Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Clinical Trial

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

NCT: NCT03659617 · COMPLETED

NCT IDNCT03659617
StatusCOMPLETED
Start Date2018-12-10
Completion2025-05-22
SponsorUniversity of Iowa (OTHER)
First posted
Last updated

Brief 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.

Frequently Asked Questions

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

Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen® is a clinical trial registered under NCT03659617. Current status: COMPLETED.

What is the status of NCT03659617?

The current status of NCT03659617 (Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen®) is: COMPLETED.

When did Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen® start?

Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen® started on 2018-12-10.

Related Devices

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.