Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microneedling will be done with application of Platelet Rich Plasma for depigmentation., Microneedling alone for Gingival Depigmentation..
- Who it may be relevant to
- Registry conditions: Gingival Pigmentation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation: A Randomized Controlled Clinical Trial
Overview
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.
Detailed description
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.
Interventions
- Procedure 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 - Procedure 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
Primary outcome measures
- Dummett-Gupta Oral Pigmentation Index (DOPI) [Time frame: 6 months]
Secondary outcome measures (1)
- Pain (Becker et al., 2018) [Time frame: 7 days after intervention.]
Eligibility criteria
Inclusion criteria
- • 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
Exclusion criteria
- • Fully edentulous patients.
- Patients with endocrine disorders causing hyperpigmentation or drug induced gingival pigmentation. (Sreeja, Ramakrishnan et al. 2015)
- Pregnant or lactating females.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 3 centers
- Cairo university — Cairo
- Faculity of Dentistry, Cairo university — Cairo
- Faculity of Dentistry, Cairo university — Cairo
Identifiers
NCT: NCT07359339 · PER 3_3_1.1