Healing', 'timeFrame': 'wound healing will recorded at 7,14,30 days postoperative ( from enrollment till 4 weeks )', 'description': 'Wound healing index Score 1 : Uneventful healing with no gingival oedema, erythema, suppuration, patient discomfort, or flap dehiscence Score 2 : Uneventful healing with slight gingival oedema, erythema, patient discomfort, or flap dehiscence, but no suppuration Score 3 : Poor wound healing with significant gingival oedema, erythema, patient discomfort, flap dehiscence, or any suppuration'}], 'primaryOutcomes': [{'measure': 'Gingival Pigmentation Recurrence', 'timeFrame': 'From the enrollment till 6 months', 'description': 'Visual assessment will be the way to measure how the gingiva is depigmented through DOPI score from 1 ( no pigments ) to 4 ( maximum pigments )'}], 'secondaryOutcomes': [{'measure': 'post-operative pain', 'timeFrame': 'pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week )', 'description': 'VAS ( visual analogue scale ) from 0 ( no pain ) to 10 ( severe pain )'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival depigmentation', 'Microneedling', 'Laser', 'Silymarin', 'Scalpel', 'Surgical depigmentation', 'Micro-needling', 'MN', 'Topical application', 'gingival hyperpigmentation'], 'conditions': ['Gingival Pigmentation', 'Gingival Hyperpigmentaion']}, 'referencesModule': {'references': [{'pmid': '16512768', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Javali, M., Tapashetti, R., & Deshmukh, J. (2011). Esthetic management of gingival hyperpigmentation: Report of two cases. International Journal of Dental Clinics, 3, 115-116.'}, {'pmid': '26668465', 'type': 'BACKGROUND', 'citation': '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': '16253095', 'type': 'BACKGROUND', 'citation': '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': '18088764', 'type': 'BACKGROUND', 'citation': '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': '16170386', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18206403', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16127483', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16637061', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28050280', 'type': 'BACKGROUND', 'citation': 'Yussif NM, Abdul Aziz MA, Abdel Rahman AR. 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Gingival depigmentation: A case report.'}, {'type': 'BACKGROUND', 'citation': 'Prabhuji, M., Madhupreetha, S., & Archana, V. (2011). Treatment of gingival hyperpigmentation for aesthetic purposes using the diode laser.'}, {'pmid': '38752063', 'type': 'BACKGROUND', 'citation': 'P SM, S S. Comparative Assessment of Gingival Depigmentation Using Scalpel Versus Microneedling With Ascorbic Acid: A Randomized Controlled Trial. Cureus. 2024 Apr 15;16(4):e58285. doi: 10.7759/cureus.58285. eCollection 2024 Apr.'}, {'pmid': '37153928', 'type': 'BACKGROUND', 'citation': 'Pasupuleti MK, Nagate RR, Alqahtani SM, Penmetsa GS, Gottumukkala SNVS, Ramesh KSV. Role of Medicinal Herbs in Periodontal Therapy: A Systematic Review. J Int Soc Prev Community Dent. 2023 Feb 27;13(1):9-16. doi: 10.4103/jispcd.JISPCD_210_22. eCollection 2023 Jan-Feb.'}, {'pmid': '7555659', 'type': 'BACKGROUND', 'citation': 'Riederer J. [Value of the serum lipase content in diagnosing pancreatitis]. 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Br Dent J. 1985 Jan 5;158(1):9-12. doi: 10.1038/sj.bdj.4805526. No abstract available.'}, {'pmid': '14202808', 'type': 'BACKGROUND', 'citation': 'DUMMETT CO, GUPTA OP. ESTIMATING THE EPIDEMIOLOGY OF ORAL PIGMENTATION. J Natl Med Assoc. 1964 Sep;56(5):419-20. No abstract available.'}, {'pmid': '20808602', 'type': 'BACKGROUND', 'citation': 'Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet Surg. 2009 Jul;2(2):110-1. doi: 10.4103/0974-2077.58529.'}, {'pmid': '29926948', 'type': 'BACKGROUND', 'citation': 'Cortellini P, Bissada NF. Mucogingival conditions in the natural dentition: Narrative review, case definitions, and diagnostic considerations. J Periodontol. 2018 Jun;89 Suppl 1:S204-S213. doi: 10.1002/JPER.16-0671.'}, {'pmid': '19406006', 'type': 'BACKGROUND', 'citation': 'Choo SJ, Ryoo IJ, Kim YH, Xu GH, Kim WG, Kim KH, Moon SJ, Son ED, Bae K, Yoo ID. Silymarin inhibits melanin synthesis in melanocyte cells. J Pharm Pharmacol. 2009 May;61(5):663-7. doi: 10.1211/jpp/61.05.0016.'}, {'pmid': '19135039', 'type': 'BACKGROUND', 'citation': 'Basiglio CL, Sanchez Pozzi EJ, Mottino AD, Roma MG. Differential effects of silymarin and its active component silibinin on plasma membrane stability and hepatocellular lysis. Chem Biol Interact. 2009 May 15;179(2-3):297-303. doi: 10.1016/j.cbi.2008.12.008. Epub 2008 Dec 24.'}, {'pmid': '17320726', 'type': 'BACKGROUND', 'citation': 'Bortoluzzi EA, Araujo GS, Guerreiro Tanomaru JM, Tanomaru-Filho M. Marginal gingiva discoloration by gray MTA: a case report. J Endod. 2007 Mar;33(3):325-7. doi: 10.1016/j.joen.2006.09.012. Epub 2006 Nov 22.'}, {'pmid': '2216381', 'type': 'BACKGROUND', 'citation': 'Ashri N, Gazi M. More unusual pigmentations of the gingiva. Oral Surg Oral Med Oral Pathol. 1990 Oct;70(4):445-9. doi: 10.1016/0030-4220(90)90207-9.'}, {'pmid': '29164181', 'type': 'BACKGROUND', 'citation': 'Alhabashneh R, Darawi O, Khader YS, Ashour L. Gingival depigmentation using Er:YAG laser and scalpel technique: A six-month prospective clinical study. Quintessence Int. 2018;49(2):113-122. doi: 10.3290/j.qi.a39267.'}, {'pmid': '33624200', 'type': 'BACKGROUND', 'citation': 'Altayeb W, Hamadah O, Alhaffar BA, Abdullah A, Romanos G. Gingival depigmentation with diode and Er,Cr:YSGG laser: evaluating re-pigmentation rate and patient perceptions. Clin Oral Investig. 2021 Sep;25(9):5351-5361. doi: 10.1007/s00784-021-03843-6. Epub 2021 Feb 23.'}, {'pmid': '34992657', 'type': 'BACKGROUND', 'citation': 'Jnaid Harb ZK, El-Sayed W, Alkhabuli J. Gingival Depigmentation Using Diode 980 nm and Erbium-YAG 2940 nm Lasers: A Split-Mouth Clinical Comparative Study. Int J Dent. 2021 Dec 28;2021:9424793. doi: 10.1155/2021/9424793. eCollection 2021.'}, {'pmid': '23031632', 'type': 'BACKGROUND', 'citation': 'Altaei T. The treatment of melasma by silymarin cream. BMC Dermatol. 2012 Oct 2;12:18. doi: 10.1186/1471-5945-12-18.'}, {'pmid': '34796640', 'type': 'BACKGROUND', 'citation': 'Al Hamad KQ, Almohammed SN, Baba NZ. Analysis of the effect magnitude of different parameters on smile attractiveness. J Esthet Restor Dent. 2022 Sep;34(6):888-896. doi: 10.1111/jerd.12834. Epub 2021 Nov 18.'}, {'pmid': '15530266', 'type': 'BACKGROUND', 'citation': 'Kauzman A, Pavone M, Blanas N, Bradley G. Pigmented lesions of the oral cavity: review, differential diagnosis, and case presentations. J Can Dent Assoc. 2004 Nov;70(10):682-3.'}], 'seeAlsoLinks': [{'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC3586829/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* 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?\n* What medical problems do participants have when using of Silymarin topically?\n\nParticipants will be:\n\nGroup 1 : The gingiva of the facial surfaces of the selected area will be de-epithelized by conventional method through blades no 15c.\n\nGroup 2 : The gingiva of the facial surfaces of the selected area will be de-epithelized by A Diode laser Device (serolaser).\n\nGroup 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients will be free from any systemic diseases according to criteria of Modified Cornell Medical Index\n2. Patient with physiologic pigmentation\n3. Non smoker\n4. Patient agree to sign the written consent\n5. Both genders\n\nExclusion Criteria:\n\n1. Pregnant and lactating women\n2. Systemic conditions affect melanin production\n3. Medications induce pigmentation or enlargement\n4. Those with known allergies to silymarin.'}, 'identificationModule': {'nctId': 'NCT07410156', 'acronym': 'Depigmentation', 'briefTitle': 'Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MN+Silymarin for depigmenation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Conventional Surgical method', 'description': 'depigmentation done using scalpel blade NO15 c', 'interventionNames': ['Procedure: Gingival Depigmentation with Conventional Method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diode Laser', 'description': 'diode lase with wave length 980 and laser tip 320 micron', 'interventionNames': ['Procedure: Gingival Depigmentation with Diode Laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MN with Silymarin application', 'description': '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.', 'interventionNames': ['Procedure: Gingival Depigmentation with Microneedling and Silymarin Application']}], 'interventions': [{'name': 'Gingival Depigmentation with Conventional Method', 'type': 'PROCEDURE', 'otherNames': ['Scalpel depigmentation'], 'description': '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.', 'armGroupLabels': ['Conventional Surgical method']}, {'name': 'Gingival Depigmentation with Diode Laser', 'type': 'PROCEDURE', 'otherNames': ['Laser depigmentation'], 'description': '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', 'armGroupLabels': ['Diode Laser']}, {'name': 'Gingival Depigmentation with Microneedling and Silymarin Application', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['MN with Silymarin application']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Fayyum', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Fayoum University. Fayoum 63514', 'role': 'CONTACT', 'email': 'odmed@fayoum.edu.eg', 'phone': '0842064056'}, {'name': 'Nayroz Mohammed Tarrad, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rehab Ahmed Osman, Lecturer', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fayoum University, Faculty of Dentistry, Department of Oral Medicine and Periodontology', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'centralContacts': [{'name': 'Tarek Taha TTAAbdeltawab, Researcher', 'role': 'CONTACT', 'email': 'tt1139@fayoum.edu.eg', 'phone': '+201100892663', 'phoneExt': '+201060406261'}, {'name': 'Rehab Ahmed Osman, Lecturer', 'role': 'CONTACT', 'email': 'rau11@fayoum.edu.eg', 'phone': '+201096992996', 'phoneExt': '+201153832971'}], 'overallOfficials': [{'name': 'Nayroz Mohammed Tarrad, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University'}, {'name': 'Rehab Ahmed Osman, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Operator', 'investigatorFullName': 'Tarek Taha Amin Abdeltawab', 'investigatorAffiliation': 'Fayoum University'}}}}