NCT07367165

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

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

June 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2025

Enrollment Period

2.6 years

First QC Date

January 17, 2026

Last Update Submit

January 26, 2026

Conditions

Wound Healing

Keywords

Concentrated Growth Factor (CGF)Collagen FleecePalatal Donor SiteSoft Tissue Graft HarvestingWound HealingOral Soft Tissue RegenerationPostoperative MorbidityGingival ThicknessPeriodontal Plastic SurgeryAutogenous Graft

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (6)

  • Re-epithelialization Assessed by H₂O₂ Bubbling Test

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

  • Wound Healing Quality - Landry-Turnbull-Howley (LTH) Index

    Postoperative Day 7, Day 14, and 1 Month

  • Scar Formation - Modified Manchester Scar Scale (MSS)

    Postoperative Day 7, Day 14, and 1 Month

  • Postoperative Pain - Visual Analog Scale (VAS)

    Postoperative Day 1, Day 3, Day 7, Day 14

  • Analgesic Consumption

    First 7 Days Postoperatively

  • +1 more secondary outcomes

Study Arms (3)

Concentrated Growth Factor (CGF)

EXPERIMENTAL
Biological: Concentrated Growth Factor (CGF)

Collagen Fleece (CF)

EXPERIMENTAL
Biological: Collagen Fleece (CF)

Control (Collagen Sponge)

EXPERIMENTAL
Biological: Collagen Sponge (Control)

Interventions

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.

Control (Collagen Sponge)
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.

Concentrated Growth Factor (CGF)
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 Fleece (CF)

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inönü University Faculty of Dentistry, Department of Periodontology

Malatya, 44000, Turkey (Türkiye)

Location

Related Publications (10)

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

    PMID: 25867992BACKGROUND

  • 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.

    PMID: 36583690BACKGROUND

  • 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.

    PMID: 38315151BACKGROUND

  • 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.

    PMID: 14653397BACKGROUND

  • 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.

    PMID: 27747711BACKGROUND

  • 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.

    PMID: 36423628BACKGROUND

  • 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.

    PMID: 3601016BACKGROUND

  • 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.

    PMID: 38017650BACKGROUND

  • 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.

    PMID: 41255422BACKGROUND

  • 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.

    PMID: 35754198BACKGROUND

MeSH Terms

Interventions

Collagen

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Periodontology, Inonu University Faculty of Dentistry

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 26, 2026

Study Start

June 1, 2023

Primary Completion

January 16, 2026

Study Completion

January 16, 2026

Last Updated

January 28, 2026

Record last verified: 2025-01

Locations

TU(1)