Health TrialsbyHealthPanel

Gingival Hyperpigmentation Treatment

ConditionsGingival PigmentationDepigmentationVitamin CGlutathione
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Score0:absence of pigmentation

Score1:spotsofbrowntoblackcolororpigments

Score2:browntoblackpatchesbutnotdiffusepigmentation

Score3:diffuse brown to black pigmentation,marginal,and attached.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin c and glutathione

    Drug

    Vitamins c and glutathione injection that usually used for cosmetic skin care (whitening)

  • Surgical depigmentation

    Procedure/Surgery

    Removal of gingival pigmentation by scalpel

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm1:(Vit C & glutathione injection)Experimental treatment 1 intervention
Group B: ATM 2: surgical depigmentationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Degree of gingival pigmentation by Takashi index (Hanioka et al., 2005)

Degree of gingival pigmentation 0: no pigmentation 1. solitary unit (s) of pigmentation in papillary gingiva without extension between neighboring solitary units 2. formation of continuous ribbon extending from neighboring solitary units)

Time frame
baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month
2

Degree of gingival pigmentation by Gingival pigmentation index (Kumar et al., 2013)

Score 0: absence Score 1: spots of brown to black Score 2: brown to black patches but not diffuse Score 3: diffuse brown to black pigmentation

Time frame
The color assessment will be evaluated in the daylight and by examining the regular digital photographs which will be taken pre-operative (day of the procedure / day 1), and post-operatively after 1 month and 9 months.

Secondary outcomes

1

Pain score

VAS scores pain will be divided into ten numerical parts consisting of one cm each on a horizontal line with two endpoints (left and right), with "0" representing "no pain" to "10" representing "severe pain."

Time frame
visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
2

Itching

A vertical scale for wound itching was measured with a scale with five scores: no itching (0) mild itching (1point) moderate itching (2 points) severe itching (3 points) extremely severe (4 points)

Time frame
visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
3

Patient satisfaction

using a 5- graded self-assessment analysis (Huh et al. 2003). excellent (grade 4: improved over 75%) good (grade 3: improved 50e75%) moderate (grade 2: improved 25e50%) fair (grade 1: improved less than 25%) no change or worse (grade 0: not improved or darkened)

Time frame
At the end of the follow up period ( 9 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Fayoum University

Collaborator

Source ClinicalTrials.gov
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