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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Gingival Pigmentation

Treatments: Biological: i-PRF; Procedure: Diode Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05283668

FD-ASU -2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male and female with age range from 16 to 45 years old.
• Systemically free from any disease as evidenced by the health questionnaire guided by modified Cornell medical index (Pendleton et al., 2004).
• Gingival hyperpigmentation on maxillary and mandibular labial keratinized gingiva score 3 (Dummett et al., 1964).
• Patient with thick gingival phenotype (>1.5mm) (Claffey and Shanley, 1986).

Exclusion Criteria

• Pregnant and lactating women.
• Smokers.
• Gingival pigmentation associated with occupational Hazards.
• Patients with missing anterior teeth.
• Patients with any metallic restoration related to anterior teeth or undergoing orthodontic treatment.
• Vulnerable groups (prisoners, handicapped and orphans).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

(LASER WITH I-PRF)

Experimental group

Description:

Eight sites that were treated with laser method for gingival depigmentation, followed by intra-mucosal field injection of I-PRF

Treatment:

Procedure: Diode Laser

Biological: i-PRF

(LASER WITHOUT I-PRF)

Active Comparator group

Description:

Eight sites that were treated with laser technique for gingival depigmentation only

Treatment:

Procedure: Diode Laser