Clinical trial NCT05283668: Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingival Pigmentation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Dummet oral pigmentation index
timeFrame: 1 month
measure: Clinical wound healing
timeFrame: 1 week
Secondary outcomes:
measure: Satisfaction questionnaire
timeFrame: 1month
measure: Visual analogue scale (VAS) score for pain assessment
timeFrame: 1month
measure: Histological assessment
timeFrame: 1 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ain Shams University
Study officials:
affiliation: Cairo University
name: Ola Ezzatt
role: PRINCIPAL_INVESTIGATOR
References: