Trial · NCT07884331
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Width of Keratinized Gingiva | Baseline to 3 months after surgery | Change in keratinized gingival width in millimeters between the preoperative baseline assessment and the three-month postoperative assessment. Keratinized gingival width will be measured between the mucogingival junction and the midpoint of the alveolar ridge using digital intraoral scans obtained with a 3Shape TRIOS 6 intraoral scanner and analyzed using 3D Slicer software. |
| Secondary | Successful Closure of the Oro-Antral Communication | 14 days after surgery | Clinical success will be defined as complete closure of the oro-antral communication without persistent communication between the oral cavity and maxillary sinus. The proportion of successfully closed oro-antral communications will be calculated for each study group. |
| Secondary | Postoperative Pain | Day 0 through postoperative day 7 | Participants will record their daily maximum postoperative pain once daily in the afternoon using a visual analog scale from 0 to 10, where 0 represents no pain and 10 represents very severe pain. |
| Secondary | Postoperative Swelling | Day 0 through postoperative day 7 | Participants will record their daily maximum postoperative swelling once daily in the afternoon using a visual analog scale from 0 to 10, where 0 represents no swelling and 10 represents very severe swelling. |
| Secondary | Postoperative bleeding | Day 0 through postoperative day 7 | Participants will record their daily maximum postoperative bleeding once daily in the afternoon using a visual analog scale from 0 to 10, where 0 represents no postoperative bleeding and 10 represents very severe postoperative bleeding. |
| Secondary | Number of Participants with Postoperative Wound dehiscence | 14 days after surgery | Presence or absence of postoperative separation of the sutured buccal and palatal soft tissues will be clinically assessed 14 days after surgery. Participants will be classified as having wound dehiscence if separation of the wound edges is observed. If wound dehiscence is present, its dimensions will additionally be quantified using the intraoral scan. |
| Secondary | Dimensions of Postoperative Wound Dehiscence | 14 days after surgery | Among participants with postoperative wound dehiscence, the maximum dimensions of the separation of the sutured buccal and palatal soft tissues will be measured in milimeters using an intraoral scan 14 days after surgerx. |
| Secondary | Number of Participants with Recurrent or Persistent Oro-Antral Communication | Up to 3 months after surgery | Occurrence of a persistent or recurrent communication between the oral cavity and maxillary sinus during follow-up will be recorded. |
| Secondary | Number of Participants with Postoperative Sinusitis or Infection | 14 days after surgery | Occurrence of clinically diagnosed postoperative maxillary sinusitis or local infection at the follow-up examination after 14 days will be recorded. Clinical signs and symptoms may include facial pain, pressure sensation, purulent nasal discharge, intraoral purulent drainage, fever, or other clinically relevant signs of infection. |
| Secondary | Reoperation rate | 14 days after surgery | Percentage of participants in each study group requiring surgical revision because of insufficient closure of the oro-antral communication. |
| Secondary | Operative time | Intraoperatively on Day 0 | Duration of the surgical procedure measured from the first surgical incision to completion of the final suture, recorded in minutes and seconds. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07884331/registered