Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation

August 18, 2017 updated by: Dalia Yosri, Ain Shams University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
change from baseline to 1, 3 and 6 months
gingival brightness (ΔL)
Time Frame: change from baseline to 1, 3 and 6 months
using spectrophotometer
change from baseline to 1, 3 and 6 months
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
change from baseline to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
patient satisfaction questionnaire
Time Frame: immediate postopearive, 1 week, 1 month and 6 months
from scoring patients pain and cosmetic changes
immediate postopearive, 1 week, 1 month and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nevine H kheir ElDien, Professor, faculty of Dentistry- Ain Shams univesity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FDASU-RECIM10201512

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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