NCT03719274

Brief Summary

Although physiologic gingival hyperpigmentation is not a pathologic condition, it is considered one of the main esthetic problems in dentistry. It was found that the attached gingiva is the most frequently pigmented intraoral tissues followed by the papillary gingiva and the alveolar mucosa

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

October 22, 2018

Last Update Submit

October 23, 2018

Conditions

Melanin Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

  • gingival color change

    the degree of gingival color is determined by 2 different color indices

    6 months

Study Arms (2)

non-surgical vitamin c depigmentation

EXPERIMENTAL

locally injected vitamin c is used to depigment the hyperpigmented gingival tissues

Dietary Supplement: vitamin c depigementation

surgical depigmentation

ACTIVE COMPARATOR

the conventional scalpel surgical technique is used to depigment the hyperpigmented gingival tissues

Dietary Supplement: vitamin c depigementation

Interventions

vitamin c depigementationDIETARY_SUPPLEMENT

locally injected vitamin c depigementation

non-surgical vitamin c depigmentationsurgical depigmentation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-50 y
  • medically free;
  • physiologic gingival hyperpigmentation related to esthetic region were selected.

You may not qualify if:

  • All the reasons that could provoke an inflammatory reaction were excluded such as:
  • systemic diseases (especially auto-immune diseases and chemotherapy uptake);
  • pregnant and lactating mothers;
  • usage of chlorhexidine or povidone iodine;
  • Local causes (smoking and periodontitis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • nermin yussif

    msa university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 25, 2018

Study Start

April 1, 2016

Primary Completion

June 1, 2018

Study Completion

October 1, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10