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NCT02844569 · ClinicalTrials.gov registry record · NA
A Volumetric Analysis of Soft and Hard Tissue Healing for Ridge Preservation and Socket Seal After Tooth Extraction
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT02844569 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants.
The verdict
NCT02844569, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will be a randomized clinical trial involving a total of 24 subjects. The investigators propose to recruit subjects into 2 groups: 1) Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®), 2) Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). All subjects recruited will have already been approved and treatment planned for extraction + implant placement by non-study personnel to avoid any potential conflict of interest. All subjects will have radiographs that show the tooth planned for extraction. Each subject will be eligible for only 1 tooth extraction + dental implant rehabilitation. After tooth extraction, subjects will receive a standard site preservation therapy consisted with xenograft bone substitute + collagen dressing or the alternative site preservation therapy consisted with xenograft bone substitute + 3D-collagen matrix. After the conventional 6-month healing period, subjects will receive a dental implant in the previous extracted site. During the dental implant procedure, a 2x5mm bone core biopsy + a 2mm gingival biopsy will be obtained from the implant site. Biopsy samples will be stored for future histological and histochemical analysis. After dental implant placement, all subjects will receive a healing abutment for soft tissue healing prior to implant restoration. During the 6-month healing time after tooth extraction and site preservation therapy, subjects will return at week-1, week-2, week-4, month-3, and month-6 for intra-oral scanning for soft tissue volumetric acquirement. Subjects will receive a Cone beam computed tomography (CBCT) prior to extraction for the baseline hard-tissue volume measurement and appropriate extraction planning and at 6-month post-extraction for volumetric measurement and appropriate implant treatment planning. Hard tissue analysis will be performed to compare linear ridge remodeling (baseline vs. 6-mont
Interventions
- DEVICE Xenograft bone substitute
- DEVICE Collagen dressing
- DEVICE 3D-collagen matrix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-07 |
| Est. Completion | 2018-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02844569
The ClinicalTrials.gov registry entry for NCT02844569 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Xenograft bone substitute is the first listed.
NCT02844569 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02844569 about?
NCT02844569 is a clinical study titled "A Volumetric Analysis of Soft and Hard Tissue Healing for Ridge Preservation and Socket Seal After Tooth Extraction". This study will be a randomized clinical trial involving a total of 24 subjects. The investigators propose to recruit subjects into 2 groups: 1) Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®), 2) Extraction treated with xenograft bone substitute ...
What is the current status of trial NCT02844569?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2016-07. Estimated completion is 2018-02-28.
What interventions are being tested in trial NCT02844569?
The interventions under investigation include: Xenograft bone substitute (DEVICE), Collagen dressing (DEVICE), 3D-collagen matrix (DEVICE).
Who is sponsoring clinical trial NCT02844569?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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