Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft
NCT ID: NCT04550689
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
12 participants
INTERVENTIONAL
2020-10-01
2024-06-30
Brief Summary
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Detailed Description
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PRIMARY OBJECTIVE
Horizontal and vertical dimensional changes of extraction sockets as evaluated in a CBCT scan immediately post extraction and 6 months post extraction when grafted with xenograft versus allograft.
SECONDARY OBJECTIVE
1. Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
2. Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
3. Difference in histologic analysis of bone biopsy cores taken in xenograft and allograft groups at 6 months re-entry from osteotomy site.
Difference in newly regenerated supracrestal bone height and volume will be measured directly from the segmented images from MicroCT.
NULL HYPOTHESIS
There is no difference between the two groups for any of the parameters evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Xenograft
Bone graft
Bone grafts produced by Straumann LLC
Allograft
Bone graft
Bone grafts produced by Straumann LLC
Interventions
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Bone graft
Bone grafts produced by Straumann LLC
Eligibility Criteria
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Inclusion Criteria
2. Able to provide informed consent
3. Good general oral health (no active periodontal disease, absence of hopeless teeth, absence of active caries, absence of acute infections)
4. Single rooted non molar teeth needing extraction for miscellaneous reasons (since histological analysis is being done, it is essential to harvest bone core biopsies without inclusion of native bone16)
5. Presence of natural teeth adjacent to the tooth planned for extraction
6. Absence of acute signs of infection such as pus discharge, fistulous tract and / or abscess in relation to tooth being extracted
7. Dehiscence type defects of the sockets limited to 2/3rd length of the root
Exclusion Criteria
1. Conditions and circumstances as evaluated by investigator that would prevent completion of study participation
2. Conditions requiring chronic routine use of antibiotics or steroids
3. History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infections
4. Alcoholism or drug abuse and heavy smokers \>10 cigarettes a day
5. Simultaneous participation in other studies
6. Pregnancy - Patients pregnant before the start of the study or patients who become pregnant during the course of the study
Local conditions
1. Untreated periodontitis, caries or presence of hopeless teeth (other than the one planned for extraction)
2. Multi rooted teeth
3. Irradiation therapy
4. Osseous lesions
5. Missing teeth adjacent to the tooth being extracted
6. Implant restorations adjacent to the tooth being extracted
7. Multiple socket walls missing following extraction or buccal dehiscence defect extending to the apex of the root
21 Years
ALL
Yes
Sponsors
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Institut Straumann AG
INDUSTRY
UConn Health
OTHER
Responsible Party
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Sejal Thacker
D.D.S., M.D.Sc., Graduate Program Director
Principal Investigators
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Sejal Thacker, D.D.S.
Role: PRINCIPAL_INVESTIGATOR
UConn Health
Locations
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UConn Health
Farmington, Connecticut, United States
Countries
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Other Identifiers
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601907
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20-137-1
Identifier Type: -
Identifier Source: org_study_id