Effects of CGF and Collagen Fleece on Palatal Donor Site Healing: A Randomized Clinical Trial (PAL-HEAL)

January 26, 2026 updated by: Cuneyt Asim Aral, Inonu University

Improving Palatal Donor Site Healing and Reducing Postoperative Morbidity With Concentrated Growth Factor and Collagen Fleece: Randomized Controlled Clinical Study

This study investigated whether applying Concentrated Growth Factor (CGF) or Collagen Fleece (CF) to the palatal donor site after autogenous soft tissue graft harvesting could improve wound healing and reduce postoperative discomfort. The palatal donor site often requires several weeks to heal, and patients may experience pain, delayed epithelialization, and difficulty in daily oral functions. Biologically active materials such as CGF and collagen-based dressings may help accelerate tissue repair and improve patient comfort.

A total of 38 systemically healthy adults requiring soft tissue graft harvesting were enrolled and assigned to three groups: CGF, CF, or control. In all groups, the applied material was stabilized with sutures and covered with an oral wound dressing. Palatal tissue thickness was measured at baseline and at 1, 3, and 6 months. Wound healing was evaluated on postoperative days 3, 7, and 14 and at 1 month using standardized clinical indices. Patient-reported outcomes, including pain, analgesic use, and oral health-related quality of life, were also recorded.

The study aims to determine whether CGF or CF provides superior healing, better preservation of palatal tissue thickness, and reduced postoperative morbidity compared with spontaneous healing. Findings from this trial may help clinicians select supportive materials that enhance donor-site healing and improve patient comfort after periodontal soft tissue graft procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Autogenous soft tissue grafts harvested from the palatal mucosa remain the gold standard for increasing keratinized tissue width and augmenting gingival thickness in periodontal and peri-implant plastic surgery. Despite their predictable clinical benefits, palatal donor sites frequently exhibit delayed epithelialization, postoperative bleeding, pain, and functional discomfort. These factors contribute to increased morbidity and may negatively affect patient compliance and overall satisfaction with periodontal treatment.

Recent biomaterials such as Concentrated Growth Factor (CGF) and collagen-based dressings have been proposed to enhance soft tissue regeneration and accelerate wound healing. CGF is produced by centrifugation of autologous blood and contains a dense fibrin matrix enriched with platelets, leukocytes, and growth factors. Its biological profile has been associated with improved angiogenesis, fibroblast migration, and soft-tissue remodeling. Collagen fleece (CF), a widely used resorbable matrix, provides hemostasis, a physical barrier for wound protection, and a scaffold that supports early epithelial migration. However, the comparative clinical efficacy of CGF and CF on palatal donor site healing has not been clearly established in controlled human studies.

This randomized controlled clinical trial was designed to evaluate the effects of CGF and CF on wound healing dynamics, preservation of palatal tissue thickness, and postoperative morbidity following standardized soft tissue graft harvesting. Thirty-eight systemically healthy adult patients requiring autogenous grafts were included and allocated to one of three groups: CGF, CF, or control. In the test groups, either CGF or CF was applied to the donor site, stabilized with sutures, and covered with an oral wound dressing. In the control group, a collagen sponge was placed beneath the wound dressing. All groups received identical postoperative care.

Primary and secondary outcome measures included changes in palatal tissue thickness, wound healing scores, epithelialization patterns, patient-reported pain levels, analgesic consumption, bleeding, and oral health-related quality of life. Tissue thickness was evaluated at baseline and at 1, 3, and 6 months postoperatively. Wound healing characteristics were recorded on postoperative days 3, 7, and 14, and at 1 month, using standardized indices such as the H₂O₂ bubbling test, the Modified Manchester Scar Scale, and the Landry-Turnbull-Howley healing index. Pain intensity and functional discomfort were assessed using visual analog scales (VAS), while overall patient impact was measured with the OHIP-14 questionnaire.

The central hypothesis of this study was that both CGF and CF would enhance palatal donor site healing relative to spontaneous healing, and that CGF would demonstrate additional benefits due to its autologous biological activity. The findings of this trial are expected to provide clinicians with evidence-based guidance on the use of supportive biomaterials to reduce postoperative morbidity, improve patient comfort, and optimize regenerative outcomes after periodontal soft-tissue grafting procedures.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Malatya, Turkey (Türkiye), 44000
        • Inönü University Faculty of Dentistry, Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥18 years
  • Systemically healthy individuals
  • Good oral hygiene
  • Stable periodontal condition
  • Indication for mucogingival surgery requiring autogenous soft tissue grafting
  • Free gingival graft or de-epithelialized free gingival graft combined with either a coronally advanced flap or tunnel technique

Exclusion Criteria:

  • Smoking
  • Pregnancy or lactation
  • Systemic diseases affecting wound healing
  • Use of medications known to interfere with healing
  • History of radiotherapy or chemotherapy
  • Poor oral hygiene or uncontrolled periodontal disease
  • Concomitant bone surgery or implant placement
  • Surgical duration exceeding 2 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concentrated Growth Factor (CGF)
Biological: Concentrated Growth Factor (CGF)
A CGF membrane prepared from the participant's venous blood was applied to the palatal donor site following soft tissue graft harvesting. The membrane was stabilized using sutures and covered with an oral wound dressing to support healing and reduce postoperative morbidity.
Experimental: Collagen Fleece (CF)
Biological: Collagen Fleece (CF)
A collagen fleece was placed over the palatal donor site immediately after tissue harvesting. The material was stabilized with sutures and covered with an oral wound dressing to promote donor site healing.
Experimental: Control (Collagen Sponge)
Biological: Collagen Sponge (Control)
A sterile collagen sponge was applied to the palatal donor site as the control intervention. The sponge was secured with sutures and covered with an oral wound dressing, serving as the standard healing approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Palatal Tissue Thickness at the Donor Site
Time Frame: Baseline, 1 month, 3 months, and 6 months postoperatively
Palatal tissue thickness at the donor site was measured using a standardized periodontal probe and/or caliper at baseline and during follow-up. Changes in thickness were compared among the CGF, CF, and control groups to assess the effectiveness of each intervention in maintaining palatal tissue thickness.
Baseline, 1 month, 3 months, and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-epithelialization Assessed by H₂O₂ Bubbling Test
Time Frame: Postoperative Day 3, Day 7, Day 14, and 1 Month
Re-epithelialization of the palatal donor site was evaluated using the hydrogen peroxide (H₂O₂) bubbling test. The presence or absence of bubbling indicated incomplete or complete epithelial coverage. Healing progression was compared among the three groups.
Postoperative Day 3, Day 7, Day 14, and 1 Month
Analgesic Consumption
Time Frame: First 7 Days Postoperatively
The total number of analgesic tablets consumed by each participant during the postoperative period was recorded to assess the need for pain control. Lower consumption indicates reduced postoperative morbidity.
First 7 Days Postoperatively
Wound Healing Quality - Landry-Turnbull-Howley (LTH) Index
Time Frame: Postoperative Day 7, Day 14, and 1 Month

Wound healing at the palatal donor site was assessed using the Landry-Turnbull-Howley (LTH) Wound Healing Index, a clinician-rated ordinal scale evaluating overall soft tissue healing based on tissue color, bleeding on palpation, presence of granulation tissue, epithelialization of the incision margin, and suppuration.

Healing is scored on a 5-point scale ranging from 1 to 5, where:

  1. = very poor,
  2. = poor,
  3. = good,
  4. = very good,
  5. = excellent.

The total score therefore ranges from 1 (worst healing) to 5 (best healing), with higher scores indicating better wound healing and more favorable clinical outcomes.
Postoperative Day 7, Day 14, and 1 Month
Scar Formation - Modified Manchester Scar Scale (MSS)
Time Frame: Postoperative Day 7, Day 14, and 1 Month
Scar appearance at the palatal donor site was evaluated using the Modified Manchester Scar Scale (MSS), a clinician-rated scale assessing color, contour, and distortion. Each parameter is scored from 0 to 2 (0 = normal/best appearance, 2 = marked discrepancy/worst appearance), resulting in a total score range of 0-6. Lower scores indicate better scar quality and more favorable healing, whereas higher scores indicate poorer scar appearance. Assessments were performed at 1 and 3 months postoperatively.
Postoperative Day 7, Day 14, and 1 Month
Postoperative Pain - Visual Analog Scale (VAS)
Time Frame: Postoperative Day 1, Day 3, Day 7, Day 14
Postoperative pain intensity was assessed using the Visual Analog Scale (VAS), a validated self-reported measure of subjective pain. Patients rated their pain on a 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores therefore represent greater pain severity and worse clinical outcomes. Pain scores were recorded at predefined postoperative intervals to monitor changes in pain intensity over time.
Postoperative Day 1, Day 3, Day 7, Day 14
Patient-Reported Oral Health-Related Quality of Life (OHIP-14)
Time Frame: Assessments were performed on postoperative days 3, 7 and 14.

Oral health-related quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14), a validated patient-reported questionnaire consisting of 14 items across seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.

Each item is scored on a 5-point Likert scale (0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often). The total score ranges from 0 to 56, with higher scores indicating worse oral health-related quality of life and greater functional impairment, whereas lower scores reflect better patient-reported outcomes.
Assessments were performed on postoperative days 3, 7 and 14.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

January 16, 2026

Study Completion (Actual)

January 16, 2026

Study Registration Dates

First Submitted

January 17, 2026

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUCREC.2023.82
  • TDH-2024-3515 (Other Grant/Funding Number: Inönü University Scientific Research Projects Coordination Office)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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