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Melanin Recurrence in Scalpel and LASER Gingival Depigmentation in Thin and Thick Phenotypes.

Melanin Recurrence, Pain Perception and Wound Healing in Scalpel and LASER Gingival Depigmentation in Thin and Thick Phenotypes: a Comparative Clinical Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06886100
Enrollment
30
Registered
2025-03-20
Start date
2024-03-04
Completion date
2024-12-18
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanin Hyperpigmentation

Keywords

Depigmentation; Healing; Laser; Melanin; Pain; Phenotype

Brief 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. 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.

Interventions

DEVICEDiode laser

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

DEVICEScalpel No 15

The No.15 blade has a small curved cutting edge and is the most popular blade shape ideal for making short and precise incisions.

Sponsors

Thamar University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(i) 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.

Exclusion criteria

(i) 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.

Design outcomes

Primary

MeasureTime frameDescription
Melanin recurrenceOne week, three months, and six months postoperativelyIt is the reappearance of melanin pigmentation following a period of time after depigmentation.

Secondary

MeasureTime frameDescription
Wound healingOne week and one month after surgery.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.
Pain perception (VAS)Immediately after surgery, one day, one week and one month postoperativelyPain 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.

Countries

Yemen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026