An interventional study of Flowable Resin Composite Palatal Barrier and Self-Adhesive Oral Dressing in Perception of Pain and Protection of the Palate, sponsored by Universidad de Especialidades Espiritu Santo. Terminated at 1 site in Ecuador. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Universidad de Especialidades Espiritu Santo · Not applicable, Interventional, and Supportive care
The study was stopped before reaching the planned enrollment because the predefined recruitment period ended and an insufficient number of eligible participants was available.
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 12 is below the median of 66 across 8,493 interventional studies indexed under Pain.
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The criteria were revised on the registry on Oct 23, 2026. See what changed
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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.
Exclusion Criteria:
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.
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.
Device: Flowable Resin Composite Palatal Barrier
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.
Device: Self-Adhesive Oral Dressing
A hemostatic collagen sponge was covered by a light-cured flowable resin composite barrier bonded to the palatal enamel surfaces of the adjacent teeth.
A hemostatic collagen sponge was covered by a self-adhesive oral dressing stabilized with X-shaped 5-0 nylon sutures.
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.
Time frame: Daily from postoperative day 1 through postoperative day 14
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.
Time frame: 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.
Time frame: 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.
Time frame: From surgery through postoperative day 14
Twelve adults requiring free gingival graft harvesting for periodontal or peri-implant soft-tissue surgery were recruited from the Postgraduate Dental Clinic of Universidad de Especialidades Espíritu Santo. Recruitment ended before the planned sample size was reached because the predefined recruitment period concluded and an insufficient number of eligible participants was available.
| Milestone | Flowable Resin Composite | Self-Adhesive Oral Dressing |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
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.
| NRS points (0-10) | Flowable Resin Composite | Self-Adhesive Oral Dressing |
|---|---|---|
| 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 |
| Postoperative Day 9 | 0.67 ± 1.633 | 1.67 ± 1.033 |
| Postoperative Day 10 | 0.67 ± 1.211 | 1.33 ± 0.816 |
| Postoperative Day 11 | 0.5 ± 1.225 | 1. ± 0.894 |
| Postoperative Day 12 | 0.5 ± 1.225 | 0.33 ± 0.516 |
| Postoperative Day 13 | 0.33 ± 0.816 | 0 ± 0 |
| Postoperative Day 14 | 0.17 ± 0.408 | 0 ± 0 |
The elapsed time required to harvest the free gingival graft was measured in seconds using a stopwatch by a trained investigator.
| seconds | Flowable Resin Composite | Self-Adhesive Oral Dressing |
|---|---|---|
| Free Gingival Graft-Harvesting Time | 338.67 ± 63.573 | 332.17 ± 131.611 |
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.
| seconds | Flowable Resin Composite | Self-Adhesive Oral Dressing |
|---|---|---|
| Protective-Material Application Time | 484.83 ± 115.108 | 567.50 ± 59.383 |
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.
| days | Flowable Resin Composite | Self-Adhesive Oral Dressing |
|---|---|---|
| Intraoral Retention Time of the Protective Material | 11.17 ± 3.710 | 4.17 ± 2.317 |
Collected over From the surgical procedure through postoperative day 14. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Flowable Resin Composite | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Self-Adhesive Oral Dressing | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Flowable Resin Composite | Self-Adhesive Oral Dressing | Total |
|---|---|---|---|
| Mean | 39 ± 14 | 53.17 ± 8.70 | 46.08 ± 13.35 |
| Sex: Female, Male(Participants) | Flowable Resin Composite | Self-Adhesive Oral Dressing | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 2 | 2 | 4 |
| Race and Ethnicity Not Collected(Participants) | Flowable Resin Composite | Self-Adhesive Oral Dressing | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Graft Length (mm)(millimeters) | Flowable Resin Composite | Self-Adhesive Oral Dressing | Total |
|---|---|---|---|
| Mean | 18.83 ± 7.026 | 19.17 ± 5.879 | 19 ± 6.179 |
| Graft Width (mm)(millimeters) | Flowable Resin Composite | Self-Adhesive Oral Dressing | Total |
|---|---|---|---|
| Mean | 6 ± 1.2649 | 5.5 ± 0.5477 | 5.75 ± 0.965 |
| Graft Thickness (mm)(millimeters) | Flowable Resin Composite | Self-Adhesive Oral Dressing | Total |
|---|---|---|---|
| Mean | 2 ± 0.316 | 1.92 ± 0.204 | 1.96 ± 0.257 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The study was stopped before reaching the planned enrollment because the predefined recruitment period ended and an insufficient number of eligible participants was available.
The study was stopped before reaching the planned enrollment because the predefined recruitment period ended and an insufficient number of eligible participants was available.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Universidad de Especialidades Espiritu Santo