Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-31 @ 8:05 AM
Study NCT ID:
NCT05283668
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2022-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
The Adjunctive Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation (A Randomized Clinical Trial With Histological Analysis)
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of the present study are to:
1. Evaluate the effect of I-PRF injection following laser gingival depigmentation technique on the healing period as a primary objective.
2. Assess patient satisfaction following the procedure in terms of pain and esthetic outcome as a secondary objective.
1. Evaluate the effect of I-PRF injection following laser gingival depigmentation technique on the healing period as a primary objective.
2. Assess patient satisfaction following the procedure in terms of pain and esthetic outcome as a secondary objective.
Detailed Description:
Dental esthetic needs are increasing in recent years with a greater demand on pleasant appearance; including a healthy set of dentitions but also esthetically improved gingival appearance, especially when it is located in the anterior labial region. Physiologic gingival hyperpigmentation affects numerous people of different ethnic backgrounds.
Gingival depigmentation is defined as a periodontal plastic surgical procedure that are aimed at removing the pigmented gingiva and methods aimed at masking the pigmented gingiva. Techniques of gingival depigmentation can be classified as; chemical methods mainly by ascorbic acids, surgical methods, electrosurgery, cryosurgery, radiosurgery, and lasers.
The study was conducted on eight patients seeking treatment for their gingival hyperpigmentation for esthetic reasons. A total number of 16 sites of facial gingival hyperpigmentation were treated, two in each patient in a split mouth technique.
* Group I (LASER with I-PRF): Included eight sites that were treated with laser technique for gingival depigmentation, followed by intramucosal field injection of I-PRF (as study group).
* Group II (LASER): Included eight sites that were treated with laser technique for gingival depigmentation (as a control group).
The clinical outcomes were assessed for each patient: at baseline (pre-operative), post-operative, one week, one month. Clinical assessment was done by measuring DOPI, clinical wound healing, VAS and patient satisfaction questionnaire.
Gingival depigmentation is defined as a periodontal plastic surgical procedure that are aimed at removing the pigmented gingiva and methods aimed at masking the pigmented gingiva. Techniques of gingival depigmentation can be classified as; chemical methods mainly by ascorbic acids, surgical methods, electrosurgery, cryosurgery, radiosurgery, and lasers.
The study was conducted on eight patients seeking treatment for their gingival hyperpigmentation for esthetic reasons. A total number of 16 sites of facial gingival hyperpigmentation were treated, two in each patient in a split mouth technique.
* Group I (LASER with I-PRF): Included eight sites that were treated with laser technique for gingival depigmentation, followed by intramucosal field injection of I-PRF (as study group).
* Group II (LASER): Included eight sites that were treated with laser technique for gingival depigmentation (as a control group).
The clinical outcomes were assessed for each patient: at baseline (pre-operative), post-operative, one week, one month. Clinical assessment was done by measuring DOPI, clinical wound healing, VAS and patient satisfaction questionnaire.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: