NCT05283668

Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 16 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Gingival Pigmentation

Interventions

Type	Name	Description
BIOLOGICAL	i-PRF	* Local anesthesia was achieved using field block technique. * A soft tissue diode surgical laser unit was used in a contact method using a flexible fiber optic hand piece with initiated tip. * Laser irradiation parameters were adjusted as follows: Wavelength \[940 ± 10 nm\], irradiation mode \[contact continuous wave\], Power \[2 W\] and 300 μm fiber tip diameter (Jokar et al., 2019). * The treatment was depigmentation by laser thin injection by I-PRF Post-operative instructions Instruct the patients to avoid tooth brushing on the day of surgical treatment to prevent mechanical trauma and allow re-epithelialization.
PROCEDURE	Diode Laser	Local anesthesia was achieved using field block technique. * A soft tissue diode surgical laser unit was used in a contact method using a flexible fiber optic hand piece with initiated tip. * Laser irradiation parameters were adjusted as follows: Wavelength \[940 ± 10 nm\], irradiation mode \[contact continuous wave\], Power \[2 W\] and 300 μm fiber tip diameter (Jokar et al., 2019). Post-operative instructions Instruct the patients to avoid tooth brushing on the day of surgical treatment to prevent mechanical trauma and allow re-epithelialization.

Timeline

• Start date: 2020-02-20
• Primary completion: 2022-01-20
• Completion: 2022-01-30
• First posted: 2022-03-17
• Last updated: 2022-03-17

Locations

1 site across 1 country: Egypt