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Completed

NCT Number: NCT06886100

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wadhah dental center

Sanaa, Sanaa Governorate, 009671, Yemen

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diode laser

Device

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 15

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Wound healing

    Time frame: One 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.

  2. Pain perception (VAS)

    Time frame: Immediately after surgery, one day, one week and one month postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Thamar University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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