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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Surgical method | Other | depigmentation done using scalpel blade NO15 c |
|
| Diode Laser | Active Comparator | diode lase with wave length 980 and laser tip 320 micron |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gingival Depigmentation with Conventional Method | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) | From the enrollment till 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| post-operative pain | VAS ( visual analogue scale ) from 0 ( no pain ) to 10 ( severe pain ) | pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week ) |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | 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 | wound healing will recorded at 7,14,30 days postoperative ( from enrollment till 4 weeks ) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tarek Taha TTAAbdeltawab, Researcher | Contact | +201100892663 | +201060406261 | tt1139@fayoum.edu.eg |
| Rehab Ahmed Osman, Lecturer | Contact | +201096992996 | +201153832971 | rau11@fayoum.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nayroz Mohammed Tarrad, Professor | Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University | Principal Investigator |
| Rehab Ahmed Osman, Lecturer | Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum University, Faculty of Dentistry, Department of Oral Medicine and Periodontology | Recruiting | Al Fayyum | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16512768 | Background | 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. | |
| Background | Javali, M., Tapashetti, R., & Deshmukh, J. (2011). Esthetic management of gingival hyperpigmentation: Report of two cases. International Journal of Dental Clinics, 3, 115-116. | ||
| 26668465 |
| Label | URL |
|---|---|
| Related Info | View source |
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Masking Description
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| Gingival Depigmentation with Diode Laser | Procedure | 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 Application | Procedure | 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. |
|
| Background |
| 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. |
| 16253095 | Background | 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. |
| 18088764 | Background | 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. |
| 16170386 | Background | 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. |
| Background | 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. |
| 18206403 | Background | 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. |
| Background | 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. |
| 16127483 | Background | 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. |
| 16637061 | Background | 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. |
| 28050280 | Background | 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. |
| Background | 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. |
| Background | 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. |
| Background | Sanjeevini, H., Pudakalkatti, P., Soumya, B., & Aarati, N. (2012). Gingival depigmentation: 2 case reports. |
| Background | Prasad, S. S., Agrawal, N., & Reddy, N. R. (2010). Gingival depigmentation: A case report. |
| Background | Prabhuji, M., Madhupreetha, S., & Archana, V. (2011). Treatment of gingival hyperpigmentation for aesthetic purposes using the diode laser. |
| 38752063 | Background | 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. |
| 37153928 | Background | 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. |
| 7555659 | Background | Riederer J. [Value of the serum lipase content in diagnosing pancreatitis]. Dtsch Med Wochenschr. 1995 Oct 6;120(40):1378. No abstract available. German. |
| 14023164 | Background | CORRIGAN JJ, WELLNER D, MEISTER A. Determination of D-amino acid oxidase activity in insect tissues using D-allohydroxyproline as substrate. Biochim Biophys Acta. 1963 May 7;73:50-6. doi: 10.1016/0006-3002(63)90358-5. No abstract available. |
| 14779059 | Background | KOTCHER E, LEIKIN S. Histoplasmosis of infants with a report of 7 cases. J Ky State Med Assoc. 1950 Oct;48(10):459-66. No abstract available. |
| 3854825 | Background | Gutierrez Valdes S. [The child's creative and psychographic expression. A study of the different stages of a child]. Rev Cubana Enferm. 1985 May-Aug;1(2):120-8. No abstract available. Spanish. |
| 3882105 | Background | Dummett CO. Pertinent considerations in oral pigmentations. Br Dent J. 1985 Jan 5;158(1):9-12. doi: 10.1038/sj.bdj.4805526. No abstract available. |
| 14202808 | Background | DUMMETT CO, GUPTA OP. ESTIMATING THE EPIDEMIOLOGY OF ORAL PIGMENTATION. J Natl Med Assoc. 1964 Sep;56(5):419-20. No abstract available. |
| 20808602 | Background | Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet Surg. 2009 Jul;2(2):110-1. doi: 10.4103/0974-2077.58529. |
| 29926948 | Background | 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. |
| 19406006 | Background | 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. |
| 19135039 | Background | 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. |
| 17320726 | Background | 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. |
| 2216381 | Background | 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. |
| 29164181 | Background | 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. |
| 33624200 | Background | 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. |
| 34992657 | Background | 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. |
| 23031632 | Background | Altaei T. The treatment of melasma by silymarin cream. BMC Dermatol. 2012 Oct 2;12:18. doi: 10.1186/1471-5945-12-18. |
| 34796640 | Background | 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. |
| 15530266 | Background | 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. |
| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| D000097244 | Percutaneous Collagen Induction |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
| D012046 | Rehabilitation |
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