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

NCT ID: NCT05283668

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2022-01-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

(LASER WITH I-PRF)

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

Group Type: EXPERIMENTAL

i-PRF

Intervention Type: 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.

Diode Laser

Intervention Type: 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 WITHOUT I-PRF)

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

Group Type: ACTIVE_COMPARATOR

Diode Laser

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: PROCEDURE

Eligibility 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).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ola Mohamed Ezzatt

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ola Ezzatt

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Dentistry Ain Shams University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 38536994 (View on PubMed)

Other Identifiers

FD-ASU -2021

Identifier Type: -

Identifier Source: org_study_id