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

Phase 4

Completed

• Conditions: Gingival Pigmentation
• Interventions: Biological: i-PRF; Procedure: Diode Laser

• Registration Number: NCT05283668
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2020-02-20
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-30
• Study First Submitted: 2022-02-28
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-08
• Last Update Submitted: 2022-03-08
• Study First Posted: 2022-03-17
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(LASER WITH I-PRF)	i-PRF	Eight sites that were treated with laser method for gingival depigmentation, followed by intra-mucosal field injection of I-PRF
(LASER WITH I-PRF)	Diode Laser	Eight sites that were treated with laser method for gingival depigmentation, followed by intra-mucosal field injection of I-PRF
(LASER WITHOUT I-PRF)	Diode Laser	Eight sites that were treated with laser technique for gingival depigmentation only

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Dentistry Ain Shams University; 🇪🇬 Cairo, Egypt