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NCT Number: NCT03252418

Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation

Vitamin C affect the melanocytes function not the number while diode laser cause melanocytes destruction. Although diode laser and vitamin C have proved their effectiveness in depigmentation in previous studies, there are no published studies compared the effect of diode laser and vitamin C on melanocytes and melanosomes clinically and histologically.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Cosmetic dentistry is usually centered on aesthetic restorative procedures but it may also involve the appearance of the gingiva, especially when it is located in the anterior labial region. Oral pigmentation may be physiological or pathological in nature. Better esthetics results of depigmentation were achieved with diode laser than conventional scalpel and with rotary abrasion, also diode laser is effective and safe in removal of gingival hyperpigmentation and repigmentation doesn't occur.When choosing a depigmenting agent, it is important to differentiate between substances that are toxic to the melanocyte and substances that interrupt the key steps of melanogenesis. Vit. C interacts with copper ions at the tyrosinase-active site and inhibits action of the enzyme tyrosinase, thereby decreasing the melanin formation.

This randomized comparative clinical study was conducted on ten patients attending the outpatient clinic of the Oral Medicine and Periodontology department, Faculty of Dentistry, Ain Shams University and seeking treatment for their gingival hyperpigmentation for esthetic reason.

The study was conducted after receiving an ethical clearance from the Research Ethics Committee of Ain Shams University, Faculty of Dentistry; that the study follows the ethical guidelines of research. The patients clearly understood the purpose of this study and signed an informed consent.

According to the study results, vit C treated patients showed no or little repigmentation after six months post treatment. Conversely, diode laser treated patients showed significant recurrence of gingival pigmentation after six months post treatment. These could be attributed to the blocking effect of vitamin C on the existing melanocytes to form new melanoseomes, however diode laser cause removal of the existing melanocytes that may cause formation of new melanocytes (migrating from neighboring melanocytes from the adjacent area of the gingiva) with the ability of forming new melanosomes and causing repigmentation. Histopathological assessment revealed that both treatment modalities caused significant reduction in MAF after six months post treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients with age ranging from 18 years old to 40 years old.
  • Bilaterally symmetric gingival hyperpigmentation on the maxillary and mandibular labial keratinized gingiva between canines.
  • Patients free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004).
  • Patients with thick gingival biotype ≥ 3 mm.

Exclusion criteria

  • Presence of local condition that may cause gingival hyperpigmentation (traumatized epithelium caused by defective fixed prosthesis or restoration).
  • Smokers.
  • Pregnant or lactating females.
  • Patients with poor oral hygiene, incompliance to treatment and persistence gingival inflammation after phase I periodontal therapy.
  • Clinically diagnosed periodontitis (attachment and bone loss, presence of periodontal pockets, gingival recession and tooth mobility).
  • Previous treatment to pigmentation.
  • Patients taking supplementary vitamin C for any reason.
  • Known sensitivity to ascorbic acid or any of its derivatives.
  • Patients taking any drug that may cause gingival pigmentation.

Treatment and study plan

Ascorbic Acid 500 MG

Drug

ascorbic acid is vitamin that can cause gingival depigmentation

Diode laser

Device

diode laser is soft tissue laser case photothermolysis of melanoctes

Primary outcomes

  1. Dummett oral pigmentaion index (DOPI)

    Time frame: change from baseline to 1, 3 and 6 months

    scoring from 0 ( no pigmentation to 3 (sever pigmentation

  2. gingival brightness (ΔL)

    Time frame: change from baseline to 1, 3 and 6 months

    using spectrophotometer

  3. histological mean area fraction of melanosomes

    Time frame: change from baseline to 6 months

    by taking soft tissue samples and stained by fontana masson stain

Secondary outcomes

  1. patient satisfaction questionnaire

    Time frame: immediate postopearive, 1 week, 1 month and 6 months

    from scoring patients pain and cosmetic changes

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation: Histological and Clinical Randomized Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 17, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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