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Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation

Primary Purpose

Gingival Hyperpigmentaion

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ascorbic Acid 500 MG
diode laser
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Hyperpigmentaion focused on measuring ascorbic acid, diode laser, gingival hyperpigmentation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    ascorbic acid

    diode laser

    Arm Description

    injection of 1 ml intamucosal ascorbic acid 3 times with 1 week interval

    photothermolysis by diode laser in one session

    Outcomes

    Primary Outcome Measures

    Dummett oral pigmentaion index (DOPI)
    scoring from 0 ( no pigmentation to 3 (sever pigmentation
    gingival brightness (ΔL)
    using spectrophotometer
    histological mean area fraction of melanosomes
    by taking soft tissue samples and stained by fontana masson stain

    Secondary Outcome Measures

    patient satisfaction questionnaire
    from scoring patients pain and cosmetic changes

    Full Information

    First Posted
    August 15, 2017
    Last Updated
    August 18, 2017
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03252418
    Brief Title
    Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation
    Official Title
    Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation: Histological and Clinical Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 7, 2015 (Actual)
    Primary Completion Date
    September 10, 2016 (Actual)
    Study Completion Date
    September 10, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Hyperpigmentaion
    Keywords
    ascorbic acid, diode laser, gingival hyperpigmentation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    treating of gingival hyperpigmentation by two different methods
    Masking
    Outcomes Assessor
    Masking Description
    when measuring the gingival brightness and MAF of melanosomes
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ascorbic acid
    Arm Type
    Experimental
    Arm Description
    injection of 1 ml intamucosal ascorbic acid 3 times with 1 week interval
    Arm Title
    diode laser
    Arm Type
    Experimental
    Arm Description
    photothermolysis by diode laser in one session
    Intervention Type
    Drug
    Intervention Name(s)
    Ascorbic Acid 500 MG
    Intervention Description
    ascorbic acid is vitamin that can cause gingival depigmentation
    Intervention Type
    Device
    Intervention Name(s)
    diode laser
    Intervention Description
    diode laser is soft tissue laser case photothermolysis of melanoctes
    Primary Outcome Measure Information:
    Title
    Dummett oral pigmentaion index (DOPI)
    Description
    scoring from 0 ( no pigmentation to 3 (sever pigmentation
    Time Frame
    change from baseline to 1, 3 and 6 months
    Title
    gingival brightness (ΔL)
    Description
    using spectrophotometer
    Time Frame
    change from baseline to 1, 3 and 6 months
    Title
    histological mean area fraction of melanosomes
    Description
    by taking soft tissue samples and stained by fontana masson stain
    Time Frame
    change from baseline to 6 months
    Secondary Outcome Measure Information:
    Title
    patient satisfaction questionnaire
    Description
    from scoring patients pain and cosmetic changes
    Time Frame
    immediate postopearive, 1 week, 1 month and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nevine H kheir ElDien, Professor
    Organizational Affiliation
    faculty of Dentistry- Ain Shams univesity
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation

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