Ridge Preservation Comparing Simultaneous vs. Delayed Grafting

Tooth Loss Clinical Trial

Official title:

Ridge Preservation Comparing the Traditional Approach vs. Early Implant Placement With Simultaneous Contour Augmentation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03580798
• Other study ID #: 18.0348
• Status: Terminated
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: April 26, 2019

Study information

• Verified date: September 2020
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.

Description:

The primary aims of this study are to compare the clinical and histologic results of a traditional ridge preservation with implant placement at 16 weeks (control group) with early implant placement (8 weeks) with simultaneous contour augmentation as described by Buser (test group).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have one non-molar maxillary tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by 2 teeth.

• Healthy persons at least 18 years old.

• Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

• Patients with debilitating systemic disease, or diseases that have a clinically significant effect on the periodontium.

• Exclude any molar tooth.

• Presence of or history of osteonecrosis of jaws.

• Patients with current or previous history of IV bisphosphonates, irrespective of duration.

• Patients taking oral bisphosphonates for = 3 years.

• Pregnant women.

• Allergy to any material or medication used in the study.

• Patients who need prophylactic antibiotics prior to dental procedures.

• Previous head and neck radiation therapy.

• Chemotherapy in the previous 12 months.

Related Conditions & MeSH terms

• Tooth Loss

Intervention

Procedure:
• Delayed graft
8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.
• Simultaneous graft
At the time of extraction osseous graft will be placed in the socket and implant placed 4 months later.

Locations

Country	Name	City	State
United States	Graduate Periodontics, UofL School of Dentistry	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final ridge width for simultaneous and delayed grafting treatment.	Measure final ridge width to determine if adequate bone is available.	16 to 20 weeks
Secondary	Soft tissue thickness	Facial and occlusal	16 to 20 weeks
Secondary	Histology	Histologic composition for control group only	16 weeks
Secondary	Implant dehiscence	Implant dehiscence	20 weeks