Ridge Preservation Comparing a Flap Versus Flapless Technique
Alveolar Ridge Preservation Using a Flap Versus Flapless Technique Using a Demineralized Bone Matrix Allograft Plus Mineralized Particulate Allograft and a Calcium Sulfate Barrier
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
To compare a flapless technique of alveolar ridge preservation to a flap technique to determine if preserving the periosteal blood supply would prevent loss of crestal ridge width and height.
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 Apr 2006
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
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedJune 6, 2023
June 1, 2023
1.1 years
February 12, 2020
June 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Crestal Horizontal Ridge Width
Changes in post-extraction to 4 month change in ridge measurements at the alveolar crest and 5 mm apical to crest. Measurements taken with a caliper.
4 months after surgery
Secondary Outcomes (1)
Percent osseous tissue
4 months after surgery
Study Arms (2)
Control
ACTIVE COMPARATORThe flap procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal.
Test
EXPERIMENTALThe test will be a flapless technique, no flap will be reflected.
Interventions
Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.
Eligibility Criteria
You may qualify if:
- Have one non-molar tooth requiring extraction that will be replaced with a dental implant where at least one adjacent tooth is present
- Study subjects at least 18 years old
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board.
You may not qualify if:
- Patients with debilitating systemic disease, or a disease affects the periodontium
- Have an allergy to any material or medication used in the study
- Require prophylactic antibiotics
- Previous head and neck radiation therapy
- Chemotherapy in the previous 12 months
- Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy
- Smoked more than one pack of cigarettes per day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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
- SPONSOR
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 17, 2020
Study Start
April 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
June 6, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share