Single Tooth Extraction in Damaged Alveoli and Implant Site Development:TootToo
NCT ID: NCT05235048
Last Updated: 2022-04-01
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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COMPLETED
NA
160 participants
INTERVENTIONAL
2015-06-30
2017-09-30
Brief Summary
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The PICO question therefore is:
In patients requiring single tooth extraction what is the benefit of socket preservation/reconstruction surgery with respect to spontaneous healing in terms of feasibility and ease of implant surgery?
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Detailed Description
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The statistical design will be a superiority trial in terms of the primary outcome with reference to the standard of care control (spontaneous healing).
Primary outcome:
Possibility to place an implant in a prosthetically driven position with or without bone or soft tissue augmentation 16-20 weeks after tooth extraction, evaluated at planning with cone beam CT and confirmed at surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard of care control
Tooth extraction and spontaneous healing
Tooth extraction
Atraumatic tooth extraction without flap elevation
Socket seal with CT graft
Tooth extraction and socket sealing with autologous connective tissue graft
Tooth extraction
Atraumatic tooth extraction without flap elevation
Tooth extraction and socket seal with connective tissue graft
Atraumatic tooth extraction without flap elevation and seal of the alveolar socket with connective tissue graft (microsurgery)
Socket seal with CT graft and bone replacement graft
Tooth extraction and socket sealing with autologous connective tissue graft and positioning of bone replacement graft in coronal portion of the socket
Tooth extraction
Atraumatic tooth extraction without flap elevation
Tooth extraction and socket seal with connective tissue graft
Atraumatic tooth extraction without flap elevation and seal of the alveolar socket with connective tissue graft (microsurgery)
Tooth extraction and socket seal with BRG and connective tissue graft and
Atraumatic tooth extraction without flap elevation, position of a bone replacement graft into the socket and seal of the alveolar socket with connective tissue graft (microsurgery)
Tooth extraction and socket sealing and BRG with membrane
Tooth extraction and socket sealing with autologous connective tissue graft and positioning of bone replacement graft in coronal portion of the socket and positioning of collagen membrane
Tooth extraction
Atraumatic tooth extraction without flap elevation
Tooth extraction and socket seal with connective tissue graft
Atraumatic tooth extraction without flap elevation and seal of the alveolar socket with connective tissue graft (microsurgery)
Tooth extraction and socket seal with BRG and connective tissue graft and
Atraumatic tooth extraction without flap elevation, position of a bone replacement graft into the socket and seal of the alveolar socket with connective tissue graft (microsurgery)
Tooth extraction and socket seal with membrane placement, BRG and connective tissue graft
Atraumatic tooth extraction without flap elevation, position of a collagen membrane and bone replacement graft into the socket and seal of the alveolar socket with connective tissue graft (microsurgery)
Interventions
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Tooth extraction
Atraumatic tooth extraction without flap elevation
Tooth extraction and socket seal with connective tissue graft
Atraumatic tooth extraction without flap elevation and seal of the alveolar socket with connective tissue graft (microsurgery)
Tooth extraction and socket seal with BRG and connective tissue graft and
Atraumatic tooth extraction without flap elevation, position of a bone replacement graft into the socket and seal of the alveolar socket with connective tissue graft (microsurgery)
Tooth extraction and socket seal with membrane placement, BRG and connective tissue graft
Atraumatic tooth extraction without flap elevation, position of a collagen membrane and bone replacement graft into the socket and seal of the alveolar socket with connective tissue graft (microsurgery)
Eligibility Criteria
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Inclusion Criteria
* All pathologies requiring single tooth extraction with adjacent teeth (or implant) with the presence of at least one third of the alveolus.
* Evidence of subject ability to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS\<25% and FMBS\<25%)
* Ability to understand study procedures and to comply with them for the entire length of the study. Ability and willingness to give informed consent.
Exclusion Criteria
* Presence of bone resorption of one or more walls of the alveolus extending to the apical third of the socket
* Self reported current smoking exceeding 20 cigarettes/day or pipe or cigar smoking
* Presence of medical contraindications to elective surgery
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
The European Research Group on Periodontology (ERGOPerio)
NETWORK
Responsible Party
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Principal Investigators
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Pierpaolo Cortellini, MD
Role: STUDY_DIRECTOR
Investigator
Other Identifiers
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ERGOPerio 15-01
Identifier Type: -
Identifier Source: org_study_id
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