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)

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.

Study Overview

• Status: Completed
• Conditions: Gingival Pigmentation
• Intervention / Treatment: Biological: i-PRF; Procedure: Diode Laser

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 1156
    • Faculty of Dentistry Ain Shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: (LASER WITH I-PRF); Eight sites that were treated with laser method for gingival depigmentation, followed by intra-mucosal field injection of I-PRF	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.
ACTIVE_COMPARATOR: (LASER WITHOUT I-PRF); Eight sites that were treated with laser technique for gingival depigmentation only	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dummet oral pigmentation index	the degree of gingival pigmentation will be scored as: 0 = pink tissue [no clinical pigmentation]; 1 = mild light brown tissue [mild clinical pigmentation]; 2 = medium brown or mixed brown and pink tissue [moderate clinical pigmentation]; or 3 = deep brown/ blue-black tissue [heavy clinical pigmentation]	1 month
Clinical wound healing	scored as follows: 1) Complete reepithelialization, 2) Incomplete reepithelialization, 3) ulcer and 4) tissue defect or necrosis	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction questionnaire	score the degree of satisfaction about cosmetic outcomes of treatment	1month
Visual analogue scale (VAS) score for pain assessment	Pain assessment will be performed using a 10-cm (100 mm) horizontal continuous scale marked "no pain" on the left and "maximum pain" on the right side of the scale. The scores were as follows: no pain (0), slight pain (0.1-3.0 mm), moderate pain (3.1-6.0 mm), and severe pain (6.1-10 mm)	1month
Histological assessment	The mean of epithelial thickness for each case was calculated	1 week

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Ola Ezzatt, Cairo university

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2020
• Primary Completion (ACTUAL): January 20, 2022
• Study Completion (ACTUAL): January 30, 2022

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (ACTUAL): March 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation
• Other Study ID Numbers: FD-ASU -2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Available on request at principle investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No