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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05283668

Collaborator

(none)

Enrollment

Location

Arms

23.3

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of the present study are to:

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

Condition or Disease	Intervention/Treatment	Phase
Gingival Pigmentation	Biological: i-PRF Procedure: Diode Laser	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Feb 20, 2020

Actual Primary Completion Date :

Jan 20, 2022

Actual Study Completion Date :

Jan 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Dummet oral pigmentation index [1 month]
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]
Clinical wound healing [1 week]
scored as follows: 1) Complete reepithelialization, 2) Incomplete reepithelialization, 3) ulcer and 4) tissue defect or necrosis

Secondary Outcome Measures

Satisfaction questionnaire [1month]
score the degree of satisfaction about cosmetic outcomes of treatment
Visual analogue scale (VAS) score for pain assessment [1month]
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)
Histological assessment [1 week]
The mean of epithelial thickness for each case was calculated

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry Ain Shams University	Cairo		Egypt	1156

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Ola Ezzatt, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ola Mohamed Ezzatt, Associate Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05283668

Other Study ID Numbers:

FD-ASU -2021

First Posted:

Mar 17, 2022

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypopigmentation

Study Results

No Results Posted as of Mar 17, 2022