Post Gingival Depigmentation Assessment: Comparison of Surgical Stripping vs (Er,Cr:YSGG) Laser

NCT06075641 | Completed

• 1 other identifier: 077-16
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The appearance and health of the gingiva significantly contribute to an aesthetically pleasing smile. Pink gingiva indicates healthy gums and is generally preferred over dark or mixed colors. However, gingival color varies among individuals based on factors such as race, geography, gum health, epithelial thickness, vascular supply, keratinization level, and pigments in the epithelium layers. Four primary pigments define mucosa color: melanin, oxygenated hemoglobin (Hb), carotenoids, and reduced Hb. Melanin notably affects excessive gingival pigmentation. Gingival melanin hyperpigmentation, sometimes called racial pigmentation, is a genetic trait present in many ethnic groups due to excess melanin deposition in the epithelial layers. While not a medical concern, this hyperpigmentation can be unattractive, especially for those with a gummy smile. As a result, many seek treatments to reduce or eliminate this pigmentation. Various methods for gingival depigmentation exist, including surgical scraping, scalpel technique, bur abrasion, free gingival graft, gingivectomy, cryosurgery, electrosurgery, chemical treatments, and lasers. A significant challenge with these treatments is gingival repigmentation or the reappearance of melanin post-procedure. For years, the scalpel technique was the standard. It's a straightforward and economical method that involves removing the gingival epithelium and some underlying tissue. Although it promotes quick healing, the procedure can cause bleeding, necessitating local anesthesia and post-operative dressings. Due to the associated discomfort, researchers have sought equally effective alternatives. Laser ablation has become a popular choice among dental professionals and patients. Lasers like carbon dioxide (CO2), diode, argon, ruby, Nd:YAG (neodymium-doped yttrium aluminum garnet) , and Er:YAG (erbium-doped yttrium aluminium garnet) have been proven effective through numerous studies. Lasers present benefits such as minimal post-operative pain, ease of use, and quicker treatment times. Recurrence rates post-laser surgery (1.16%) are lower than with the scalpel technique (4.25%). However, lasers also have downsides, including high costs, potential for thermal damage, and the risk of deep penetration. One laser, the Erbium-chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG), has been FDA-approved for certain dental procedures but hasn't been widely used for gingival depigmentation. Preliminary findings suggest it offers advantages like reduced pain and faster healing compared to other lasers. In a case study involving two patients, the Er,Cr:YSGG laser effectively removed gingival pigmentation, with no recurrence observed after six months. This clinical trial aimed to compare the efficacy and recurrence rates between the conventional scalpel technique and the Er,Cr:YSGG laser technique. The hypothesis suggests that the Er,Cr:YSGG laser might be a superior treatment for gingival hyperpigmentation compared to other methods.

Conditions

Pigmentation; Gingiva

Keywords

gingival pigmentation; depigmentation; Er,Cr:YSGG; laser

Outcome Measures

Primary Outcomes (2)

• Oral pigmentation index (DOPI)

  This index of oral pigmentation is the commonly used index due to its simplicity and ease of use. The scores are as follows: 0 = No clinical pigmentation (pink-colored gingiva) 1. Mild clinical pigmentation (mild light brown color) 2. Moderate clinical pigmentation (medium brown or mixed pink and brown color) 3. Heavy clinical pigmentation (deep brown or bluish black color)

  Pre surgical, 1 month post op, 12 months post op

• Gingival melanosis record (GMR)

  A quantitative analysis method using clinical oral photographs

  Pre surgical, 1 month post op, 12 months post op

Study Arms (2)

Surgical Stripping

ACTIVE COMPARATOR

Procedure: Gingival depigmentation

Erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) Laser Techniques

EXPERIMENTAL

Procedure: Gingival depigmentation

Interventions

Gingival depigmentation PROCEDURE

Gingival depigmentation is the most widely used periodontal procedure to remove or reduce the melanotic areas. Various techniques can be employed to effectively carry out the depigmentation procedure, including surgical scraping, scalpel technique, bur abrasion, free gingival graft, gingivectomy, cryosurgery, electrosurgery, chemical therapies, and different types of lasers

Erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) Laser Techniques; Surgical Stripping

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Periodontally healthy subjects with concerns about their esthetics and presence of gingival hyperpigmentation in the upper arch

You may not qualify if:

• (1) smokers or were previous smokers
• (2) had a systemic disease/condition,
• (3) were pregnant/lactating
• (4) had gingivitis, periodontitis or any other periodontal disease
• (5) acquired amalgam pigmentation were excluded from the study

Sponsors & Collaborators

• King Abdulaziz University: lead

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Periodontology Department

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: January 1, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: October 10, 2023

Record last verified: 2023-10