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NCT02450383 · ClinicalTrials.gov registry record · Phase 4
Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness
A Phase 4 study of Tooth Loss and Peri-implant Mucosa Defect, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02450383: Completed Phase 4 study of Tooth Loss and Peri-implant Mucosa Defect, sponsored by University of Iowa.
NCT02450383 is a Phase 4 study of Tooth Loss and Peri-implant Mucosa Defect that has completed, run by University of Iowa. The registered enrollment target is 20 participants, below the 102-participant average among 11 other Tooth Loss trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02450383, a Phase 4 study of Tooth Loss and Peri-implant Mucosa Defect, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults. AlloDerm is regulated by the US Food and Drug Administration (FDA) as human tissue for transplantation. AlloDerm is processed and marketed in accordance with the FDA's requirements for banked human tissue (21 CFR, Part 1270 and Part 1271) and Standards for Tissue Banking of the American Association of Tissue Banks (AATB). Twenty adult subjects will be recruited who are in need of dental implant placement with simultaneous gum grafting to increase the thickness of the facial mucosa. Half of the subjects will be randomized to the ADM group and half will be randomized to the sCTG group. The surgical intervention will be performed according to the protocol and subjects will return for follow-up 2, 4, 8, and 16 weeks post-surgery for follow-up measurements of healing, gum thickness, subject perception of pain, and esthetic photographs.
Primary Outcome
Buccal mucosa thickness measurements were obtained by a calibrated, masked examiner using a custom-made stent and an endo file for precision and reproducibility between different time points
Conditions Studied
Interventions
- DRUG Acellular Dermal Matrix
- PROCEDURE Autologous subepithelial connective tissue graft
Study Locations (1)
Iowa
- University of Iowa College of Dentistry - Craniofacial Clinical Research Center and Department of Periodontics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-09 |
| Phase | Phase 4 |
What the finished NCT02450383 record still lists
NCT02450383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 102-participant average among 11 other Tooth Loss trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Tooth Loss appearing as the primary indexed condition, and to 2 interventions - of which Acellular Dermal Matrix is the first listed.
NCT02450383 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT02450383 about?
NCT02450383 is a clinical study titled "Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness". The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults. AlloDerm is regulated by...
What is the current status of trial NCT02450383?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2015-01. Estimated completion is 2016-09.
What conditions does trial NCT02450383 study?
This clinical trial studies the following conditions: Tooth Loss, Peri-implant Mucosa Defect.
What interventions are being tested in trial NCT02450383?
The interventions under investigation include: Acellular Dermal Matrix (DRUG), Autologous subepithelial connective tissue graft (PROCEDURE).
Who is sponsoring clinical trial NCT02450383?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02450383 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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participants (enrollment target), bucketed by value
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