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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04495205
Other study ID # AHReda
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 1, 2020
Est. completion date March 2021

Study information

Verified date July 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In an era where less than ideal esthetics is not accepted, the request for esthetic procedures is widely sought after. Melanin, a brown pigment, is the most common natural pigment contributing to endogenous pigmentation of gingiva. It is a non-hemoglobin-derived pigment formed by cells called melaonocytes

Dental cosmetic procedures including gingival depigmentation among the young generation are vastly becoming popular due to the public advertising of what the "ideal smile" should be. This means that brown/ pigmented gingiva is not esthetically accepted by modern standards. Numerous techniques for depigmentation were developed including surgical abrasion, lasers, chemicals and thermal techniques.

The use of post-operative non-eugenol containing periodontal packs acts as a mechanical barrier for coverage of the denuded area which prevents bleeding and promotes healing by preventing trauma to the area.

Platelet Rich Fibrin (PRF) is a form of concentrated suspension of growth factors that promote healing and tissue regeneration. Its use in the medical and dental fields is expanding during the recent year.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
PRF under non-eugenol containing periodontal pack
Platelet Rich Fibrin under non-eugenol containing periodontal pack
Other:
Non-eugenol containing periodontal pack
Non-eugenol containing periodontal pack after gingival depigmentation

Locations

Country Name City State
Egypt Cairo University Faculty of Dentistry Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Dahiya R, Blaggana A, Panwar V, Kumar S, Kathuria A, Malik S. Clinical and histological comparison of platelet-rich fibrin versus non-eugenol periodontal dressing in the treatment of gingival hyperpigmentation. J Indian Soc Periodontol. 2019 Jul-Aug;23(4):345-350. doi: 10.4103/jisp.jisp_688_18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative pain Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain) 1st day post-operative
Primary Post-operative pain Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain) 3rd day post-operative
Primary Post-operative pain Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain) 5th day post-operative
Secondary Re-epithelization Toulodine Blue test: dark blue = positive (worst score), light blue = negative (better score) 5th day post-operative
Secondary Wound healing Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent) 3rd day post-operative
Secondary Wound healing Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent) 5th day post-operative
Secondary Re-pigmentation Re-pigmentation of de pigmented site (Kumar, Bhat and Bhat, 2012): minimum score 0 (absence of depigmentation, maximum score 3 (Diffuse brown to black pigmentation, marginal, and attached) 6 months post-operative
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