Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gingival Pigmentation
• Intervention / Treatment: Procedure: Microneedling will be done with application of Platelet Rich Plasma for depigmentation.; Procedure: Microneedling alone for Gingival 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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Manial
    • Cairo, El Manial, Egypt, 11562
      • Recruiting
      • Cairo University
      • Contact: Abdelrahman Sameer Abdullah, masters; Phone Number: +201275489234; Email: abdelrhman-sameer@dentistry.cu.edu.eg
  • El Manyl
    • Cairo, El Manyl, Egypt, 11555
      • Recruiting
      • Faculity of Dentistry, Cairo university
      • Contact: Abdelrahman Sameer Abdullah, masters; Phone Number: +201275489234; Email: abdelrhman-sameer@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze. 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 .	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 bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze. 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 .; Other Names: PRP
Active Comparator: Microneedling will be done 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 bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze.	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 bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dummett-Gupta Oral Pigmentation Index (DOPI)	the degree of gingival pigmentation is scored as 0, pink tissue [no clinical pigmentation]; 1 = mild light brown tissue [mild clinical pigmentation]; 2, medium brown or mixed brown and pink tissue [moderate clinical pigmentation]; or 3, deep brown/blue-black tissue [heavy clinical pigmentation]	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain (Becker et al., 2018)	Using Visual analogue score questionnaire, A number from 0 to 10 ( 10 for the most pain experience and 0 for no pain experience).	7 days after intervention.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 10, 2026

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Gingiva; Microneedling; Pigmentation; PRP
• Additional Relevant MeSH Terms: Therapeutics; Punctures; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Percutaneous Collagen Induction
• Other Study ID Numbers: PER 3_3_1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No