Gingival PigmentationNCT07359339
Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation
A study testing Microneedling will be done with application of Platelet Rich Plasma for depigmentation. and Microneedling alone for Gingival Depigmentation. in people with Gingival Pigmentation, run by Cairo University at 3 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Pigmentation
- What is being tested?
- Microneedling will be done with application of Platelet Rich Plasma for depigmentation. and Microneedling alone for Gingival Depigmentation.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Oct 2025to 10 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • Fully edentulous patients.
- Patients with endocrine disorders causing hyperpigmentation or drug induced gingival pigmentation. (Sreeja, Ramakrishnan et al. 2015)
- Pregnant or lactating females.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt3 sites, 3 recruiting
- Recruiting
Cairo university
Cairo, El Manial, 11562
Abdelrahman Sameer Abdullah, masters, +201275489234, abdelrhman-sameer@dentistry.cu.edu.eg
- Recruiting
Faculity of Dentistry, Cairo university
Cairo, El Manyl, 11555
Abdelrahman Sameer Abdullah, masters, +201275489234, abdelrhman-sameer@dentistry.cu.edu.eg
Abdelrahman Sameer Abdullah, Masters
- Recruiting
Faculity of Dentistry, Cairo university
Cairo, El Manyl, 11555
Abdelrahman Sameer Abdullah, masters, +201275489234, abdelrhman-sameer@dentistry.cu.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingival Pigmentation
- Being tested
- Microneedling will be done with application of Platelet Rich Plasma for depigmentation., Microneedling alone for Gingival Depigmentation.
- Keywords
- Pigmentation, Gingiva, PRP, Microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling will be done with application of Platelet Rich Plasma for depigmentation.Procedure or surgery
Also called PRP
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 or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Procedure: Microneedling alone for Gingival Depigmentation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 6 months
Secondary outcomes (1)
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).
Measured: 7 days after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PigmentationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Sameer Abdullah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359339
- Sponsor's protocol ID
- PER 3_3_1.1
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07359339
- Acronym / sponsor ID
- PER 3_3_1.1
- Conditions
- Gingival Pigmentation
- Keywords
- Pigmentation, Gingiva, PRP, Microneedling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedling will be done with application of Platelet Rich Plasma for depigmentation. | Experimental | 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 . |
| Microneedling will be done alone for Gingival depigmentation. | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients exhibiting melanin hyperpigmentation in the anterior region of the upper or lower gingiva.
Key exclusion criteria (3 listed)
- • Fully edentulous patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedling will be done with application of Platelet Rich Plasma for depigmentation.Also: PRPA 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 or surgery | Microneedling will be done with application of Platelet Rich Plasma for depigmentation. |
| 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. | Procedure or surgery | Microneedling will be done alone for Gingival depigmentation. |
Primary outcome
Dummett-Gupta Oral Pigmentation Index (DOPI)
Time frame: 6 months
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]
1 secondary outcome
Pain (Becker et al., 2018)
Time frame: 7 days after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faculity of Dentistry, Cairo university
Cairo, Egypt
Faculity of Dentistry, Cairo university
Cairo, Egypt
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling will be done with application of Platelet Rich Plasma for depigmentation. and Microneedling alone for Gingival Depigmentation. in people with Gingival Pigmentation, run by Cairo University at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dummett-Gupta Oral Pigmentation Index (DOPI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.