NCT06075641

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

Completed NA Last updated 10 October 2023

What this trial tests

NA trial testing Gingival depigmentation in Pigmentation in 40 participants. Completed in 1 January 2021.

Timeline

1 January 2017

Primary endpoint
1 January 2021

1 January 2021

Quick facts

Lead sponsor	King Abdulaziz University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 January 2017
Primary completion	1 January 2021
Estimated completion	1 January 2021

Drugs / interventions tested

• Gingival depigmentation

Conditions studied

• Pigmentation — all drugs for Pigmentation →
• Gingiva — all drugs for Gingiva →

Sponsor

King Abdulaziz University

Who can join

Adults 18 to 65, any sex, with Pigmentation or Gingiva. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.