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Completed

NCT Number: NCT05283668

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

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.

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Key information

Conditions

Gingival Pigmentation

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry Ain Shams University

Cairo, 1156, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

i-PRF

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

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.

Primary outcomes

  1. Dummet oral pigmentation index

    Time frame: 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]

  2. Clinical wound healing

    Time frame: 1 week

    scored as follows:

    • Complete reepithelialization, 2) Incomplete reepithelialization, 3) ulcer and 4) tissue defect or necrosis

Secondary outcomes

  1. Satisfaction questionnaire

    Time frame: 1month

    score the degree of satisfaction about cosmetic outcomes of treatment

  2. Visual analogue scale (VAS) score for pain assessment

    Time frame: 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)

  3. Histological assessment

    Time frame: 1 week

    The mean of epithelial thickness for each case was calculated

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2022
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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