Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation

NCT07359339 | Recruiting DMC

• 1 other identifier: PER 3_3_1.1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Gingival Pigmentation

Keywords

Pigmentation; Gingiva; PRP; Microneedling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain (Becker et al., 2018)

  7 days after intervention.

Study Arms (2)

Microneedling will be done with application of Platelet Rich Plasma for depigmentation.

EXPERIMENTAL

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.

Microneedling will be done alone for Gingival depigmentation.

ACTIVE COMPARATOR

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.

Interventions

Microneedling alone for Gingival Depigmentation. PROCEDURE

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.

Microneedling will be done alone for Gingival depigmentation.

Microneedling will be done with application of Platelet Rich Plasma for depigmentation. PROCEDURE

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 .

Also known as: PRP

Microneedling will be done with application of Platelet Rich Plasma for depigmentation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (3)

Cairo university

Cairo, El Manial, 11562, Egypt

RECRUITING

Faculity of Dentistry, Cairo university

Cairo, El Manyl, 11555, Egypt

RECRUITING

Faculity of Dentistry, Cairo university

Cairo, El Manyl, 11555, Egypt

RECRUITING

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 22, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)