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

NCT06886100 | Completed

• 1 other identifier: reference number (2024/4)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanin Hyperpigmentation

Keywords

Depigmentation; Healing; Laser; Melanin; Pain; Phenotype

Outcome Measures

Primary Outcomes (1)

• Melanin recurrence

  It is the reappearance of melanin pigmentation following a period of time after depigmentation.

  One week, three months, and six months postoperatively

Secondary Outcomes (2)

• Wound healing

  One week and one month after surgery.

• Pain perception (VAS)

  Immediately after surgery, one day, one week and one month postoperatively

Study Arms (2)

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.

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.

Device: Diode laser; Device: Scalpel No 15

Interventions

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

Patients with thick gingival phenotype; Patients with thin gingival phenotype

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.

Patients with thick gingival phenotype; Patients with thin gingival phenotype

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Thamar University: lead

Study Sites (1)

Wadhah dental center

Sanaa, Sanaa Governorate, 009671, Yemen

Location

Related Publications (1)

• 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.

  PMID: 25425820 BACKGROUND

Related Links

• It represent the site for a research which was a main source of study.

MeSH Terms

Conditions

Vitiligo; Pain

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Wadhah Alhajj

Model Details: 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 Record Dates

• First Submitted: March 11, 2025
• First Posted: March 20, 2025
• Study Start: March 4, 2024
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

YE (1)