A Phase 4 interventional study of Ascorbic Acid 500 MG and diode laser in Gingival Hyperpigmentaion, sponsored by Ain Shams University. Completed. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
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.
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.
Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
injection of 1 ml intamucosal ascorbic acid 3 times with 1 week interval
Drug: Ascorbic Acid 500 MG
photothermolysis by diode laser in one session
Device: diode laser
ascorbic acid is vitamin that can cause gingival depigmentation
diode laser is soft tissue laser case photothermolysis of melanoctes
Dummett oral pigmentaion index (DOPI)
scoring from 0 ( no pigmentation to 3 (sever pigmentation
Time frame: change from baseline to 1, 3 and 6 months
gingival brightness (ΔL)
using spectrophotometer
Time frame: change from baseline to 1, 3 and 6 months
histological mean area fraction of melanosomes
by taking soft tissue samples and stained by fontana masson stain
Time frame: change from baseline to 6 months
patient satisfaction questionnaire
from scoring patients pain and cosmetic changes
Time frame: immediate postopearive, 1 week, 1 month and 6 months
No study locations are listed for this record.
Ran from Oct 2015 to primary completion in Sep 2016, 11 months.
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ascorbic Acid