Recruiting PHASE2 Gingival Pigmentation

New treatment option for Gingival Pigmentation

Official title Gingival Hyperpigmentation Treatment

ClinicalTrials.gov ID: NCT07595705

What this study is testing

What is Vitamin c and glutathione?

Vitamin c and glutathione is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for gingival pigmentation.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
It is a clinical study conducted to evaluate the effect of vitamin C and Glucathonine injection of pigmented gingival tissue versus surgical removal by scalpel
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older. Healthy volunteers may be eligible.

You may be able to join if

  • The selection criteria were done according to Gingival pigmentation index is as follows (Dummett and Bolden)10:
  • Score0:absence of pigmentation
  • Score1:spotsofbrowntoblackcolororpigments
  • Score2:browntoblackpatchesbutnotdiffusepigmentation
  • Score3:diffuse brown to black pigmentation,marginal,and attached. Patients who have Dummett and Bolden index score 1, 2, or 3 will be included in...

You likely can't join if

  • systemic diseases associated with pathological hyperpigmentation or improper delayed wound healing (uncontrolled diabetes, autoimmune diseases, etc.)
  • pregnant and lactating mothers
  • usage of chlorhexidine or povidone iodine
  • Local causes (smoking)
  • periodontal diseases (plaque and non-plaque induced gingivitis or periodontitis)
  • non compliant patients
See the full eligibility criteria
Who can join
  • The selection criteria were done according to Gingival pigmentation index is as follows (Dummett and Bolden)10:
  • Score0:absence of pigmentation
  • Score1:spotsofbrowntoblackcolororpigments
  • Score2:browntoblackpatchesbutnotdiffusepigmentation
  • Score3:diffuse brown to black pigmentation,marginal,and attached. Patients who have Dummett and Bolden index score 1, 2, or 3 will be included in addition to the following criteria:
  • above 18yrs
  • systemically free
  • physiologic gingival hyperpigmentation related to esthetic region
  • well maintained oral hygiene and willing to undergo minor surgical procedures
What rules you out
  • systemic diseases associated with pathological hyperpigmentation or improper delayed wound healing (uncontrolled diabetes, autoimmune diseases, etc.)
  • pregnant and lactating mothers
  • usage of chlorhexidine or povidone iodine
  • Local causes (smoking)
  • periodontal diseases (plaque and non-plaque induced gingivitis or periodontitis)
  • non compliant patients

The study team makes the final eligibility decision.

Where it's taking place

  • Al Fayyum, Faiyum Governorate, Egypt

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Al Fayyum, Faiyum Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.