Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation

ConditionGingival Pigmentation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

• Fully edentulous patients.

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

Pregnant or lactating females.

Trial design

Design model

Parallel

Treatments tested in this trial

Microneedling will be done with application of Platelet Rich Plasma for depigmentation.
Procedure/Surgery
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 .
Microneedling alone for Gingival Depigmentation.
Procedure/Surgery
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.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: Microneedling will be done with application of Platelet Rich Plasma for depigmentation.Experimental treatment 1 intervention

Group B: Microneedling will be done alone for Gingival depigmentation.Active comparator 1 intervention

Trial outcomes

Primary outcomes

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 \[heavy clinical pigmentation\]

Time frame

6 months

Secondary outcomes

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).

Time frame

7 days after intervention.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

Apply now