Photobiomodulation vs. Palatal Stent for Palatal Donor Site Healing After Free Gingival Grafting
NCT07923916, Not applicable, Active not recruiting, Gulf Medical University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Photobiomodulation vs. Palatal Stent for Palatal Donor Site Healing After Free Gingival Grafting | ClinicalTrials.gov |
| NCT number | NCT07923916 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Gulf Medical University | ClinicalTrials.gov |
| Conditions | Mucogingival Deformity - Insufficient Keratinized Tissue, Lack of Keratinized Tissue, Wound Healing, Postoperative Pain, Palatal Donor Site Wound Healing | ClinicalTrials.gov |
| Interventions | Diode Laser Photobiomodulation (claros pico), Customized Acrylic Palatal Stent | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Percentage of Palatal Wound Closure | Baseline ($T_0$), Postoperative Days 7, 14, and 28 | Quantitative percentage reduction in palatal donor site wound area measured via 3D superimposition of digital intraoral scan files (STL format) relative to baseline ($T\_0$). Calculated as:$$\\text{Wound Closure (\\%)} = \\frac{\\text{Baseline Area } (T\_0) - \\text{Remaining Area } (T\_x)}{\\text{Baseline Area } (T\_0)} \\times 100$$ | ClinicalTrials.gov |
| Secondary | Degree of Complete Re-Epithelialization | Postoperative Days 7, 14, 21, and 28 | Binary assessment (Complete/Incomplete) of tissue re-epithelialization using the 3% hydrogen peroxide ($\\text{H}\_2\\text{O}\_2$) bubbling test. The absence of oxygen bubbling upon application indicates complete epithelial coverage over the palatal wound bed. | ClinicalTrials.gov |
| Secondary | Quality of Palatal Wound Healing (PMWHI Score) | Postoperative Days 3, 7, 14, 21, 28, and 3 months | Evaluation of soft tissue healing quality measured using the Palatal Mucosal Wound Healing Index (PMWHI, total score range 0-17). Lower scores represent superior healing (0-4: excellent, 5-8: satisfactory, 9-12: fair, 13-17: poor). | ClinicalTrials.gov |
| Secondary | Tissue Color Match | Postoperative Days 7, 14, 21, and 28 | Assessment of color match between the regenerating donor site mucosa and surrounding unoperated palatal tissue, evaluated on a 10-point Visual Analog Scale (VAS 0-10, where 0 = complete mismatch and 10 = identical color match). | ClinicalTrials.gov |
| Secondary | Postoperative Pain Intensity | Baseline ($T_0$), Postoperative Days 3, 7, and 14 | Patient-reported post-surgical pain intensity recorded using a 100-mm Visual Analog Scale (VAS 0-100 mm, where 0 mm = no pain and 100 mm = worst imaginable pain) | ClinicalTrials.gov |
| Secondary | Analgesic Consumption | Daily during the first 7 postoperative days | Total quantity of rescue pain medication (number of 600 mg Ibuprofen tablets) consumed by the participant per day for pain control. | ClinicalTrials.gov |
| Secondary | Functional Morbidity | Postoperative Days 3, 7, 14, and 28 | Patient-reported assessment of post-surgical functional impairment, including chewing/mastication difficulty, burning sensation, and bleeding discomfort, evaluated on a 10-point Visual Analog Scale (VAS 0-10) | ClinicalTrials.gov |
| Secondary | Postoperative Complications | Up to 28 days postoperatively | Incidence and severity of post-surgical complications, including secondary bleeding, swelling, hematoma, localized infection, delayed wound healing, speech impairment, or difficulty maintaining oral hygiene, recorded as binary incidence and event counts | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)