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Ridge Preservation Comparing Simultaneous vs. Delayed Grafting
Ridge Preservation Comparing the Traditional Approach vs. Early Implant Placement With Simultaneous Contour Augmentation
1 other identifier
interventional
7
1 country
1
Brief Summary
Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2018
CompletedFirst Posted
Study publicly available on registry
July 9, 2018
CompletedStudy Start
First participant enrolled
November 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2019
CompletedSeptember 10, 2020
September 1, 2020
6 months
June 13, 2018
September 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Soft tissue thickness
16 to 20 weeks
Histology
16 weeks
Implant dehiscence
20 weeks
Study Arms (2)
Delayed Grafting
EXPERIMENTAL8 weeks after extraction implant placement and simultaneous osseous grafting.
Simultaneous Grafting
ACTIVE COMPARATORAt the time of extraction the socket will be grafted and implant placed 4 months later.
Interventions
8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.
At the time of extraction osseous graft will be placed in the socket and implant placed 4 months later.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Graduate Periodontics, UofL School of Dentistry
Louisville, Kentucky, 40202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henry Greenwell, DMD
University of Louisville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Graduate Peridontics
Study Record Dates
First Submitted
June 13, 2018
First Posted
July 9, 2018
Study Start
November 8, 2018
Primary Completion
April 26, 2019
Study Completion
April 26, 2019
Last Updated
September 10, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share