NCT Number: NCT07410156
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Al Fayyum, Egypt
Location status: Recruiting
Fayoum University. Fayoum 63514
CONTACT
Nayroz Mohammed Tarrad, Professor
PRINCIPAL_INVESTIGATOR
Rehab Ahmed Osman, Lecturer
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Scalpel 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
Other names: Laser depigmentation
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.
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 )
Time frame: pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week )
VAS ( visual analogue scale ) from 0 ( no pain ) to 10 ( severe pain )
Time frame: wound healing will recorded at 7,14,30 days postoperative ( from enrollment till 4 weeks )
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
Contact information is provided by the study sponsor or research team.
Rehab Ahmed Osman, Lecturer
CONTACT
+201096992996 ext. +201153832971
Tarek Taha TTAAbdeltawab, Researcher
CONTACT
+201100892663 ext. +201060406261
Fayoum University
Other
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
Acronym: Depigmentation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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