Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation

• ClinicalTrials.gov Identifier: NCT03252418
• Recruitment Status: Completed
• First Posted: August 17, 2017
• Last Update Posted: August 22, 2017
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Dalia Yosri, Ain Shams University

Tracking Information

• First Submitted Date: August 15, 2017
• First Posted Date: August 17, 2017
• Last Update Posted Date: August 22, 2017
• Actual Study Start Date: October 7, 2015
• Actual Primary Completion Date: September 10, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2017)

• 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
• gingival brightness (ΔL) [ Time Frame: change from baseline to 1, 3 and 6 months ]
  using spectrophotometer
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 15, 2017)

patient satisfaction questionnaire [ Time Frame: immediate postopearive, 1 week, 1 month and 6 months ]

from scoring patients pain and cosmetic changes

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 4

Study Design

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

• Condition: Gingival Hyperpigmentaion

Intervention

• Drug: Ascorbic Acid 500 MG
  ascorbic acid is vitamin that can cause gingival depigmentation
• Device: diode laser
  diode laser is soft tissue laser case photothermolysis of melanoctes

Study Arms

• Experimental: ascorbic acid
  injection of 1 ml intamucosal ascorbic acid 3 times with 1 week interval
  Intervention: Drug: Ascorbic Acid 500 MG
• Experimental: diode laser
  photothermolysis by diode laser in one session
  Intervention: Device: diode laser

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 15, 2017): 10
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 10, 2016
• Actual Primary Completion Date: September 10, 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03252418
• Other Study ID Numbers: FDASU-RECIM10201512
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dalia Yosri, Ain Shams University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ain Shams University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Nevine H kheir ElDien, Professor; faculty of Dentistry- Ain Shams univesity

• PRS Account: Ain Shams University
• Verification Date: August 2017