Evaluation Of New Shape of 3D Bone Plate in the Treatment of Posterior Mandibular Fractures
NCT07929896, Not applicable, Completed, Suez Canal University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation Of New Shape of 3D Bone Plate in the Treatment of Posterior Mandibular Fractures | ClinicalTrials.gov |
| NCT number | NCT07929896 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 20 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Suez Canal University | ClinicalTrials.gov |
| Conditions | Posterior Mandibular Fractures Involving the Body or Angle Region | ClinicalTrials.gov |
| Interventions | ORIF using Pin Buckle bone plate, ORIF using conventional two miniplates | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Radiographic Fracture-Line Width | Immediately postoperatively (baseline), 3 months, and 6 months postoperatively. | The width of the fracture line will be measured in millimeters using DIGORA image analysis software on standardized digital panoramic radiographs. Measurements will be performed at three standardized points (superior, middle, and inferior) along the visible fracture line, and the mean value will be calculated. Changes from baseline will be assessed at 3 and 6 months postoperatively and compared between the study and control groups. | ClinicalTrials.gov |
| Secondary | Change in Radiographic Bone Density at the Fracture Site | Immediately postoperatively (baseline), 3 months, and 6 months postoperatively. | Radiographic bone healing will be assessed by measuring the mean grayscale value at the fracture site using DIGORA image analysis software on standardized digital panoramic radiographs. Measurements will be performed using a standardized region of interest (ROI) at the immediate postoperative baseline, 3 months, and 6 months postoperatively. The change in mean grayscale values from baseline to 3 and 6 months will be evaluated and compared between the study and control groups. | ClinicalTrials.gov |
| Secondary | Postoperative Pain Intensity | Postoperative days 1, 7, and 14. | Postoperative pain intensity will be evaluated using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to indicate their pain intensity at each follow-up assessment. Pain scores will be compared between the study and control groups. | ClinicalTrials.gov |
| Secondary | Postoperative Facial Edema | Preoperatively (baseline) and postoperative days 1, 7, and 14. | Facial edema will be assessed using standardized tape measurements between two anatomical landmarks: the tragus and corner of the mouth, and the lateral canthus and gonion. The sum of the two measurements will be calculated. Changes in the summed measurements relative to the preoperative baseline will be used to evaluate postoperative facial edema and compared between the study and control groups. | ClinicalTrials.gov |
| Secondary | Postoperative Wound Healing | Postoperative days 1, 7, and 14. | Wound healing will be evaluated clinically using a structured scoring system consisting of five parameters: wound size reduction, tissue appearance, wound exudate, pain and inflammatory response, and mucosal integrity. Each parameter will be scored from 0 (poor) to 2 (good), resulting in a total score ranging from 0 to 10, with higher scores indicating better wound healing. Total wound healing scores will be compared between the study and control groups. | ClinicalTrials.gov |
| Secondary | Clinical Stability of Fracture Segments | Immediately postoperatively and 6 months postoperatively. | Fracture stability will be assessed by bimanual digital palpation to detect mobility between fracture segments during functional mandibular movements and manual manipulation. Fractures will be classified as stable (absence of detectable movement) or unstable (presence of detectable movement). The proportion of stable fractures will be compared between the study and control groups. | 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)