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

NCT ID: NCT04758702

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-24
• Study Completion Date: 2023-05-25

Brief Summary

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.

Detailed Description

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.

Conditions

Lack of Keratinized Gingiva

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

GROUP 1

L-PRF membranes will be placed on the palatal donor site to help stabilizing the blood clot and release of growth factors that help in deceasing the discomfort wound healing.

Group Type: EXPERIMENTAL

L-PRF (Leucocyte- platelet rich fibrin)

Intervention Type: 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.

GROUP 2

H-PRF membranes will be placed on the palatal donor site to help stabilizing the blood clot and release of growth factors that help in deceasing the discomfort wound healing.

Group Type: EXPERIMENTAL

H-PRF (Horizontal -platelet rich fibrin)

Intervention Type: 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.

GROUP 3

A surgical stent will be delivered to cover the surgical site and apply pressure on the wound site.

Group Type: EXPERIMENTAL

Surgical stent

Intervention Type: 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.

Interventions

L-PRF (Leucocyte- platelet rich fibrin)

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.

Intervention Type: BIOLOGICAL

H-PRF (Horizontal -platelet rich fibrin)

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.

Intervention Type: BIOLOGICAL

Surgical stent

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.

Intervention Type: DEVICE

Other Intervention Names

Essix retainer

Eligibility Criteria

Inclusion Criteria

1. Subjects between 18-65 years of age.

2. Subjects need FGG or de-epithelialized Connective tissue graft

3. Good oral hygiene (Plaque and bleeding indexes <20%).

4. Subjects can withstand alginate impression or wear a retainer.

5. No other surgery or need for analgesics at the same site.

Exclusion Criteria

1. Subjects with any systemic disorders that might compromise wound healing (Uncontrolled diabetes mellitus, rheumatoid arthritis, osteoporosis, chemotherapy/radiotherapy and immunological disorders).

2. Smokers

3. Patients not maintaining oral hygiene (plaque score >20%)

4. Pregnant or breastfeeding females.

5. Inability to provide informed consent.

6. Grafts thickness more than 2mm will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abdo Y Ismail

OTHER

Sponsor Role: lead

Responsible Party

Abdo Y Ismail

Post-graduate Periodontics Resident

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mohanad Al-Sabbagh, DDS, MS

Role: STUDY_CHAIR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

63364

Identifier Type: -

Identifier Source: org_study_id