Ridge Preservation Comparing Simultaneous vs. Delayed Grafting

Not Applicable

Terminated

• Conditions: Tooth Loss
• Interventions: Procedure: Simultaneous graft; Procedure: Delayed graft

• Registration Number: NCT03580798
• Lead Sponsor: University of Louisville

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-09
• Study Start: 2018-11-08
• Primary Completion: 2019-04-26
• Study Completion: 2019-04-26
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simultaneous Grafting	Simultaneous graft	At the time of extraction the socket will be grafted and implant placed 4 months later.
Delayed Grafting	Delayed graft	8 weeks after extraction implant placement and simultaneous osseous grafting.

Primary Outcome Measures

Name	Time	Method
Final ridge width for simultaneous and delayed grafting treatment.	16 to 20 weeks	Measure final ridge width to determine if adequate bone is available.

Secondary Outcome Measures

Name	Time	Method
Soft tissue thickness	16 to 20 weeks	Facial and occlusal
Histology	16 weeks	Histologic composition for control group only
Implant dehiscence	20 weeks	Implant dehiscence

Trial Locations

Locations (1)

Graduate Periodontics, UofL School of Dentistry; 🇺🇸 Louisville, Kentucky, United States