Perception of PainNCT06593275

Flowable Resin Versus Self-Adhesive Dressing for Palatal Donor-Site Protection

A study testing Flowable Resin Composite Palatal Barrier and Self-Adhesive Oral Dressing in people with Perception of Pain and Protection of the Palate, run by Universidad de Especialidades Espiritu Santo at 1 site in Ecuador.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Perception of Pain, Protection of the Palate
What is being tested?: Flowable Resin Composite Palatal Barrier and Self-Adhesive Oral Dressing
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteEcuador
Study dates: 30 Oct 2023to 1 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age 18 years or older. Full-mouth plaque score below 20%. Bleeding on probing below 10%. Clinical need for periodontal or peri-implant soft-tissue surgery involving free gingival graft harvesting.
No history of surgery at the selected palatal donor site.

Who cannot join

Pregnancy or breastfeeding. Active periodontal disease. Current smoking. Systemic disease or medical condition that could contraindicate surgery or interfere with wound healing.
Palatal mucosal lesions. Torus palatinus affecting the selected donor site. Use of a removable prosthesis covering the palate. History of chemotherapy or radiotherapy. Any condition that could interfere with the surgical procedure or postoperative assessments.

Trial locations and contacts

1 site in 1 country.

Ecuador1 site

Universidad de Especialidades Espiritu Santo
Samborondón, Guayas, 09-01-952

Other trials in Ecuador

About this study

Official title: Flowable Resin Composite Versus a Self-Adhesive Oral Dressing for Palatal Donor-Site Protection After Free Gingival Graft Harvesting: A Pilot Randomized Clinical Trial

This pilot randomized clinical study compared two methods for protecting the palatal donor site after harvesting a free gingival graft. Twelve adult participants were randomly assigned to receive either a hemostatic collagen sponge covered with flowable resin composite or a hemostatic collagen sponge covered with a self-adhesive oral dressing stabilized with sutures. Participants recorded pain at the palatal donor site daily for 14 days using a 0-to-10 pain scale. The study also evaluated the time required to apply each protective material and the number of days that it remained in place.

Read the detailed description

This single-center, two-arm, parallel-group pilot randomized clinical trial included 12 adults who required free gingival graft harvesting for periodontal or peri-implant soft-tissue surgery. Participants were randomly allocated in a 1:1 ratio to one of two palatal donor-site protection methods.

In the flowable resin composite group, a hemostatic collagen sponge was placed over the palatal wound. A flowable resin composite barrier was then bonded to the palatal enamel surfaces of the adjacent teeth to retain the collagen sponge and protect the donor site.

In the self-adhesive oral dressing group, the same type of hemostatic collagen sponge was placed over the palatal wound. A self-adhesive oral dressing was adapted over the collagen sponge and stabilized using X-shaped nylon sutures.

All participants received the same postoperative analgesic regimen and were followed for 14 days. The primary outcome was postoperative pain at the palatal donor site, recorded daily from postoperative day 1 through day 14 using an electronic 0-to-10 pain questionnaire. Secondary outcomes included graft-harvesting time, protective-material application time, and intraoral retention time until complete detachment of the assigned protective material.

Conditions: Perception of Pain, Protection of the Palate
Being tested: Flowable Resin Composite Palatal Barrier, Self-Adhesive Oral Dressing
Keywords: protection of the palate, pain palate, flow resine, self-adhesive dressing

What participants receive

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

Flowable Resin Composite Palatal BarrierDevice
A hemostatic collagen sponge was covered by a light-cured flowable resin composite barrier bonded to the palatal enamel surfaces of the adjacent teeth.
Self-Adhesive Oral DressingDevice
A hemostatic collagen sponge was covered by a self-adhesive oral dressing stabilized with X-shaped 5-0 nylon sutures.

Study groups in NCT06593275
Study group	Role	What they receive
Flowable Resin Composite	Active comparator	After free gingival graft harvesting and hemostasis, a hydrolyzed collagen hemostatic sponge was placed over the palatal donor-site wound. A flowable resin composite barrier was bonded to the palatal enamel surfaces of the adjacent teeth using an adhesive protocol and light-cured to form a rigid, tooth-supported protective covering. Sutures were not used to stabilize the resin barrier. Postoperative palatal pain was recorded daily for 14 days using a 0-to-10 pain scale. Receives: Device: Flowable Resin Composite Palatal Barrier
Self-Adhesive Oral Dressing	Experimental	After free gingival graft harvesting and hemostasis, a hydrolyzed collagen hemostatic sponge was placed over the palatal donor-site wound. A self-adhesive oral dressing was trimmed and adapted to extend approximately 2-3 mm beyond the wound margins and was stabilized using X-shaped 5-0 nylon sutures. Postoperative palatal pain was recorded daily for 14 days using a 0-to-10 pain scale. Receives: Device: Self-Adhesive Oral Dressing

What is being measured

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

Postoperative Pain Intensity at the Palatal Donor Site
Participants self-reported pain at the palatal donor site once daily using an 11-point numerical rating scale ranging from 0 (minimum pain) to 10 (maximum pain). Responses were collected electronically through Google Forms. Daily pain scores were recorded for each treatment arm throughout the 14-day postoperative period.
Measured: Daily from postoperative day 1 through postoperative day 14

Secondary outcomes (3)

Free Gingival Graft-Harvesting Time
The elapsed time required to harvest the free gingival graft was measured in seconds using a stopwatch by a trained investigator.
Measured: During the surgical procedure (day 0)
Protective-Material Application Time
The elapsed time from the beginning of preparation and application of the assigned protective material until completion of its placement was measured in seconds using a stopwatch by a trained investigator.
Measured: During the surgical procedure (day 0)
Intraoral Retention Time of the Protective Material
Retention time was measured as the number of days from surgery until complete detachment of the assigned protective material, as reported by the participant. Higher values indicated longer intraoral retention.
Measured: From surgery through postoperative day 14

Timeline

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

30 Oct 20231 Mar 2025

First posted19 Sep 2024
Study start30 Oct 2023
Primary completion15 Feb 2025
Study completion1 Mar 2025

Why it stopped: The study was stopped before reaching the planned enrollment because the predefined recruitment period ended and an insufficient number of eligible participants was available.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Perception of PainStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants were assigned in a 1:1 ratio to one of two parallel groups. Each participant contributed one palatal donor site and received only the allocated protection method throughout the study.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06593275
Sponsor's protocol ID: 2024-ODONT-002B
Status last verified: Jul 2026
First submitted: 9 Sep 2024
Last updated: 23 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.
PubMed 40228833
Garcia-Moreno S, Lopez-Pintor RM, Leco-Berrocal I, Torres J, Gonzalez-Serrano J. Impact of a Bioadhesive Oral Wound Dressing Combined With Flowable Resin on Patient-Reported Outcomes After Palatal Graft Harvesting: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 Mar;37(3):303-313. doi: 10.1111/clr.70070. Epub 2025 Nov 10.
PubMed 41212657
Temraz ME, Shemais N, Khalil E, Ghalwash D, Elbarbary A. Introducing flowable resin composite as a novel palatal dressing after free gingival graft harvesting: a randomized clinical trial. BDJ Open. 2025 Aug 25;11(1):75. doi: 10.1038/s41405-025-00362-4.
PubMed 40854876
Meza-Mauricio J, Mourao ERST, Oliveira Marinho K, Vergara-Buenaventura A, Mendoza-Azpur G, Muniz FWMG, Santamaria MP, Faveri M. Effect of collagen sponge and flowable resin composite on pain management after free gingival graft harvesting: A randomized controlled clinical trial. Eur J Oral Sci. 2023 Jun;131(3):e12935. doi: 10.1111/eos.12935. Epub 2023 May 11.
PubMed 37169726
Yussif N, Wagih R, Selim K. Propylene mesh versus acrylic resin stent for palatal wound protection following free gingival graft harvesting: a short-term pilot randomized clinical trial. BMC Oral Health. 2021 Apr 26;21(1):208. doi: 10.1186/s12903-021-01541-z.
PubMed 33902550
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
Burkhardt 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 25544993
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Flowable Resin Composite Versus a Self-Adhesive Oral Dressing for Palatal Donor-Site Protection After Free Gingival Graft Harvesting: A Pilot Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06593275
Acronym / sponsor ID: 2024-ODONT-002B
Conditions: Perception of Pain, Protection of the Palate
Keywords: protection of the palate, pain palate, flow resine, self-adhesive dressing
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was stopped before reaching the planned enrollment because the predefined recruitment period ended and an insufficient number of eligible participants was available.
Enrolment: 12 participants (actual)
Lead sponsor: Universidad de Especialidades Espiritu SantoUniversity, hospital or other
Study start: 30 Oct 2023 (actual)
Primary completion: 15 Feb 2025 (actual)
Study completion: 1 Mar 2025 (actual)
First posted: 19 Sep 2024 (actual)
Results: Posted 23 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants were assigned in a 1:1 ratio to one of two parallel groups. Each participant contributed one palatal donor site and received only the allocated protection method throughout the study.

Arm	Type	Receives
Flowable Resin Composite	Active comparator	Device: Flowable Resin Composite Palatal BarrierAfter free gingival graft harvesting and hemostasis, a hydrolyzed collagen hemostatic sponge was placed over the palatal donor-site wound. A flowable resin composite barrier was bonded to the palatal enamel surfaces of the adjacent teeth using an adhesive protocol and light-cured to form a rigid, tooth-supported protective covering. Sutures were not used to stabilize the resin barrier. Postoperative palatal pain was recorded daily for 14 days using a 0-to-10 pain scale.
Self-Adhesive Oral Dressing	Experimental	Device: Self-Adhesive Oral DressingAfter free gingival graft harvesting and hemostasis, a hydrolyzed collagen hemostatic sponge was placed over the palatal donor-site wound. A self-adhesive oral dressing was trimmed and adapted to extend approximately 2-3 mm beyond the wound margins and was stabilized using X-shaped 5-0 nylon sutures. Postoperative palatal pain was recorded daily for 14 days using a 0-to-10 pain scale.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age 18 years or older. Full-mouth plaque score below 20%. Bleeding on probing below 10%. Clinical need for periodontal or peri-implant soft-tissue surgery involving free gingival graft harvesting.
No history of surgery at the selected palatal donor site.

Key exclusion criteria (2 listed)

Pregnancy or breastfeeding. Active periodontal disease. Current smoking. Systemic disease or medical condition that could contraindicate surgery or interfere with wound healing.
Palatal mucosal lesions. Torus palatinus affecting the selected donor site. Use of a removable prosthesis covering the palate. History of chemotherapy or radiotherapy. Any condition that could interfere with the surgical procedure or postoperative assessments.

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
Flowable Resin Composite Palatal BarrierA hemostatic collagen sponge was covered by a light-cured flowable resin composite barrier bonded to the palatal enamel surfaces of the adjacent teeth.	Device	Flowable Resin Composite
Self-Adhesive Oral DressingA hemostatic collagen sponge was covered by a self-adhesive oral dressing stabilized with X-shaped 5-0 nylon sutures.	Device	Self-Adhesive Oral Dressing

Primary outcome

Postoperative Pain Intensity at the Palatal Donor Site
Time frame: Daily from postoperative day 1 through postoperative day 14
Participants self-reported pain at the palatal donor site once daily using an 11-point numerical rating scale ranging from 0 (minimum pain) to 10 (maximum pain). Responses were collected electronically through Google Forms. Daily pain scores were recorded for each treatment arm throughout the 14-day postoperative period.

3 secondary outcomes

Free Gingival Graft-Harvesting Time
Time frame: During the surgical procedure (day 0)
Protective-Material Application Time
Time frame: During the surgical procedure (day 0)
Intraoral Retention Time of the Protective Material
Time frame: From surgery through postoperative day 14

Results and safety

Results posted to the registry on 23 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Flowable Resin Composite	6	6
Self-Adhesive Oral Dressing	6	6

Primary outcome: Postoperative Pain Intensity at the Palatal Donor Site

Time frame: Daily from postoperative day 1 through postoperative day 14. Mean (Standard Deviation). Unit: NRS points (0-10)

Measure	Flowable Resin Composite n = 6	Self-Adhesive Oral Dressing n = 6
Postoperative Day 1	0.17 (0.408)	0.67 (1.633)
Postoperative Day 2	0 (0)	1 (1.549)
Postoperative Day 3	0 (0)	1 (1.265)
Postoperative Day 4	0 (0)	1.17 (1.835)
Postoperative Day 5	0 (0)	1.33 (1.751)
Postoperative Day 6	0 (0)	2 (1.673)
Postoperative Day 7	0.83 (1.602)	2 (1.095)
Postoperative Day 8	0.83 (1.602)	1.67 (1.033)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the surgical procedure through postoperative day 14. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flowable Resin Composite	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Self-Adhesive Oral Dressing	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): This pilot trial included only 12 participants because recruitment ended before the planned sample size was achieved. The small sample and single-center design limit the precision and generalizability of the findings. Participants and the operator could not be blinded because the interventions were visibly different, and pain was self-reported. Follow-up was limited to 14 days; therefore, the findings should be considered exploratory.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 40228833Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.
Background: PubMed 41212657Garcia-Moreno S, Lopez-Pintor RM, Leco-Berrocal I, Torres J, Gonzalez-Serrano J. Impact of a Bioadhesive Oral Wound Dressing Combined With Flowable Resin on Patient-Reported Outcomes After Palatal Graft Harvesting: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 Mar;37(3):303-313. doi: 10.1111/clr.70070. Epub 2025 Nov 10.
Background: PubMed 40854876Temraz ME, Shemais N, Khalil E, Ghalwash D, Elbarbary A. Introducing flowable resin composite as a novel palatal dressing after free gingival graft harvesting: a randomized clinical trial. BDJ Open. 2025 Aug 25;11(1):75. doi: 10.1038/s41405-025-00362-4.
Background: PubMed 37169726Meza-Mauricio J, Mourao ERST, Oliveira Marinho K, Vergara-Buenaventura A, Mendoza-Azpur G, Muniz FWMG, Santamaria MP, Faveri M. Effect of collagen sponge and flowable resin composite on pain management after free gingival graft harvesting: A randomized controlled clinical trial. Eur J Oral Sci. 2023 Jun;131(3):e12935. doi: 10.1111/eos.12935. Epub 2023 May 11.
Background: PubMed 33902550Yussif N, Wagih R, Selim K. Propylene mesh versus acrylic resin stent for palatal wound protection following free gingival graft harvesting: a short-term pilot randomized clinical trial. BMC Oral Health. 2021 Apr 26;21(1):208. doi: 10.1186/s12903-021-01541-z.
Background: PubMed 35754198Basma 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.
Background: PubMed 25544993Burkhardt 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.
Background: PubMed 36583690Tavelli 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.
Individual participant dataSharing planned: No

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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?

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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 23 Oct 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 Ecuador. 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?

Yes. Results are posted in the registry (first posted 23 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Intensity at the Palatal Donor Site (time frame: Daily from postoperative day 1 through postoperative day 14). 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 NCT06593275, which also lists 8 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 23 Oct 2026.