Guided Bone Regeneration With and Without the Use of Intra-marrow Penetrations
1 other identifier
interventional
24
1 country
2
Brief Summary
The primary aims of this study are to compare, after 6 months, the clinical and histologic results of intra-marrow penetrations vs no intra-marrow penetrations when performing guided bone regeneration procedures.
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 Jun 2023
2 active sites
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
Study Start
First participant enrolled
June 15, 2023
CompletedFirst Submitted
Initial submission to the registry
October 13, 2023
CompletedFirst Posted
Study publicly available on registry
April 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 9, 2024
April 1, 2024
1 year
October 13, 2023
April 7, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Alveolar Ridge Width
Alveolar ridge width (measured in mm) after 6 months of healing
6 Months
Alveolar Ridge Height
Alveolar ridge height (measured in mm) after 6 months of healing
6 Months
Buccal Soft Tissue Thickness
Buccal soft tissue thickness at crest of alveolar ridge (measured in mm)
6 Months
Secondary Outcomes (1)
Histomorphometric Measurements
6 months
Study Arms (2)
Intra-marrow penetrations
EXPERIMENTALTwelve test patients will receive guided bone regeneration therapy with the use of intra-marrow penetrations prior to bone graft placement.
No Intra-marrow penetrations
ACTIVE COMPARATORTwelve test patients will receive guided bone regeneration therapy without the use of intra-marrow penetrations prior to bone graft placement.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male or female who is 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 diseases, or diseases that have a clinically significant effect on the periodontium.
- Presence or history of osteonecrosis of jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Patients with an allergy to any material or medication used in the study.
- Patients who need prophylactic antibiotics
- Previous head and neck radiation therapy.
- Chemotherapy in the previous 12 months.
- Patients on long term NSAID or steroid therapy.
- Pregnant patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Louisville
Louisville, Kentucky, 40202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The study involves an investigator (surgeon) and an examiner. The examiner measures the clinical parameters before and after surgery and is blinded to the surgical procedure and if intra-marrow penetrations are utilized.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Graduate Periodontics
Study Record Dates
First Submitted
October 13, 2023
First Posted
April 9, 2024
Study Start
June 15, 2023
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
April 9, 2024
Record last verified: 2024-04