Melanin HyperpigmentationNCT06886100
Melanin Recurrence in Scalpel and LASER Gingival Depigmentation in Thin and Thick Phenotypes.
A study testing Diode laser and Scalpel No 15 in people with Melanin Hyperpigmentation, run by Thamar University at 1 site in Yemen.
Trial summary
This study aimed to compare melanin pigmentation recurrence, pain perception and wound healing between laser and scalpel surgeries in thin and thick gingival phenotypes.Thirty patients (60 sites) were included in this study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Melanin Hyperpigmentation
- What is being tested?
- Diode laser and Scalpel No 15
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteYemen
- Study dates
- 4 Mar 2024to 18 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged at least 20 years, (ii) had bilateral physiologic melanin hyperpigmentation of gingiva (dark gums) in the anterior segment with severe grade II melanin hyperpigmentation (according to modification of melanin index categories 1977), (iii) periodontally healthy with good oral hygiene, (iv) had esthetic concern, (v) systemically healthy, (vi) no dental crowding and (vii) those willing to undergo minor surgical procedures.
Who cannot join
- any systemic disease associated with pathological hyperpigmentation), (ii) non-treated periodontal disease, (iii) chronic smokers, (iv) subjects with a mouth breathing habit (ii) subjects with crown restorations or fillings involving the incisal edge on anterior maxillary teeth, (v) non-compliant patients (vi) missing any of the six maxillary anterior teeth and having Millers Class III or Class IV recession (vii) pregnant or lactating females and (viii) (ix) gingival pigmentation of hemoglobin, melanoid, melanoma and carotene , (x) Gingival pigmentation adjacent to amalgam restoration, and (xi) Long-term usage of antimalarial drugs and minocycline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Melanin Recurrence, Pain Perception and Wound Healing in Scalpel and LASER Gingival Depigmentation in Thin and Thick Phenotypes: a Comparative Clinical Study.
This study aimed to compare melanin pigmentation recurrence, pain perception and wound healing between laser and scalpel surgeries in thin and thick gingival phenotypes.Thirty patients (60 sites) were included in this study. They had bilateral physiologic melanin hyperpigmentation in the upper anterior segment with severe grade II melanin hyperpigmentation. The patients were divided into two groups: each with fifteen patients with severe grade II melanin pigmentation, one with thin gingiva and another with thick gingiva. Melanin depigmentation was done in one side using scalpel no. 15 and other side with diode laser.
Read the detailed description
Background: Removal of unsightly pigmented gingiva is the need for a pleasant and confident smile. Many studies were done to study the melanin recurrence in both surgical and laser melanin depigmentation. To best of our knowledge, there is no published article regarding comparison of melanin recurrence between both techniques taking in consideration the gingival phenotype. So this study aimed to compare melanin pigmentation recurrence, pain perception and wound healing between laser and scalpel surgeries in thin and thick gingival phenotypes.
Methods: Thirty patients (60 sites) were included in this study. They had bilateral physiologic melanin hyperpigmentation in the upper anterior segment with severe grade II melanin hyperpigmentation. The patients were divided into two groups: each with fifteen patients with severe grade II melanin pigmentation, one with thin gingiva and another with thick gingiva. Melanin depigmentation was done in one side using scalpel no. 15 and other side with diode laser.
- Conditions
- Melanin Hyperpigmentation
- Being tested
- Diode laser, Scalpel No 15
- Keywords
- Depigmentation; Healing; Laser; Melanin; Pain; Phenotype
- Medical subject headings
- Vitiligo, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserDevice
Diode Laser is a semiconductor device similar to a light-emitting diode in which a diode pumped directly with electrical current can create lasing conditions at the diode's junction. It is used in periodontal surgery as melanin depigmentation
Scalpel No 15Device
The No.15 blade has a small curved cutting edge and is the most popular blade shape ideal for making short and precise incisions.
| Study group | Role | What they receive |
|---|---|---|
| Patients with thin gingival phenotype | Active comparator | Thin gingival phenotypes are delicate, highly scalloped and translucent in appearance (Fig. 3). The soft tissue appears delicate and friable with a minimal amount of the attached gingiva. Receives: Device: Diode laser; Device: Scalpel No 15 |
| Patients with thick gingival phenotype | Active comparator | . The thick biotype is dense and fibrotic with a wide zone of attachment, thus making it more resistant to recession. Thin gingival biotype is a delicate, highly scalloped soft tissue and is more prone to recession, bleeding, and inflammation. Receives: Device: Diode laser; Device: Scalpel No 15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanin recurrence
It is the reappearance of melanin pigmentation following a period of time after depigmentation.
Measured: One week, three months, and six months postoperatively
Secondary outcomes (2)
Wound healing
Wound healing was evaluated as per the list of clinical observations and patient responses as: Complete epithelization, incomplete epithelization, ulcer or tissue defect or necrosis.
Measured: One week and one month after surgery.
Pain perception (VAS)
Pain perception via the Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' (Fig. 1) [1]. The patient is asked to mark his pain level on the line between the two endpoints.
Measured: Immediately after surgery, one day, one week and one month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start4 Mar 2024
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanin HyperpigmentationStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Thirty patients (60 sites) were included in this study. They had bilateral physiologic melanin hyperpigmentation in the upper anterior segment with severe grade II melanin hyperpigmentation. The patients were divided into two groups: each with fifteen patients with severe grade II melanin pigmentation, one with thin gingiva and another with thick gingiva. Melanin depigmentation was done in one side using scalpel no. 15 and other side with diode laser.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thamar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wadhah Abdulnasser Noman Alhajj, Thamar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886100
- Sponsor's protocol ID
- reference number (2024/4)
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Because I do not understand exactly what do you mean by sharing individual participant data (IPD)
Publications
Grover HS, Dadlani H, Bhardwaj A, Yadav A, Lal S. Evaluation of patient response and recurrence of pigmentation following gingival depigmentation using laser and scalpel technique: A clinical study. J Indian Soc Periodontol. 2014 Sep;18(5):586-92. doi: 10.4103/0972-124X.142450.
PubMed 25425820
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanin Recurrence, Pain Perception and Wound Healing in Scalpel and LASER Gingival Depigmentation in Thin and Thick Phenotypes: a Comparative Clinical Study.
- ClinicalTrials.gov ID
- NCT06886100
- Acronym / sponsor ID
- reference number (2024/4)
- Conditions
- Melanin Hyperpigmentation
- Keywords
- Depigmentation; Healing; Laser; Melanin; Pain; Phenotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Thamar UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 20 Mar 2025 (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.
This study aimed to compare melanin pigmentation recurrence, pain perception and wound healing between laser and scalpel surgeries in thin and thick gingival phenotypes.Thirty patients (60 sites) were included in this study. They had bilateral physiologic melanin hyperpigmentation in the upper anterior segment with severe grade II melanin hyperpigmentation. The patients were divided into two groups: each with fifteen patients with severe grade II melanin pigmentation, one with thin gingiva and another with thick gingiva. Melanin depigmentation was done in one side using scalpel no. 15 and other side with diode laser.
Detailed description
Background: Removal of unsightly pigmented gingiva is the need for a pleasant and confident smile. Many studies were done to study the melanin recurrence in both surgical and laser melanin depigmentation. To best of our knowledge, there is no published article regarding comparison of melanin recurrence between both techniques taking in consideration the gingival phenotype. So this study aimed to compare melanin pigmentation recurrence, pain perception and wound healing between laser and scalpel surgeries in thin and thick gingival phenotypes.
Methods: Thirty patients (60 sites) were included in this study. They had bilateral physiologic melanin hyperpigmentation in the upper anterior segment with severe grade II melanin hyperpigmentation. The patients were divided into two groups: each with fifteen patients with severe grade II melanin pigmentation, one with thin gingiva and another with thick gingiva. Melanin depigmentation was done in one side using scalpel no. 15 and other side with diode laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Thirty patients (60 sites) were included in this study. They had bilateral physiologic melanin hyperpigmentation in the upper anterior segment with severe grade II melanin hyperpigmentation. The patients were divided into two groups: each with fifteen patients with severe grade II melanin pigmentation, one with thin gingiva and another with thick gingiva. Melanin depigmentation was done in one side using scalpel no. 15 and other side with diode laser.
| Arm | Type | Receives |
|---|---|---|
| Patients with thin gingival phenotype | Active comparator | Device: Diode laser, Device: Scalpel No 15Thin gingival phenotypes are delicate, highly scalloped and translucent in appearance (Fig. 3). The soft tissue appears delicate and friable with a minimal amount of the attached gingiva. |
| Patients with thick gingival phenotype | Active comparator | Device: Diode laser, Device: Scalpel No 15. The thick biotype is dense and fibrotic with a wide zone of attachment, thus making it more resistant to recession. Thin gingival biotype is a delicate, highly scalloped soft tissue and is more prone to recession, bleeding, and inflammation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Be aged at least 20 years, (ii) had bilateral physiologic melanin hyperpigmentation of gingiva (dark gums) in the anterior segment with severe grade II melanin hyperpigmentation (according to modification of melanin index categories 1977), (iii) periodontally healthy with good oral hygiene, (iv) had esthetic concern, (v) systemically healthy, (vi) no dental crowding and (vii) those willing to undergo minor surgical procedures.
Key exclusion criteria (1 listed)
- any systemic disease associated with pathological hyperpigmentation), (ii) non-treated periodontal disease, (iii) chronic smokers, (iv) subjects with a mouth breathing habit (ii) subjects with crown restorations or fillings involving the incisal edge on anterior maxillary teeth, (v) non-compliant patients (vi) missing any of the six maxillary anterior teeth and having Millers Class III or Class IV recession (vii) pregnant or lactating females and (viii) (ix) gingival pigmentation of hemoglobin, melanoid, melanoma and carotene , (x) Gingival pigmentation adjacent to amalgam restoration, and (xi) Long-term usage of antimalarial drugs and minocycline.
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 |
|---|---|---|
| Diode laserDiode Laser is a semiconductor device similar to a light-emitting diode in which a diode pumped directly with electrical current can create lasing conditions at the diode's junction. It is used in periodontal surgery as melanin depigmentation | Device | Patients with thick gingival phenotype, Patients with thin gingival phenotype |
| Scalpel No 15The No.15 blade has a small curved cutting edge and is the most popular blade shape ideal for making short and precise incisions. | Device | Patients with thick gingival phenotype, Patients with thin gingival phenotype |
Primary outcome
Melanin recurrence
Time frame: One week, three months, and six months postoperatively
It is the reappearance of melanin pigmentation following a period of time after depigmentation.
2 secondary outcomes
Wound healing
Time frame: One week and one month after surgery.
Pain perception (VAS)
Time frame: Immediately after surgery, one day, one week and one month postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background: PubMed 25425820Grover HS, Dadlani H, Bhardwaj A, Yadav A, Lal S. Evaluation of patient response and recurrence of pigmentation following gingival depigmentation using laser and scalpel technique: A clinical study. J Indian Soc Periodontol. 2014 Sep;18(5):586-92. doi: 10.4103/0972-124X.142450.
- It represent the site for a research which was a main source of study.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Because I do not understand exactly what do you mean by sharing individual participant data (IPD)
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser and Scalpel No 15 in people with Melanin Hyperpigmentation, run by Thamar University at 1 site in Yemen.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melanin recurrence (time frame: One week, three months, and six months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06886100, which also lists 1 linked publication.
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 20 Mar 2025.