Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation

Официальное название

Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation: A Randomized Controlled Clinical Trial

Обзор

To evaluate the usage of microneedling with platelet rich plasma as a gingival depigmentation method in comparison to microneedling alone for pigment intensity reduction. Pre-operative preparation phase includes ultrasonic scaling and oral hygiene instructions for all patients. Eligible patients will be randomly allocated into two groups. Clinical photographs: Clinical photographs will be taken at baseline, 1 and 6 months postoperatively. Intervention Group (Group A): Microneedling will be done with application of Platelet Rich Plasma for depigmentation. Control Group (Group B): microneedling will be done alone for depigmentation.

Подробное описание

In both groups:

Local anesthesia (Articaine with 1:100,000 Epinephrine( will be administered by infiltration technique).

A Dermapen device will be used to microneedle the gingival tissue (model M8) with 24 microneedles arranged in rows, which is adjusted according to the gingival thickness at the 6th mode speed of 700 cycles/min.

It will be laid perpendicular to gingival surface and MN will be carried out in horizontal, vertical and diagonal directions about four to five times for the whole hyperpigmented gingiva until mild microbleeding and mild erythema was clearly visible.

Once bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze.

Intervention group:

Patients receive injection of PRP in their Gingiva. To prepare PRP, 10mL of the patient's venous blood sample was taken manually with a sterile 10mL syringe and then centrifuged with 1300 RPM /10min, buffy coat and plasma were then extracted and re-centrifuged with 2000 RPM /10min. The injection of 1mL of PRP was immediately initiated with a 1 cc insulin syringe 30G, (0.1mL in each point of injection).

Postoperative Care:

Patients were instructed to refrain from mechanical oral hygiene practices in regard to the target region for the day of the operation following each visit to minimize mechanical damage to the treated areas.

If discomfort or itching was reported on the first day, analgesics were prescribed (Brufen 400 mg tablets, two times daily after meal).

Restricted spicy, acidic, and coloring food. Antiseptic mouth rinse 0,12% chlorhexidine rinse were prescribed, for 60 seconds two times a day for 14 days.

Apply an ice pack to the treated area for the first 24 hours.

Вмешательства

• Процедура Microneedling will be done with application of Platelet Rich Plasma for depigmentation.
  A Dermapen device will be used to microneedle the gingival tissue (model M8) with 24 microneedles arranged in rows, which is adjusted according to the gingival thickness at the 6th mode speed of 700 cycles/min(Mostafa and Alotaibi 2022). It will be laid perpendicular to gingival surface and MN will be carried out in horizontal, vertical and diagonal directions about four to five times for the whole hyperpigmented gingiva until mild microbleeding and mild erythema was clearly visible. Once bleedi
• Процедура Microneedling alone for Gingival Depigmentation.
  A Dermapen device will be used to microneedle the gingival tissue (model M8) with 24 microneedles arranged in rows, which is adjusted according to the gingival thickness at the 6th mode speed of 700 cycles/min(Mostafa and Alotaibi 2022). It will be laid perpendicular to gingival surface and MN will be carried out in horizontal, vertical and diagonal directions about four to five times for the whole hyperpigmented gingiva until mild microbleeding and mild erythema was clearly visible. Once blee

Первичные конечные точки

• Dummett-Gupta Oral Pigmentation Index (DOPI) [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Pain (Becker et al., 2018) [Срок оценки: 7 days after intervention.]

Критерии участия

Критерии включения

• • Patients exhibiting melanin hyperpigmentation in the anterior region of the upper or lower gingiva.

• Age ≥ 18 year old.
• Patients should be free from any systemic diseases according to modified Cornell Medical index (Abramson 1966).
• Non- smokers

Критерии исключения

• • Fully edentulous patients.

• Patients with endocrine disorders causing hyperpigmentation or drug induced gingival pigmentation. (Sreeja, Ramakrishnan et al. 2015)
• Pregnant or lactating females.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Египет · 3 центра

• Cairo university — Cairo
• Faculity of Dentistry, Cairo university — Cairo
• Faculity of Dentistry, Cairo university — Cairo

Идентификаторы

NCT: NCT07359339 · PER 3_3_1.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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