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