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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Wound Healing

Clinical Trials on Concentrated Growth Factor (CGF)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings