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NCT04957342 · ClinicalTrials.gov registry record · NA
Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery
A NA study of Pain, Postoperative and Gingival Diseases, sponsored by Harvard Medical School (HMS and HSDM).
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04957342 is a NA study of Pain, Postoperative and Gingival Diseases that has completed, run by Harvard Medical School (HMS and HSDM). The registered enrollment target is 10 participants, below the 273-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04957342, a NA study of Pain, Postoperative and Gingival Diseases, has completed, sponsored by Harvard Medical School (HMS and HSDM).
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
When harvesting autogenous free grafts to treat periodontal conditions (e.g., lack of attached keratinized tissue, ridge defects, and other mucogingival deformities), the hard palate is the preferred donor site. The primary disadvantage of this technique is the creation of a second surgical site. This sacrificial traumatic lesion on the palate is associated with significant post-operative morbidities, including patient discomfort, infection, inflammation, hemorrhage, and necrosis. A pilot, blinded Randomized Control Trial will be conducted with subjects who are treatment planned to receive free gingival graft palatal harvest surgery. The palatal wound donor site for treatment group 1 will not receive an allograft membrane; while the donor site for treatment group 2 will receive an amnion-chorion allograft membrane (BioXclude) secured with a suture. The severity of pain at the palatal wound site will be assessed using an at home survey (Visual Analog Scale, Pain Catastrophizing Scale, \& Patient-Reported Outcomes Measurement Information System Scale). The healing of the palatal donor site will be evaluated quantitatively and qualitatively (PVS impression, optical scan, endoscopy, and ultrasnonography).
Conditions Studied
Interventions
- DEVICE amnion-chorion membrane
- PROCEDURE Sutures
Study Locations (1)
Massachusetts
- Harvard School of Dental Medicine - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-05-15 |
| Est. Completion | 2023-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04957342
The ClinicalTrials.gov registry entry for NCT04957342 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 273-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (96% lower). The listed sponsor is Harvard Medical School (HMS and HSDM), which has 26 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which amnion-chorion membrane is the first listed.
NCT04957342 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04957342 about?
NCT04957342 is a clinical study titled "Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery". When harvesting autogenous free grafts to treat periodontal conditions (e.g., lack of attached keratinized tissue, ridge defects, and other mucogingival deformities), the hard palate is the preferred donor site. The primary disadvantage of this technique is the creation of a second surgical site. Th...
What is the current status of trial NCT04957342?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2021-05-15. Estimated completion is 2023-07-01.
What conditions does trial NCT04957342 study?
This clinical trial studies the following conditions: Pain, Postoperative, Gingival Diseases.
What interventions are being tested in trial NCT04957342?
The interventions under investigation include: amnion-chorion membrane (DEVICE), Sutures (PROCEDURE).
Who is sponsoring clinical trial NCT04957342?
This trial is sponsored by Harvard Medical School (HMS and HSDM), which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04957342 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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