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

NCT05283668 | Completed Phase 4 DMC

• 1 other identifier: FD-ASU -2021
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the present study are to:

1. 1.Evaluate the effect of I-PRF injection following laser gingival depigmentation technique on the healing period as a primary objective.
2. 2.Assess patient satisfaction following the procedure in terms of pain and esthetic outcome as a secondary objective.

Conditions

Gingival Pigmentation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Satisfaction questionnaire

  1month

• Visual analogue scale (VAS) score for pain assessment

  1month

• Histological assessment

  1 week

Study Arms (2)

(LASER WITH I-PRF)

EXPERIMENTAL

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

Biological: i-PRF; Procedure: Diode Laser

(LASER WITHOUT I-PRF)

ACTIVE COMPARATOR

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

Procedure: Diode Laser

Interventions

i-PRF BIOLOGICAL

* 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.

(LASER WITH I-PRF)

Diode Laser PROCEDURE

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.

(LASER WITH I-PRF); (LASER WITHOUT I-PRF)

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, 1156, Egypt

Location

Related Publications (1)

• Ibrahim SSA, Mandil IA, Ezzatt OM. Injectable platelet rich fibrin effect on laser depigmented gingiva: a clinical randomized controlled split mouth trial with histological assessment. J Appl Oral Sci. 2024 Mar 25;32:e20230307. doi: 10.1590/1678-7757-2022-0307. eCollection 2024.

  PMID: 38536994 DERIVED

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Ola Ezzatt

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 17, 2022
• Study Start: February 20, 2020
• Primary Completion: January 20, 2022
• Study Completion: January 30, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)