Single Tooth Extraction in Damaged Alveoli and Implant Site Development:TootToo
1 other identifier
interventional
160
0 countries
N/A
Brief Summary
It is unclear what is the best approach to implant site development after tooth extraction when the pathology leading to extraction has damaged the alveolus. The main objective of this study is to assess if socket preservation and/or reconstruction surgery provides a clinical benefit in terms of ability to place an implant in a prosthetically guided position in such clinical conditions. 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Typical duration for not_applicable
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 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedApril 1, 2022
March 1, 2022
2.3 years
January 11, 2020
March 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Possibility to place dental implant
The possibility to place a dental implant in a prosthetically driven position (with or without bone or soft tissue augmentation) 16-20 weeks after tooth extraction will be evaluated with a dedicated planning software using cone beam CT data and and digital scanning according to standard clinical practice
16-20 weeks
Surgeon's confirmation of the ability to place a dental implant
Confirmation during the surgery of the ability to actually insert the implant in a prosthetically driven position with or without the need for soft or hard-tissue augmentation.
16-20 weeks
Secondary Outcomes (8)
Vertical change in bone height at the deepest point in the socket
16-20 weeks
Vertical change in bone height at the buccal bone crest
16-20 weeks
Vertical change in bone height at the crest of adjacent teeth
16-20 weeks
Radiographic bone changes
16-20 weeks
Change in keratinized tissue width between baseline and insertion of prosthetic crown
16-20 weeks
- +3 more secondary outcomes
Study Arms (4)
Standard of care control
PLACEBO COMPARATORTooth extraction and spontaneous healing
Socket seal with CT graft
EXPERIMENTALTooth extraction and socket sealing with autologous connective tissue graft
Socket seal with CT graft and bone replacement graft
EXPERIMENTALTooth extraction and socket sealing with autologous connective tissue graft and positioning of bone replacement graft in coronal portion of the socket
Tooth extraction and socket sealing and BRG with membrane
EXPERIMENTALTooth 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
Interventions
Atraumatic tooth extraction without flap elevation
Atraumatic tooth extraction without flap elevation and seal of the alveolar socket with connective tissue graft (microsurgery)
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)
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
You may qualify if:
- Systemically healthy. No contraindications to elective oral surgery
- 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.
You may not qualify if:
- Presence of frank purulence or acute abscess at the time of extraction
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pierpaolo Cortellini, MD
Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Independent outcome assessor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2020
First Posted
February 10, 2022
Study Start
June 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
April 1, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
Data will not be shared