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NCT03659617 · ClinicalTrials.gov registry record · NA

Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen®

A NA study of Tooth Loss, sponsored by University of Iowa.

Completed
Registry status
NA
Development phase
39
Enrollment target
1
Study location

NCT03659617 is a NA study of Tooth Loss that has completed, run by University of Iowa. The registered enrollment target is 39 participants, below the 101-participant average among 11 other Tooth Loss trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03659617, a NA study of Tooth Loss, has completed, sponsored by University of Iowa.

COMPLETED
Registry status
NA
Development phase
39 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen® at 3, 6 and 9 months following tooth extraction in single-rooted tooth sites. Subjects with single rooted teeth planned for extraction and replacement with endosseous dental implants will be recruited for the study based on the eligibility criteria and will be divided in three groups (Groups 1, 2 and 3).A cone-beam computed tomography (CBCT) scan will be obtained and reviewed to prepare for the surgical approach and evaluate the ridge dimensions, the tooth planned for extraction as well as the adjacent sites. After tooth extraction, the socket will be grafted with Bio-Oss Collagen® and, depending on the morphology of the extraction sockets, a collagen matrix (Mucograft® seal) and/or a restorable collagen membrane (BioGide®)will be placed to cover and stabilize the graft. Patients will return at 2 and 6 weeks post-extraction to evaluate the healing. A second CBCT will be obtained 2 weeks prior to implant placement to evaluate the ridge dimensions and compare them to the baseline data. Implant placement will take place at 12, 24 and 36 after tooth extraction for Groups 1, 2 and 3 respectively. A bone core biopsy will be obtained at the time of implant placement and will be sent for histological analysis. Patients will return for a post-operative visit at two weeks. Clinical indices (probing depth, recession, bleeding upon probing, keratinized mucosa height, plaque and gingival index), patient reported outcomes and marginal bone levels via standardized periapical radiographs will be evaluated and recorded at baseline (no more than 30 days following delivery of final implant restoration) 1, 2 and 3 years post-loading.

Conditions Studied

Tooth Loss

Interventions

  • DEVICE xenograft (BioOss Collagen)

Study Locations (1)

Iowa

  • The University of Iowa College of Dentistry and Dental Clinics - Iowa City

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2018-12-10
Est. Completion 2025-05-22
Phase NA

Sponsor

University of Iowa

228 total trials

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What the Registry Record Tells You About NCT03659617

The ClinicalTrials.gov registry entry for NCT03659617 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 101-participant average among 11 other Tooth Loss trials with a reported enrollment target (61% lower). The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tooth Loss appearing as the primary indexed condition, and to 1 intervention - of which xenograft (BioOss Collagen) is the first listed.

NCT03659617 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.

Frequently Asked Questions

What is clinical trial NCT03659617 about?

NCT03659617 is a clinical study titled "Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen®". The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen® at 3, 6 and 9 months following tooth extraction in single-rooted tooth sites. Subjects with single rooted teeth planned for extract...

What is the current status of trial NCT03659617?

This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2018-12-10. Estimated completion is 2025-05-22.

What conditions does trial NCT03659617 study?

This clinical trial studies the following conditions: Tooth Loss.

What interventions are being tested in trial NCT03659617?

The interventions under investigation include: xenograft (BioOss Collagen) (DEVICE).

Who is sponsoring clinical trial NCT03659617?

This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03659617 being conducted?

This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.