CClinicalTrials.gg
CompletedNCT05608057Updated Apr 27, 2023

Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation

An interventional study of Vitamin C mesotherapy and Diode laser in Gingival Pigmentation, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Physiologic pigmentation affects the gingival esthetics. Laser ablation has been recently used as the most effective and reliable technique for gingival depigmentation. However, the high cost of laser technology limits its use in dental practice. Vitamin C/Ascorbic acid mesotherapy has been proposed as a minimally invasive, safe, cost-effective new modality of treatment.

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Conditions studied

  • Gingival Pigmentation
03

In context

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults between 18 and 45 years old with physiologic melanin pigmentation in the anterior esthetic portion of the maxillary or mandibular gingiva.
  • Systemically free

Exclusion criteria

Exclusion Criteria:

  • Smokers.
  • Drugs intake, which associates with gingival melanin pigmentation.
  • Pregnant and lactating women.
  • Patients with known hypersensitivity to ascorbic acid.
  • Patients with bad oral hygiene.
  • Pigmentation of the gingiva due to heavy metal ingestion
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Vitamin C mesotherapy

    Other: Vitamin C mesotherapy

  • Active comparator
    Diode laser

    Radiation: Diode laser

Interventions

  • OtherVitamin C mesotherapy

    Vitamin C intra-mucosal injection; in which the site of interest will be anesthetized using a topical anesthetic agent (lidocaine gel or xylocaine gel) or infiltration anesthesia, followed by intra-mucosal field injections of 1-1.5 ml Cevarol (L-Ascorbic acid 1000 mg/5 ml

  • RadiationDiode laser

    Diode laser ablation: in which the site of interest will be anesthetized using infiltration anesthesia, followed by laser ablation. 980nm Diode laser will be applied using the following setting parameters: continuous mode with 980nm wavelength at 1.5 W output power.

06

What researchers measure

Primary outcomes

  1. Change in gingival pigmentation score

    Score 0: Absence of pigmentation Score 1: Spots of brown to black color or pigments. Score 2: Brown to black patches but not diffuse pigmentation Score 3: Diffuse brown to black pigmentation, marginal, and attached gingiva

    Time frame: baseline, 1 month, 2 months

Secondary outcomes

  1. Change in pain score

    Visual Analogue Scale (VAS) is a simple measurement tool that measures the intensity of pain as recorded by the patient. 10 point visual analog scale of pain rating, the left side is marked "no pain" and the right side marked "worst pain imaginable.

    Time frame: up to 1 week

  2. Patient satisfaction

    After 2 months, patients will be asked to answer three questions to evaluate the level of satisfaction with each technique: Did you notice a cosmetic change 2 months after the treatment? (1) No, (2) Moderate, (3) Marked Did treatment meet your expectation? (1) No, (2) yes, (3) Over and above Would you repeat treatment if necessary? (1) No, (2) yes

    Time frame: after 2 months

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Study locations

1 site
  • Alexandria Faculty of Dentistry
    Alexandria, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05608057
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Assistant lecturer of DPH and Clinical statistician, Alexandria University) — Sponsor-investigator
First posted
Nov 8, 2022
Start date
Oct 22, 2022
Primary completion
Mar 24, 2023
Completion
Mar 24, 2023
Last update
Apr 27, 2023

Study contacts

Sara Esmat, BDS
principal investigator · Alexandria University, Faculty of Dentistry

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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