Pain ManagementNCT07501754
Use of a Custom-Made Acrylic Palatal Stent to Minimize Donor Site Morbidity After Suture-Free Epithelialized Gingival Graft Harvesting: A Randomized Clinical Trial
A study testing Custom-Made Acrylic Palatal Stent and No Palatal stent in people with Pain Management and Mucogingival Defects, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Epithelialized gingival graft (EGG) harvesting from the palate is associated with postoperative morbidity, including pain and bleeding, due to healing by secondary intention. The effectiveness of palatal stents in reducing donor-site morbidity, particularly in suture-free techniques, remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Mucogingival Defects, Healing
- What is being tested?
- Custom-Made Acrylic Palatal Stent and No Palatal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2025to 24 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- Patients requiring periodontal plastic surgery involving epithelialized gingival graft (EGG) harvesting from the palate
- Indications including keratinized tissue augmentation, soft tissue thickness augmentation, or root coverage procedures
- Adequate palatal tissue thickness to allow graft harvesting (≥2 mm)
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20%
- Ability to understand and complete patient-reported outcome questionnaires
- Signed informed consent
- Willingness to comply with study procedures and follow-up visits
Who cannot join
- compromised general health contraindicating the procedures (ASA III-VI)
- heavy smokers (≥ 10 cigarettes/day),
- systemic diseases or medications affecting treatment outcomes,
- known allergies or hypersensitivity to ibuprofen.
Trial locations and contacts
1 site in 1 country.
About this study
Epithelialized gingival graft (EGG) harvesting from the palate is associated with postoperative morbidity, including pain and bleeding, due to healing by secondary intention. The effectiveness of palatal stents in reducing donor-site morbidity, particularly in suture-free techniques, remains unclear.
This randomized controlled clinical trial evaluates the effect of a custom-made acrylic palatal stent (APS) compared with no stent on postoperative outcomes following EGG harvesting.
The primary outcome is postoperative pain assessed using a visual analog scale (VAS). Secondary outcomes include other patient-reported measures, clinician-reported healing, and exploratory assessments of tissue healing.
Read the detailed description
Epithelialized gingival graft (EGG) harvesting is widely used in periodontal plastic surgery but is associated with postoperative discomfort at the palatal donor site. Healing occurs by secondary intention and may result in pain, bleeding, and delayed recovery.
Palatal stents have been proposed as a mechanical approach to protect the wound and reduce morbidity; however, evidence supporting their effectiveness, especially in suture-free techniques, is limited.
This randomized controlled, assessor-blind, parallel-arm clinical trial aims to evaluate the effect of a custom-made acrylic palatal stent (APS) on postoperative morbidity following EGG harvesting. Patients were randomly assigned to receive APS or no stent after surgery.
The primary outcome is postoperative pain. Secondary outcomes include patient-reported measures, clinical healing parameters, and exploratory assessments of tissue healing.
- Conditions
- Pain Management, Mucogingival Defects, Healing
- Being tested
- Custom-Made Acrylic Palatal Stent, No Palatal stent
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-Made Acrylic Palatal StentDevice
A custom-made acrylic palatal stent (APS) will be fabricated prior to surgery based on an impression of the maxillary arch. The device will be thermoformed, trimmed, polished, and adjusted for proper fit and retention.
Following epithelialized gingival graft (EGG) harvesting, the APS will be positioned over the palatal donor site to provide mechanical protection and stabilization of the blood clot. The stent will be worn continuously during the early healing phase according to the study protocol.
No Palatal stentOther
Following epithelialized gingival graft (EGG) harvesting, no protective device will be applied to the palatal donor site. Hemostasis will be achieved through local anesthesia only, without the use of sutures, pressure, or additional hemostatic agents. Healing will occur by secondary intention
| Study group | Role | What they receive |
|---|---|---|
| Custom-Made Acrylic Palatal Stent | Experimental | A custom-made acrylic palatal stent (APS) will be fabricated prior to surgery based on an impression of the maxillary arch. The device will be thermoformed, trimmed, polished, and adjusted for proper fit and retention.
Following epithelialized gingival graft (EGG) harvesting, the APS will be positioned over the palatal donor site to provide mechanical protection and stabilization of the blood clot. The stent will be worn continuously during the early healing phase according to the study protocol. Receives: Device: Custom-Made Acrylic Palatal Stent |
| No palatal stent | Active comparator | Following epithelialized gingival graft (EGG) harvesting, no protective device will be applied to the palatal donor site. Hemostasis will be achieved through local anesthesia only, without the use of sutures, pressure, or additional hemostatic agents. Healing will occur by secondary intention Receives: Other: No Palatal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain at the palatal donor site
Postoperative pain assessed using a 100-mm visual analog scale (VAS), where 0 indicates no pain and 100 indicates worst imaginable pain. Patients will record pain daily using standardized questionnaires
Measured: 7 days after surgery
Secondary outcomes (7)
Postoperative bleeding
Patient-reported bleeding at the palatal donor site assessed using a 100-mm VAS
Measured: Daily from Day 1 to Day 7, Day 14, 21, 28
Postoperative swelling
Patient-reported swelling assessed using a 100-mm VAS.
Measured: Daily from Day 1 to Day 7, day 14, 21, 28
Analgesic consumption
Total intake of ibuprofen (mg) recorded by patients during the postoperative period.
Measured: 7 days after surgery
Oral health-related quality of life (OHIP-14)
Oral health-related quality of life assessed using the OHIP-14 questionnaire
Measured: Baseline, 7 days, 14 days, 21 days, 28 days
Willingness to undergo retreatment
Patient willingness to undergo a similar procedure in the future (yes/no)
Measured: 28 days after surgery
Epithelialization
Wound epithelialization assessed using hydrogen peroxide (H₂O₂) test and classified as none, partial, or complete.
Measured: 7 and 14 days after surgery
Clinical wound healing
Healing assessed from standardized photographs evaluating color match, tissue contour, and scar appearance using visual analog scales.
Measured: 7, 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start7 Jan 2025
- Primary completion24 Mar 2026
- Study completion24 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Aimetti, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501754
- Sponsor's protocol ID
- FGFTurin
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Custom-Made Acrylic Palatal Stent to Minimize Donor Site Morbidity After Suture-Free Epithelialized Gingival Graft Harvesting: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07501754
- Acronym / sponsor ID
- FGFTurin
- Conditions
- Pain Management, Mucogingival Defects, Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 May 2026 (actual)
- First posted
- 30 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.
Epithelialized gingival graft (EGG) harvesting from the palate is associated with postoperative morbidity, including pain and bleeding, due to healing by secondary intention. The effectiveness of palatal stents in reducing donor-site morbidity, particularly in suture-free techniques, remains unclear.
This randomized controlled clinical trial evaluates the effect of a custom-made acrylic palatal stent (APS) compared with no stent on postoperative outcomes following EGG harvesting.
The primary outcome is postoperative pain assessed using a visual analog scale (VAS). Secondary outcomes include other patient-reported measures, clinician-reported healing, and exploratory assessments of tissue healing.
Detailed description
Epithelialized gingival graft (EGG) harvesting is widely used in periodontal plastic surgery but is associated with postoperative discomfort at the palatal donor site. Healing occurs by secondary intention and may result in pain, bleeding, and delayed recovery.
Palatal stents have been proposed as a mechanical approach to protect the wound and reduce morbidity; however, evidence supporting their effectiveness, especially in suture-free techniques, is limited.
This randomized controlled, assessor-blind, parallel-arm clinical trial aims to evaluate the effect of a custom-made acrylic palatal stent (APS) on postoperative morbidity following EGG harvesting. Patients were randomly assigned to receive APS or no stent after surgery.
The primary outcome is postoperative pain. Secondary outcomes include patient-reported measures, clinical healing parameters, and exploratory assessments of tissue healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom-Made Acrylic Palatal Stent | Experimental | Device: Custom-Made Acrylic Palatal StentA custom-made acrylic palatal stent (APS) will be fabricated prior to surgery based on an impression of the maxillary arch. The device will be thermoformed, trimmed, polished, and adjusted for proper fit and retention. Following epithelialized gingival graft (EGG) harvesting, the APS will be positioned over the palatal donor site to provide mechanical protection and stabilization of the blood clot. The stent will be worn continuously during the early healing phase according to the study protocol. |
| No palatal stent | Active comparator | Other: No Palatal stentFollowing epithelialized gingival graft (EGG) harvesting, no protective device will be applied to the palatal donor site. Hemostasis will be achieved through local anesthesia only, without the use of sutures, pressure, or additional hemostatic agents. Healing will occur by secondary intention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults ≥18 years of age
- Patients requiring periodontal plastic surgery involving epithelialized gingival graft (EGG) harvesting from the palate
- Indications including keratinized tissue augmentation, soft tissue thickness augmentation, or root coverage procedures
- Adequate palatal tissue thickness to allow graft harvesting (≥2 mm)
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20%
Key exclusion criteria (4 listed)
- compromised general health contraindicating the procedures (ASA III-VI)
- heavy smokers (≥ 10 cigarettes/day),
- systemic diseases or medications affecting treatment outcomes,
- known allergies or hypersensitivity to ibuprofen.
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 |
|---|---|---|
| Custom-Made Acrylic Palatal StentA custom-made acrylic palatal stent (APS) will be fabricated prior to surgery based on an impression of the maxillary arch. The device will be thermoformed, trimmed, polished, and adjusted for proper fit and retention. Following epithelialized gingival graft (EGG) harvesting, the APS will be positioned over the palatal donor site to provide mechanical protection and stabilization of the blood clot. The stent will be worn continuously during the early healing phase according to the study protocol. | Device | Custom-Made Acrylic Palatal Stent |
| No Palatal stentFollowing epithelialized gingival graft (EGG) harvesting, no protective device will be applied to the palatal donor site. Hemostasis will be achieved through local anesthesia only, without the use of sutures, pressure, or additional hemostatic agents. Healing will occur by secondary intention | Other | No palatal stent |
Primary outcome
Postoperative pain at the palatal donor site
Time frame: 7 days after surgery
Postoperative pain assessed using a 100-mm visual analog scale (VAS), where 0 indicates no pain and 100 indicates worst imaginable pain. Patients will record pain daily using standardized questionnaires
7 secondary outcomes
Postoperative bleeding
Time frame: Daily from Day 1 to Day 7, Day 14, 21, 28
Postoperative swelling
Time frame: Daily from Day 1 to Day 7, day 14, 21, 28
Analgesic consumption
Time frame: 7 days after surgery
Oral health-related quality of life (OHIP-14)
Time frame: Baseline, 7 days, 14 days, 21 days, 28 days
Willingness to undergo retreatment
Time frame: 28 days after surgery
Epithelialization
Time frame: 7 and 14 days after surgery
Clinical wound healing
Time frame: 7, 14 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 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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 Custom-Made Acrylic Palatal Stent and No Palatal stent in people with Pain Management and Mucogingival Defects, run by University of Turin, Italy 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 8 inclusion and 4 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 2 Jul 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. 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?
Postoperative pain at the palatal donor site (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.