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

Gingival Pigmentation Clinical Trial

Official title:

The Adjunctive Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation (A Randomized Clinical Trial With Histological Analysis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283668
• Other study ID #: FD-ASU -2021
• Status: Completed
• Phase: Phase 4
• Start date: February 20, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: March 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 30, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gingival Pigmentation
• Hypopigmentation

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Clinical wound healing	scored as follows: 1) Complete reepithelialization, 2) Incomplete reepithelialization, 3) ulcer and 4) tissue defect or necrosis	1 week
Secondary	Satisfaction questionnaire	score the degree of satisfaction about cosmetic outcomes of treatment	1month
Secondary	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
Secondary	Histological assessment	The mean of epithelial thickness for each case was calculated	1 week