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Completed

NCT Number: NCT04758702

The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.

A Randomized, Three Parallel Arms Clinical Trial to evaluate s the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site.

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Key information

Conditions

Lack of Keratinized Gingiva

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site by comparing the percentage of re-epithelization of the palatal donor site at 5, 10, 14 and 21 days using a standardized intraoral palatal photo.

The secondary objective is to compare the post op discomfort between the three groups during the healing period daily for 2 weeks using the Visual Analogue Scale (VAS) and Analgesic consumption.

All subjects from the University of Kentucky College of Dentistry clinics. Subjects that are coming increasing the width of keratinized tissue or for the treatment of gingival recession, and match the inclusion criteria will be told about the research and offered the opportunity to participate.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects between 18-65 years of age.
  • Subjects need FGG or de-epithelialized Connective tissue graft
  • Good oral hygiene (Plaque and bleeding indexes <20%).
  • Subjects can withstand alginate impression or wear a retainer.
  • No other surgery or need for analgesics at the same site.

Exclusion criteria

  • Subjects with any systemic disorders that might compromise wound healing (Uncontrolled diabetes mellitus, rheumatoid arthritis, osteoporosis, chemotherapy/radiotherapy and immunological disorders).
  • Smokers
  • Patients not maintaining oral hygiene (plaque score >20%)
  • Pregnant or breastfeeding females.
  • Inability to provide informed consent.
  • Grafts thickness more than 2mm will be excluded from the study.

Treatment and study plan

L-PRF (Leucocyte- platelet rich fibrin)

Biological

Leucocyte-Platelet rich fibrin is a high density fibrin clot. it serves as a biological healing matrix by supporting cell migration and cytokine release, expanding the range of its potential applications greatly. Patient's own blood is centrifuged using (Intra-spin) FDA approved centrifuge on 45 degrees angle on 2700 rpm for 12 minutes.

H-PRF (Horizontal -platelet rich fibrin)

Biological

Platelet rich fibrin is a high density fibrin clot. it serves as a biological healing matrix by supporting cell migration and cytokine release, expanding the range of its potential applications greatly.Horizontally centrifuged platelet rich fibrin using (Bio-prf) centrifuge on 700 g force for 8 minutes. On a horizontal centrifugation, the cells separate much more efficiently throughout the entire membrane. This leads to better layer separation and also favors cells that are evenly distributed throughout the PRF clot.

Surgical stent

Device

An essix surgical stent will be obtained using a high vacuum suction and used to protect the denuded donor site after suturing the wound. (Biostar® Scan/Biostar®V) will be used to make the stent.

Other names: Essix retainer

Primary outcomes

  1. The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.

    Time frame: 5 days

    The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.

  2. The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.

    Time frame: 10 days

    The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.

  3. The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.

    Time frame: 14 days

    The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.

  4. The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.

    Time frame: 21 days

    The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.

Secondary outcomes

  1. The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.

    Time frame: 5 days

    The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.

  2. The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.

    Time frame: 10 days

    The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.

  3. The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.

    Time frame: 14 days

    The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.

  4. The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.

    Time frame: 21 days

    The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.

Sponsors and collaborators

Lead sponsor

Abdo Y Ismail

Other

Registry information

Official study title

The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing: A Randomized, Three Parallel Arms Clinical Trial.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2021
Registry last updated
May 31, 2023

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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