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NCT02980211 · ClinicalTrials.gov registry record · Phase 4
Treatment of Post-Extraction Dehisced Socket - A Case Series Study
A Phase 4 study of Tooth Loss, sponsored by Gustavo Avila-Ortiz DDS, MS, PhD.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT02980211: Completed Phase 4 study of Tooth Loss, sponsored by Gustavo Avila-Ortiz DDS, MS, PhD.
NCT02980211 is a Phase 4 study of Tooth Loss that has completed, run by Gustavo Avila-Ortiz DDS, MS, PhD. The registered enrollment target is 17 participants, below the 103-participant average among 11 other Tooth Loss trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02980211, a Phase 4 study of Tooth Loss, has completed, sponsored by Gustavo Avila-Ortiz DDS, MS, PhD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
PURPOSE The purpose of this case series is to clinically, radiographically and histologically evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane. METHODS Subjects with single-rooted teeth indicated for extraction and interested in future implant therapy for tooth replacement will be recruited on the basis of an eligibility criteria. A buccal or lingual dehiscence defect must strongly be suspected or confirmed upon clinical examination in order for the subject to qualify for study inclusion. A cone-beam computer tomography (CBCT) scan of the arch containing the tooth to be extracted will be obtained prior to tooth extraction. Following minimally invasive tooth extraction and debridement, the socket will be evaluated to verify the presence of a dehiscence defect affecting at least 50% of the bony plate height. After creating a soft tissue 'pouch' using tunneling instruments, a non-absorbable dense-PTFE (dPTFE) barrier membrane that will be trimmed to a size and shape that would allow for complete extension over the existing defect will be tucked between the mucosa and the alveolar bone. Then, the extraction socket will be grafted with particulate allograft and the access to the socket will be sealed with an extension of the membrane and an external cross mattress suture. Subjects will be recalled at 1, 2 and 5 weeks to monitor healing and assess the level of discomfort using a visual analog scale at the end of each visit. At the 5-week visit, the membrane will be gently removed and the exposed area will be left to heal by secondary intention. At 20 weeks after tooth extraction a second CBCT will be obtained to radiographically evaluate the site for implant placement. Bone volumetric reconstructions of the alveolar ridge at baseline and at 20 weeks will be made using the CBCT data to assess changes affecting the bone
Primary Outcome
Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans
Conditions Studied
Interventions
- DRUG Alveolar Ridge Reconstruction
Study Locations (1)
Iowa
- University of Iowa College of Dentistry - Craniofacial Clinical Research Program - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2018-05-17 |
| Phase | Phase 4 |
What the finished NCT02980211 record still lists
NCT02980211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 103-participant average among 11 other Tooth Loss trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Tooth Loss appearing as the primary indexed condition, and to 1 intervention - of which Alveolar Ridge Reconstruction is the first listed.
NCT02980211 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT02980211 about?
NCT02980211 is a clinical study titled "Treatment of Post-Extraction Dehisced Socket - A Case Series Study". PURPOSE The purpose of this case series is to clinically, radiographically and histologically evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane. ...
What is the current status of trial NCT02980211?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2017-03-01. Estimated completion is 2018-05-17.
What conditions does trial NCT02980211 study?
This clinical trial studies the following conditions: Tooth Loss.
What interventions are being tested in trial NCT02980211?
The interventions under investigation include: Alveolar Ridge Reconstruction (DRUG).
Who is sponsoring clinical trial NCT02980211?
This trial is sponsored by Gustavo Avila-Ortiz DDS, MS, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02980211 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02980211's enrollment target sits among peer trials
17 11th of 11 higher than 1 of 11 other Tooth Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tooth Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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