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Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03252418
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Dalia Yosri, Ain Shams University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gingival Hyperpigmentaion Drug: Ascorbic Acid 500 MG Device: diode laser Phase 4

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: treating of gingival hyperpigmentation by two different methods
Masking: Single (Outcomes Assessor)
Masking Description: when measuring the gingival brightness and MAF of melanosomes
Primary Purpose: Treatment
Official Title: Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation: Histological and Clinical Randomized Study
Actual Study Start Date : October 7, 2015
Actual Primary Completion Date : September 10, 2016
Actual Study Completion Date : September 10, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arms and Interventions
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Arm Intervention/treatment
Experimental: ascorbic acid
injection of 1 ml intamucosal ascorbic acid 3 times with 1 week interval
 Drug: Ascorbic Acid 500 MG
ascorbic acid is vitamin that can cause gingival depigmentation
Experimental: diode laser
photothermolysis by diode laser in one session
 Device: diode laser
diode laser is soft tissue laser case photothermolysis of melanoctes


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. patient satisfaction questionnaire [ Time Frame: immediate postopearive, 1 week, 1 month and 6 months ]
    from scoring patients pain and cosmetic changes


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252418


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Nevine H kheir ElDien, Professor faculty of Dentistry- Ain Shams univesity
More Information
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Responsible Party: Dalia Yosri, Assistant lecturer of oral medicine and periodontology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03252418    
Other Study ID Numbers: FDASU-RECIM10201512
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dalia Yosri, Ain Shams University:
ascorbic acid
diode laser
gingival hyperpigmentation
Additional relevant MeSH terms:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Ascorbic Acid
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients