Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation
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|ClinicalTrials.gov Identifier: NCT03252418|
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gingival Hyperpigmentaion||Drug: Ascorbic Acid 500 MG Device: diode laser||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|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|
|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|
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
- 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
- patient satisfaction questionnaire [ Time Frame: immediate postopearive, 1 week, 1 month and 6 months ]from scoring patients pain and cosmetic changes
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
|Study Director:||Nevine H kheir ElDien, Professor||faculty of Dentistry- Ain Shams univesity|