NCT04495205

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

July 21, 2020

Last Update Submit

July 28, 2020

Conditions

Gingival Pigmentation

Outcome Measures

Primary Outcomes (3)

  • Post-operative pain

    Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)

    1st day post-operative

  • Post-operative pain

    Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)

    3rd day post-operative

  • Post-operative pain

    Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)

    5th day post-operative

Secondary Outcomes (4)

  • Re-epithelization

    5th day post-operative

  • Wound healing

    3rd day post-operative

  • Wound healing

    5th day post-operative

  • Re-pigmentation

    6 months post-operative

Study Arms (2)

Non-eugenol containing periodontal packs with PRF

EXPERIMENTAL

Non-eugenol containing periodontal packs with PRF after gingival de-pigmentation

Biological: PRF under non-eugenol containing periodontal pack

Non-eugenol containing periodontal packs

PLACEBO COMPARATOR

Non-eugenol containing periodontal packs after gingival de-pigmentation

Other: Non-eugenol containing periodontal pack

Interventions

PRF under non-eugenol containing periodontal packBIOLOGICAL

Platelet Rich Fibrin under non-eugenol containing periodontal pack

Also known as: Platelet Rich Fibrin
Non-eugenol containing periodontal packs with PRF
Non-eugenol containing periodontal packOTHER

Non-eugenol containing periodontal pack after gingival depigmentation

Non-eugenol containing periodontal packs

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages18-40 years old
  • Systemically healthy
  • Mild to moderate gingival pigmentations
  • Gingival and plaque index \<1
  • Good oral hygiene
  • Thick gingival biotypes
  • Keratinized gingiva \>2mm

You may not qualify if:

  • Smokers
  • Taking any medications that could affect healing
  • Pervious depigmentation procedures
  • Pregnant or lactating females
  • Pervious periodontal surgery within the last 6 months before the start of the trial
  • Endodontically treated teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Faculty of Dentistry

Cairo, Egypt

RECRUITING

Related 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.

    PMID: 31367132BACKGROUND

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and the statistician are masked
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Masters Student

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 31, 2020

Study Start

January 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)