ClinicalTrials.Veeva

Menu

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

T

Thamar University

Status

Completed

Conditions

Melanin Hyperpigmentation

Treatments

Device: Diode laser
Device: Scalpel No 15

Study type

Interventional

Funder types

Other

Identifiers

NCT06886100
reference number (2024/4)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Patients with thin gingival phenotype
Active Comparator group
Description:
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.
Treatment:
Device: Scalpel No 15
Device: Diode laser
Patients with thick gingival phenotype
Active Comparator group
Description:
. 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.
Treatment:
Device: Scalpel No 15
Device: Diode laser

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems