NCT07439068

Brief Summary

The objective of this study was to compare and evaluate the effects of concentrated growth factor (CGF) and advanced platelet-rich fibrin (A-PRF) clot membranes on palatal epithelial wound healing and postoperative discomfort following free gingival graft (FGG) harvesting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

February 10, 2026

Last Update Submit

February 26, 2026

Conditions

Free Gingival Graft

Keywords

Concentrated Growth FactorAdvanced Platelet-Rich Fibrin

Outcome Measures

Primary Outcomes (16)

  • Epithelialization

    Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface

    Baseline

  • Epithelialization

    Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface

    1 week post-surgery

  • Epithelialization

    Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface

    2 week post-surgery

  • Epithelialization

    Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface

    3 week post-surgery

  • Epithelialization

    Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface

    4 week post-surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    Baseline

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    1st day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    2nd day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    3th day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    4th day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    5th day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    6th day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    7th day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    14th day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    21st day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    28th day after surgery

Study Arms (3)

Advanced platelet-rich fibrin

ACTIVE COMPARATOR

Advanced platelet-rich fibrin clot membranes on palatal epithelial wound after harvesting free gingival graft

Procedure: Advanced platelet-rich fibrin

Concentrated growth factor

ACTIVE COMPARATOR

Concentrated growth factor clot membranes on palatal epithelial wound after harvesting free gingival graft

Procedure: Concentrated growth factor

Sterile gelatin sponge

PLACEBO COMPARATOR

Sterile gelatin sponge on palatal epithelial wound after harvesting free gingival graft

Procedure: Sterile gelatin sponge

Interventions

Advanced platelet-rich fibrinPROCEDURE

Advanced platelet-rich fibrin membranes and free gingival graft

Advanced platelet-rich fibrin
Concentrated growth factorPROCEDURE

Concentrated growth factor membranes and free gingival graft

Concentrated growth factor
Sterile gelatin spongePROCEDURE

Sterile gelatin sponge and free gingival graft

Sterile gelatin sponge

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • at least 18 years old,
  • without systemic or periodontal diseases,
  • without medical contraindications to periodontal surgery
  • with full-mouth plaque control scores ≤ 20%
  • Gingival index scores ≤ 1

You may not qualify if:

  • smoking habits,
  • diabetes mellitus,
  • pregnancy or lactation,
  • removable upper denture,
  • regular medication that could interpose the healing process, undergoing bisphosphonate therapy, history of radiation therapy of the jaws, and follow-up consults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52100, Turkey (Türkiye)

Location

Study Officials

  • Figen Öngöz Dede, Prof

    Ordu Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 27, 2026

Study Start

November 1, 2020

Primary Completion

May 30, 2022

Study Completion

May 31, 2022

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)