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Wound HealingPAL-HEALNCT07367165

Effects of CGF and Collagen Fleece on Palatal Donor Site Healing: A Randomized Clinical Trial

A study testing Concentrated Growth Factor (CGF) and Collagen Fleece (CF) in people with Wound Healing, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Wound Healing
What is being tested?
Concentrated Growth Factor (CGF) and Collagen Fleece (CF)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2023to 16 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Inönü University Faculty of Dentistry, Department of Periodontology

    Malatya, 44000

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Wound Healing
Being tested
Concentrated Growth Factor (CGF), Collagen Fleece (CF), Collagen Sponge (Control)
Keywords
Concentrated Growth Factor (CGF), Collagen Fleece, Palatal Donor Site, Soft Tissue Graft Harvesting, Wound Healing, Oral Soft Tissue Regeneration, Postoperative Morbidity, Gingival Thickness, Periodontal Plastic Surgery, Autogenous Graft

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Concentrated Growth Factor (CGF)Biological

    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.

  • Collagen Fleece (CF)Biological

    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.

  • Collagen Sponge (Control)Biological

    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.

Study groups in NCT07367165
Study groupRoleWhat they receive
Concentrated Growth Factor (CGF)ExperimentalNot described
Receives: Biological: Concentrated Growth Factor (CGF)
Collagen Fleece (CF)ExperimentalNot described
Receives: Biological: Collagen Fleece (CF)
Control (Collagen Sponge)ExperimentalNot described
Receives: Biological: Collagen Sponge (Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wound Area at the Donor Site

    The wound margins were manually delineated using the freehand selection tool in ImageJ software to define the region of interest, and the enclosed area was automatically calculated. Calibration was performed using a periodontal probe to convert pixel values into millimeters, enabling standardized and objective measurements.

    Measured: Wound Area at Postoperative Day 7

Secondary outcomes (8)
  1. Re-epithelialization Assessed by H₂O₂ Bubbling Test

    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.

    Measured: Postoperative Day 3, Day 7, Day 14, and 1 Month

  2. Change in Palatal Tissue Thickness at the Donor Site

    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.

    Measured: Baseline, 1 month, 3 months, and 6 months postoperatively

  3. Wound Healing Quality - Landry-Turnbull-Howley (LTH) Index

    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.

    Measured: Postoperative Day 7, Day 14, and 1 Month

  4. Scar Formation - Modified Manchester Scar Scale (MSS)

    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.

    Measured: Postoperative Day 7, Day 14, and 1 Month

  5. Postoperative Pain - Visual Analog Scale (VAS)

    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.

    Measured: Postoperative Day 1, Day 3, Day 7, Day 14

  6. Analgesic Consumption

    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.

    Measured: First 7 Days Postoperatively

  7. Patient-Reported Oral Health-Related Quality of Life (OHIP-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.

    Measured: Assessments were performed on postoperative days 3, 7 and 14.

  8. Wound Area at the Donor Site

    The wound margins were manually delineated using the freehand selection tool in ImageJ software to define the region of interest, and the enclosed area was automatically calculated. Calibration was performed using a periodontal probe to convert pixel values into millimeters, enabling standardized and objective measurements.

    Measured: Wound Area at 14th day and 1st Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start1 Jun 2023
  3. Primary completion16 Jan 2026
  4. Study completion16 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were assigned to one of three parallel intervention arms: 1. a Concentrated Growth Factor (CGF) group, 2. a Collagen Fleece (CF) group, and 3. a control group receiving a collagen sponge.
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07367165
Sponsor's protocol ID
IUCREC.2023.82
Other IDs
TDH-2024-3515
Acronym
PAL-HEAL
Status last verified
Sep 2026
First submitted
17 Jan 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zucchelli G, Mounssif I. Periodontal plastic surgery. Periodontol 2000. 2015 Jun;68(1):333-68. doi: 10.1111/prd.12059.

    PubMed 25867992
  • Tavelli L, Barootchi S, Stefanini M, Zucchelli G, Giannobile WV, Wang HL. Wound healing dynamics, morbidity, and complications of palatal soft-tissue harvesting. Periodontol 2000. 2023 Jun;92(1):90-119. doi: 10.1111/prd.12466. Epub 2022 Dec 30.

    PubMed 36583690
  • Oliveira JA, da Silveira MI, Soares LFF, Alves RO, Carrera TMI, Azevedo MR, Oliveira GJPL, Pigossi SC. Wound-healing agents for palatal donor area: A network meta-analysis. Clin Oral Implants Res. 2024 Apr;35(4):359-376. doi: 10.1111/clr.14241. Epub 2024 Feb 5.

    PubMed 38315151
  • Lacoste E, Martineau I, Gagnon G. Platelet concentrates: effects of calcium and thrombin on endothelial cell proliferation and growth factor release. J Periodontol. 2003 Oct;74(10):1498-507. doi: 10.1902/jop.2003.74.10.1498.

    PubMed 14653397
  • Masuki H, Okudera T, Watanebe T, Suzuki M, Nishiyama K, Okudera H, Nakata K, Uematsu K, Su CY, Kawase T. Growth factor and pro-inflammatory cytokine contents in platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), advanced platelet-rich fibrin (A-PRF), and concentrated growth factors (CGF). Int J Implant Dent. 2016 Dec;2(1):19. doi: 10.1186/s40729-016-0052-4. Epub 2016 Aug 22.

    PubMed 27747711
  • Li G, Wang H. Novel Applications of Concentrated Growth Factors in Facial Rejuvenation and Plastic Surgery. Facial Plast Surg. 2024 Feb;40(1):112-119. doi: 10.1055/a-1987-3459. Epub 2022 Nov 24.

    PubMed 36423628
  • Voormolen JH, Ringers J, Bots GT, van der Heide A, Hermans J. Hemostatic agents: brain tissue reaction and effectiveness. A comparative animal study using collagen fleece and oxidized cellulose. Neurosurgery. 1987 May;20(5):702-9. doi: 10.1227/00006123-198705000-00005.

    PubMed 3601016
  • Bienz SP, Gadzo N, Zuercher AN, Wiedemeier D, Jung RE, Thoma DS. Clinical and histological wound healing patterns of collagen-based substitutes: An experimental randomized controlled trial in standardized palatal defects in humans. J Clin Periodontol. 2024 Mar;51(3):319-329. doi: 10.1111/jcpe.13903. Epub 2023 Nov 28.

    PubMed 38017650
  • Zhang T, Yuan M, Hao X, Gao H, Teng M, Hu F, Liang Y, Deng J, Li F. Innovative biomaterials in promoting intraoral wound healing: Mechanisms, applications, and challenges. Mater Today Bio. 2025 Oct 28;35:102470. doi: 10.1016/j.mtbio.2025.102470. eCollection 2025 Dec.

    PubMed 41255422
  • Basma HS, Saleh MHA, Abou-Arraj RV, Imbrogno M, Ravida A, Wang HL, Li P, Geurs N. Patient-reported outcomes of palatal donor site healing using four different wound dressing modalities following free epithelialized mucosal grafts: A four-arm randomized controlled clinical trial. J Periodontol. 2023 Jan;94(1):88-97. doi: 10.1002/JPER.22-0172. Epub 2022 Aug 3.

    PubMed 35754198

Questions about this trial

What is this clinical trial studying?

A study testing Concentrated Growth Factor (CGF) and Collagen Fleece (CF) in people with Wound Healing, run by Inonu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound Area at the Donor Site (time frame: Wound Area at Postoperative Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07367165, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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