Palatal Donor Site Wound HealingHA PalateNCT07458685
Influence of Hyaluronic Acid in the Healing of Palatal Donor Sites During Free Gingival Graft Procedures
A study testing Test - xHyA in people with Palatal Donor Site Wound Healing and Palatal Wound, run by University of Milan at 1 site in Italy.
Trial summary
The goal of this study is to evaluate the use of a gel containing cross-linked hyaluronic acid (xHyA) at the palatal donor site following soft tissue harvesting procedures. The main questions it aims to answer are: 1) Does the use of xHyA improve post-operative patient morbidity?; 2) Does the use of xHyA improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palatal Donor Site Wound Healing, Palatal Wound
- What is being tested?
- Test - xHyA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2022to 2 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Good general health (ASA 1 or 2)
- No local contraindications to implant surgery procedures (mucosal inflammation, active periodontal disease, erosive mucosal conditions, bone lesions, history of local radiation therapy and bruxism along with inadequate oral hygiene or lack of motivation for home care)
- Presence of two adjacent implants either submerged or prosthetically loaded
- Premolar and/or molar sectors of either the mandible or the maxilla
- Presence of < 2 mm of keratinized mucosa width at the buccal aspect of the said adjacent implants
Who cannot join
- Smokers (> 10 cigarettes/day)
- Subjects with known allergies to penicillin or collagen
- Poor oral hygiene
- Uncontrolled systemic pahologies
- Active periodontal infection
- No medical history of head and neck radiation therapy
Show all 9Show fewer
- No medical history of antiresorptive agents or steroids therapies
- Pregnant or lactating women
- Physical or mental disabilities affecting oral hygiene
Trial locations and contacts
1 site in 1 country.
Italy1 site
Implant Center for Edentulism and Jawbone Atrophies, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan
Milan, Lombardy, 20122
About this study
Official title: Efficacy of Cross-linked Hyaluronic Acid in Improving Healing After Free Gingival Graft: a Randomized Controlled Clinical Trial
The goal of this study is to evaluate the use of a gel containing cross-linked hyaluronic acid (xHyA) at the palatal donor site following soft tissue harvesting procedures. The main questions it aims to answer are: 1) Does the use of xHyA improve post-operative patient morbidity?; 2) Does the use of xHyA improve palatal donor site healing? Researchers will compare xHyA topically applied at the palatal donor site to a negative control to see if xHyA works to minimize participants' morbidity and improve clinical healing.
Participants will be equally distributed into two groups, half of them receiving xHyA. Participants will fill a visual analogue scale for subjective analyses during the first 2 post-operative weeks and will visit the dental clinic at 3, 7, 14 and 60 post-operative days for checkups and clinical examinations.
Read the detailed description
The aim of the present study is to evaluate the effects of topical cross-linked high molecular weight hyaluronic acid (xHyA) gel on postoperative patient discomfort and wound healing of palatal donor sites after free gingival graft (FGG) surgery.
Twenty patients requiring FGG are randomly assigned into two groups: negative control and a test group receiving xHyA gel in a single application. All surgical interventions are performed by the same surgical team. Anaesthesia of the palatal region is achieved with local infiltrations of mepivacaine 2% with epinephrine 1:100,000. The donor area is delimited by the distal line angle of the canine and the distal line angle of the second molar. A distance ≥ 2 mm from the gingival margin is respected. A half-thickness incision is made and a rectangular FGG with a thickness of ≈1.5 mm and dimensions of ≈20 × 5 mm in length x height respectively is harvested with a 15C scalpel under periodontal probe (PCP-UNC 15, Hu-Friedy Mfg. Co., LLC, Chicago, IL, USA) guidance maintaining a uniform thickness. A 1-minute moderate finger compression with a wet gauze is used to achieve initial haemostasis. Following soft tissue harvesting, in both groups a collagen sponge is placed to protect the palatal donor site, stabilized with cross-mattress sutures. In the test group, xHyA is injected over the exposed connective tissue and into the collagen sponge. In the negative control, the collagen sponge is left dry. In the immediate post-operative period, in order not to disturb the stabilization of the clot and the effects of the topical xHyA, participants are given instructions not to eat, drink, or rinse for about 4 hours. From the day after the surgery, participants are allowed to rinse passively with an ozone-based mouthwash (CollutO3, Innovares S.r.l., Reggio Emilia, Italy) for about 30 seconds twice daily for 2 post-operative weeks. Patients are placed on a soft diet with cold foods for the first week and are advised to avoid any mechanical or thermal trauma. Patients are also instructed not to brush and floss the upper teeth of the sector homolateral to the palatal donor area for one week. Nonsteroidal anti-inflammatory drugs (ibuprofen 600 mg every 6-8 hours up to 3 times a day) to be used as needed are prescribed for pain relief. Palatal sutures are removed after 7 days.
- Conditions
- Palatal Donor Site Wound Healing, Palatal Wound
- Being tested
- Test - xHyA, Negative control
- Keywords
- Free gingival graft, Healing, Hyaluronic acid, Palatal donor site, Palatal healing, Morbidity, Soft tissue harvesting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test - xHyADrug
Also called xHyA gel
The xHyA gel is contained in a 1.2 mL sterile cartridge containing highly purified 1.6% high molecular weight cross-linked HA and 0.2% natural HA to be injected with a 23G blunt needle. The xHyA gel is applied directly over the exposed connective tissue at the donor area and injected inside a resorbable collagen sponge that is stabilized to the donor site with silk sutures. No further applications of xHyA are planned during the study.
Negative controlOther
A dry collagen sponge not loaded with xHyA is adapted and stabilized to the donor area with a 4-0 silk cross mattress suture.
| Study group | Role | What they receive |
|---|---|---|
| Test - xHyA | Active comparator | Following palatal soft tissue harvesting, xHyA gel is injected over the exposed palatal connective tissue creating a layer of approximately 1-mm thickness, and a resorbable collagen sponge (CONDRESS®, EURORESEARCH S.r.l., Milan, Italy) soaked with xHyA is adapted and stabilized to the donor area with a 4-0 silk cross mattress suture. Receives: Drug: Test - xHyA |
| Negative control | Sham comparator | Following palatal soft tissue harvesting, a dry resorbable collagen sponge (CONDRESS®, EURORESEARCH S.r.l., Milan, Italy) is adapted and stabilized to the palatal donor area with a 4-0 silk cross mattress suture. Receives: Other: Negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective post-operative morbidity evaluation with a visual analogue scale during the first 2 post-operative weeks
The primary outcome of the study is to evaluate the post-operative participants morbidity. Subjective perception of pain, bleeding, burning sensation, discomfort while chewing and stress after free gingival graft harvesting are measured using a numerical rating scale, namely a 10-cm visual analogue scale with extreme endpoints at 0 and 10 marks ("no" and "extreme" respectively) recorded for each variable at one, 3, 7 and 14 post-operative days. The amount of analgesic consumption is also noted by each participant for the purpose of indirect pain measurement via mean consumption of analgesics.
Measured: 1, 3, 7 and 14 post-operative days.
Secondary outcomes (1)
Landry Wound Healing Index during the first 2 post-operative weeks
The secondary outcome of the study is the measurement of the palatal wound healing appearance using the Landry Wound Healing Index (LWHI), which has a score range from 1 (very poor) to 5 (excellent) in relation to different healing features including tissue colour, response to palpation, presence of granulation tissue, epithelialization of incision margins and amount of suppuration. The palatal wound healing using the LWHI is graded at 3, 7 and 14 post-operative days by an examiner masked to the type of treatment.
Measured: 3, 7 and 14 post-operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start5 Sep 2022
- Primary completion24 Jul 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Palatal Donor Site Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 are equally distributed to a control and a test group. A simple software-generated random number list with a research randomizer online tool (https://www.randomizer.org/) is used to randomly allocate the participants. In the negative control group, the palatal donor area is left to heal with no topical agent applied; in the xHyA test group, the palatal donor area is treated with xHyA gel topical application.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pier Paolo Poli, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458685
- Sponsor's protocol ID
- 558_2022bis
- Acronym
- HA Palate
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) or additional supporting documents will be shared. Data will remain confidential and stored securely at the Implant Center for Edentulism and Jawbone Atrophies, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, in accordance with institutional ethical approval.
Publications
Ceylan Sen S, Sarac Atagun O, Ustaoglu G, Ozcan E. Comparative evaluation of hyaluronic acid and injectable platelet-rich fibrin in palatal wound healing: a randomized clinical trial. BMC Oral Health. 2025 Oct 29;25(1):1693. doi: 10.1186/s12903-025-07183-9.
PubMed 41162972Cankaya ZT, Gurbuz S, Bakirarar B, Kurtis B. Evaluation of the Effect of Hyaluronic Acid Application on the Vascularization of Free Gingival Graft for Both Donor and Recipient Sites with Laser Doppler Flowmetry: A Randomized, Examiner-Blinded, Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2020 Mar/Apr;40(2):233-243. doi: 10.11607/prd.4494.
PubMed 32032408Khalil S, Habashneh RA, Alomari S, Alzoubi M. Local application of hyaluronic acid in conjunction with free gingival graft: a randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2165-2174. doi: 10.1007/s00784-021-04197-9. Epub 2021 Oct 8.
PubMed 34623507Alpan AL, Cin GT. Comparison of hyaluronic acid, hypochlorous acid, and flurbiprofen on postoperative morbidity in palatal donor area: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jun;27(6):2735-2746. doi: 10.1007/s00784-022-04848-5. Epub 2023 Jan 3.
PubMed 36595064Yildirim S, Ozener HO, Dogan B, Kuru B. Effect of topically applied hyaluronic acid on pain and palatal epithelial wound healing: An examiner-masked, randomized, controlled clinical trial. J Periodontol. 2018 Jan;89(1):36-45. doi: 10.1902/jop.2017.170105.
PubMed 28914592Joshi VM, Kandaswamy E, Germain JS, Schiavo JH, Fm HS. Effect of hyaluronic acid on palatal wound healing: A systematic review. Clin Oral Investig. 2024 Oct 3;28(10):565. doi: 10.1007/s00784-024-05955-1.
PubMed 39358570Asparuhova MB, Kiryak D, Eliezer M, Mihov D, Sculean A. Activity of two hyaluronan preparations on primary human oral fibroblasts. J Periodontal Res. 2019 Feb;54(1):33-45. doi: 10.1111/jre.12602. Epub 2018 Sep 27.
PubMed 30264516Pilloni A, Shirakata Y, Marini L, Bozic D, Miron RJ, Rotundo R, Stavropoulos A, Sculean A. Hyaluronic acid: A novel approach in regenerative/reconstructive periodontal therapy? Periodontol 2000. 2025 Oct;99(1):81-108. doi: 10.1111/prd.12644. Epub 2025 Aug 18.
PubMed 40820678Valachova K, Hassan ME, Soltes L. Hyaluronan: Sources, Structure, Features and Applications. Molecules. 2024 Feb 5;29(3):739. doi: 10.3390/molecules29030739.
PubMed 38338483Aya KL, Stern R. Hyaluronan in wound healing: rediscovering a major player. Wound Repair Regen. 2014 Sep-Oct;22(5):579-93. doi: 10.1111/wrr.12214.
PubMed 25039417Li CS, Lee WC, Fu MW, Ying-Shan Su S, Tzeng IS, Fu E. Bioactive materials for post-operative healing and pain relief following palatal epithelialized graft harvesting: A meta-analysis of randomized clinical trials. J Dent Sci. 2025 Apr;20(2):953-961. doi: 10.1016/j.jds.2024.11.013. Epub 2024 Nov 28.
PubMed 40224047Leite GG, Viana KSS, Cota LOM, Abreu LG, Esteves Lima RP, Costa FO. Efficacy of different interventions on the morbidity of the palatal donor area after free gingival graft and connective tissue graft: A systematic review. Jpn Dent Sci Rev. 2025 Dec;61:31-40. doi: 10.1016/j.jdsr.2025.03.001. Epub 2025 Mar 12.
PubMed 40151832de Almeida MCL, Rocha RGG, Magno MB, Lima RR, Saito MT. Performance of multiple therapeutic approaches for palatal wound healing after soft tissue graft removal - an overview of systematic reviews. Clin Oral Investig. 2024 May 31;28(6):347. doi: 10.1007/s00784-024-05733-z.
PubMed 38819478Burkhardt R, Hammerle CH, Lang NP; Research Group on Oral Soft Tissue Biology & Wound Healing. Self-reported pain perception of patients after mucosal graft harvesting in the palatal area. J Clin Periodontol. 2015 Mar;42(3):281-7. doi: 10.1111/jcpe.12357. Epub 2015 Feb 16.
PubMed 25544993Tavelli 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cross-linked Hyaluronic Acid in Improving Healing After Free Gingival Graft: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07458685
- Acronym / sponsor ID
- HA Palate / 558_2022bis
- Conditions
- Palatal Donor Site Wound Healing, Palatal Wound
- Keywords
- Free gingival graft, Healing, Hyaluronic acid, Palatal donor site, Palatal healing, Morbidity, Soft tissue harvesting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the use of a gel containing cross-linked hyaluronic acid (xHyA) at the palatal donor site following soft tissue harvesting procedures. The main questions it aims to answer are: 1) Does the use of xHyA improve post-operative patient morbidity?; 2) Does the use of xHyA improve palatal donor site healing? Researchers will compare xHyA topically applied at the palatal donor site to a negative control to see if xHyA works to minimize participants' morbidity and improve clinical healing.
Participants will be equally distributed into two groups, half of them receiving xHyA. Participants will fill a visual analogue scale for subjective analyses during the first 2 post-operative weeks and will visit the dental clinic at 3, 7, 14 and 60 post-operative days for checkups and clinical examinations.
Detailed description
The aim of the present study is to evaluate the effects of topical cross-linked high molecular weight hyaluronic acid (xHyA) gel on postoperative patient discomfort and wound healing of palatal donor sites after free gingival graft (FGG) surgery.
Twenty patients requiring FGG are randomly assigned into two groups: negative control and a test group receiving xHyA gel in a single application. All surgical interventions are performed by the same surgical team. Anaesthesia of the palatal region is achieved with local infiltrations of mepivacaine 2% with epinephrine 1:100,000. The donor area is delimited by the distal line angle of the canine and the distal line angle of the second molar. A distance ≥ 2 mm from the gingival margin is respected. A half-thickness incision is made and a rectangular FGG with a thickness of ≈1.5 mm and dimensions of ≈20 × 5 mm in length x height respectively is harvested with a 15C scalpel under periodontal probe (PCP-UNC 15, Hu-Friedy Mfg. Co., LLC, Chicago, IL, USA) guidance maintaining a uniform thickness. A 1-minute moderate finger compression with a wet gauze is used to achieve initial haemostasis. Following soft tissue harvesting, in both groups a collagen sponge is placed to protect the palatal donor site, stabilized with cross-mattress sutures. In the test group, xHyA is injected over the exposed connective tissue and into the collagen sponge. In the negative control, the collagen sponge is left dry. In the immediate post-operative period, in order not to disturb the stabilization of the clot and the effects of the topical xHyA, participants are given instructions not to eat, drink, or rinse for about 4 hours. From the day after the surgery, participants are allowed to rinse passively with an ozone-based mouthwash (CollutO3, Innovares S.r.l., Reggio Emilia, Italy) for about 30 seconds twice daily for 2 post-operative weeks. Patients are placed on a soft diet with cold foods for the first week and are advised to avoid any mechanical or thermal trauma. Patients are also instructed not to brush and floss the upper teeth of the sector homolateral to the palatal donor area for one week. Nonsteroidal anti-inflammatory drugs (ibuprofen 600 mg every 6-8 hours up to 3 times a day) to be used as needed are prescribed for pain relief. Palatal sutures are removed after 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are equally distributed to a control and a test group. A simple software-generated random number list with a research randomizer online tool (https://www.randomizer.org/) is used to randomly allocate the participants. In the negative control group, the palatal donor area is left to heal with no topical agent applied; in the xHyA test group, the palatal donor area is treated with xHyA gel topical application.
| Arm | Type | Receives |
|---|---|---|
| Test - xHyA | Active comparator | Drug: Test - xHyAFollowing palatal soft tissue harvesting, xHyA gel is injected over the exposed palatal connective tissue creating a layer of approximately 1-mm thickness, and a resorbable collagen sponge (CONDRESS®, EURORESEARCH S.r.l., Milan, Italy) soaked with xHyA is adapted and stabilized to the donor area with a 4-0 silk cross mattress suture. |
| Negative control | Sham comparator | Other: Negative controlFollowing palatal soft tissue harvesting, a dry resorbable collagen sponge (CONDRESS®, EURORESEARCH S.r.l., Milan, Italy) is adapted and stabilized to the palatal donor area with a 4-0 silk cross mattress suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Good general health (ASA 1 or 2)
- No local contraindications to implant surgery procedures (mucosal inflammation, active periodontal disease, erosive mucosal conditions, bone lesions, history of local radiation therapy and bruxism along with inadequate oral hygiene or lack of motivation for home care)
- Presence of two adjacent implants either submerged or prosthetically loaded
- Premolar and/or molar sectors of either the mandible or the maxilla
- Presence of < 2 mm of keratinized mucosa width at the buccal aspect of the said adjacent implants
Key exclusion criteria (9 listed)
- Smokers (> 10 cigarettes/day)
- Subjects with known allergies to penicillin or collagen
- Poor oral hygiene
- Uncontrolled systemic pahologies
- Active periodontal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test - xHyAAlso: xHyA gelThe xHyA gel is contained in a 1.2 mL sterile cartridge containing highly purified 1.6% high molecular weight cross-linked HA and 0.2% natural HA to be injected with a 23G blunt needle. The xHyA gel is applied directly over the exposed connective tissue at the donor area and injected inside a resorbable collagen sponge that is stabilized to the donor site with silk sutures. No further applications of xHyA are planned during the study. | Drug | Test - xHyA |
| Negative controlA dry collagen sponge not loaded with xHyA is adapted and stabilized to the donor area with a 4-0 silk cross mattress suture. | Other | Negative control |
Primary outcome
Subjective post-operative morbidity evaluation with a visual analogue scale during the first 2 post-operative weeks
Time frame: 1, 3, 7 and 14 post-operative days.
The primary outcome of the study is to evaluate the post-operative participants morbidity. Subjective perception of pain, bleeding, burning sensation, discomfort while chewing and stress after free gingival graft harvesting are measured using a numerical rating scale, namely a 10-cm visual analogue scale with extreme endpoints at 0 and 10 marks ("no" and "extreme" respectively) recorded for each variable at one, 3, 7 and 14 post-operative days. The amount of analgesic consumption is also noted by each participant for the purpose of indirect pain measurement via mean consumption of analgesics.
1 secondary outcome
Landry Wound Healing Index during the first 2 post-operative weeks
Time frame: 3, 7 and 14 post-operative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 41162972Ceylan Sen S, Sarac Atagun O, Ustaoglu G, Ozcan E. Comparative evaluation of hyaluronic acid and injectable platelet-rich fibrin in palatal wound healing: a randomized clinical trial. BMC Oral Health. 2025 Oct 29;25(1):1693. doi: 10.1186/s12903-025-07183-9.
- Background: PubMed 32032408Cankaya ZT, Gurbuz S, Bakirarar B, Kurtis B. Evaluation of the Effect of Hyaluronic Acid Application on the Vascularization of Free Gingival Graft for Both Donor and Recipient Sites with Laser Doppler Flowmetry: A Randomized, Examiner-Blinded, Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2020 Mar/Apr;40(2):233-243. doi: 10.11607/prd.4494.
- Background: PubMed 34623507Khalil S, Habashneh RA, Alomari S, Alzoubi M. Local application of hyaluronic acid in conjunction with free gingival graft: a randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2165-2174. doi: 10.1007/s00784-021-04197-9. Epub 2021 Oct 8.
- Background: PubMed 36595064Alpan AL, Cin GT. Comparison of hyaluronic acid, hypochlorous acid, and flurbiprofen on postoperative morbidity in palatal donor area: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jun;27(6):2735-2746. doi: 10.1007/s00784-022-04848-5. Epub 2023 Jan 3.
- Background: PubMed 28914592Yildirim S, Ozener HO, Dogan B, Kuru B. Effect of topically applied hyaluronic acid on pain and palatal epithelial wound healing: An examiner-masked, randomized, controlled clinical trial. J Periodontol. 2018 Jan;89(1):36-45. doi: 10.1902/jop.2017.170105.
- Background: PubMed 39358570Joshi VM, Kandaswamy E, Germain JS, Schiavo JH, Fm HS. Effect of hyaluronic acid on palatal wound healing: A systematic review. Clin Oral Investig. 2024 Oct 3;28(10):565. doi: 10.1007/s00784-024-05955-1.
- Background: PubMed 30264516Asparuhova MB, Kiryak D, Eliezer M, Mihov D, Sculean A. Activity of two hyaluronan preparations on primary human oral fibroblasts. J Periodontal Res. 2019 Feb;54(1):33-45. doi: 10.1111/jre.12602. Epub 2018 Sep 27.
- Background: PubMed 40820678Pilloni A, Shirakata Y, Marini L, Bozic D, Miron RJ, Rotundo R, Stavropoulos A, Sculean A. Hyaluronic acid: A novel approach in regenerative/reconstructive periodontal therapy? Periodontol 2000. 2025 Oct;99(1):81-108. doi: 10.1111/prd.12644. Epub 2025 Aug 18.
- Background: PubMed 38338483Valachova K, Hassan ME, Soltes L. Hyaluronan: Sources, Structure, Features and Applications. Molecules. 2024 Feb 5;29(3):739. doi: 10.3390/molecules29030739.
- Background: PubMed 25039417Aya KL, Stern R. Hyaluronan in wound healing: rediscovering a major player. Wound Repair Regen. 2014 Sep-Oct;22(5):579-93. doi: 10.1111/wrr.12214.
- Background: PubMed 40224047Li CS, Lee WC, Fu MW, Ying-Shan Su S, Tzeng IS, Fu E. Bioactive materials for post-operative healing and pain relief following palatal epithelialized graft harvesting: A meta-analysis of randomized clinical trials. J Dent Sci. 2025 Apr;20(2):953-961. doi: 10.1016/j.jds.2024.11.013. Epub 2024 Nov 28.
- Background: PubMed 40151832Leite GG, Viana KSS, Cota LOM, Abreu LG, Esteves Lima RP, Costa FO. Efficacy of different interventions on the morbidity of the palatal donor area after free gingival graft and connective tissue graft: A systematic review. Jpn Dent Sci Rev. 2025 Dec;61:31-40. doi: 10.1016/j.jdsr.2025.03.001. Epub 2025 Mar 12.
- Individual participant dataSharing planned: No. No individual participant data (IPD) or additional supporting documents will be shared. Data will remain confidential and stored securely at the Implant Center for Edentulism and Jawbone Atrophies, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, in accordance with institutional ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test - xHyA in people with Palatal Donor Site Wound Healing and Palatal Wound, run by University of Milan at 1 site in Italy.
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 5 inclusion and 9 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 9 Mar 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Subjective post-operative morbidity evaluation with a visual analogue scale during the first 2 post-operative weeks (time frame: 1, 3, 7 and 14 post-operative days.). 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 NCT07458685, which also lists 15 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 9 Mar 2026.