Clinical trial NCT04758702: The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lack of Keratinized Gingiva
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
timeFrame: 5 days
measure: The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
timeFrame: 10 days
measure: The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
timeFrame: 14 days
measure: The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
timeFrame: 21 days
Secondary outcomes:
measure: The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
timeFrame: 5 days
measure: The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
timeFrame: 10 days
measure: The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
timeFrame: 14 days
measure: The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
timeFrame: 21 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Mohanad Al-Sabbagh, DDS, MS
role: STUDY_CHAIR
References: