Tooth Extraction Status NosNCT05235048
Single Tooth Extraction in Damaged Alveoli and Implant Site Development:TootToo
A study testing Tooth extraction, Tooth extraction and socket seal with connective tissue graft and Tooth extraction and socket seal with BRG and connective tissue graft and in people with Tooth Extraction Status Nos, run by The European Research Group on Periodontology (ERGOPerio).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction Status Nos
- What is being tested?
- Tooth extraction, Tooth extraction and socket seal with connective tissue graft and Tooth extraction and socket seal with BRG and connective tissue graft and
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Single Tooth Extraction in Damaged Alveoli and Implant Site Development Randomized Controlled Clinical Trial Comparing Socket Preservation and Reconstruction Surgery to Spontaneous Healing
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?
Read the detailed description
This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, clinical trial.
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
- Tooth Extraction Status Nos
- Being tested
- Tooth extraction, Tooth extraction and socket seal with connective tissue graft, Tooth extraction and socket seal with BRG and connective tissue graft and, Tooth extraction and socket seal with membrane placement, BRG and connective tissue graft
- Keywords
- Alveolar ridge preservation, Tooth extraction, Dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extractionProcedure or surgery
Atraumatic tooth extraction without flap elevation
Tooth extraction and socket seal with connective tissue graftProcedure or surgery
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 andProcedure or surgery
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 graftProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Standard of care control | Placebo comparator | Tooth extraction and spontaneous healing Receives: Procedure: Tooth extraction |
| Socket seal with CT graft | Experimental | Tooth extraction and socket sealing with autologous connective tissue graft Receives: Procedure: Tooth extraction; Procedure: Tooth extraction and socket seal with connective tissue graft |
| Socket seal with CT graft and bone replacement graft | Experimental | Tooth extraction and socket sealing with autologous connective tissue graft and positioning of bone replacement graft in coronal portion of the socket Receives: Procedure: Tooth extraction; Procedure: Tooth extraction and socket seal with connective tissue graft; Procedure: Tooth extraction and socket seal with BRG and connective tissue graft and |
| Tooth extraction and socket sealing and BRG with membrane | Experimental | 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 Receives: Procedure: Tooth extraction; Procedure: Tooth extraction and socket seal with connective tissue graft; Procedure: Tooth extraction and socket seal with BRG and connective tissue graft and; Procedure: Tooth extraction and socket seal with membrane placement, BRG and connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 16-20 weeks
Secondary outcomes (8)
Vertical change in bone height at the deepest point in the socket
Bone fill of the socket evaluated at the time of dental implant placement as change in the distance between a customized surgical stent and the bottom of the alveolus using a periodontal probe (difference between baseline and 16-20 week healing)
Measured: 16-20 weeks
Vertical change in bone height at the buccal bone crest
Bone fill of the socket evaluated at the time of dental implant placement as change in the distance between a customized surgical stent and the bottom of the alveolus using a periodontal probe (difference between baseline and 16-20 week healing)
Measured: 16-20 weeks
Vertical change in bone height at the crest of adjacent teeth
Harm to bone of adjacent teeth measured by clinical attachment level loss and trans gingival probing.
Measured: 16-20 weeks
Radiographic bone changes
Bone fill of the socket measured on routine intraoral radiographs
Measured: 16-20 weeks
Change in keratinized tissue width between baseline and insertion of prosthetic crown
Soft tissue preservation assessed as millimetre of keratinised tissue as measured with a periodontal probe
Measured: 16-20 weeks
Need for additional bone augmentation at the time of implant placement (and/or implant uncovering, if submerged healing)
Need for additional augmentation assessed by the surgeon during implant placement
Measured: 16-20 weeks
Wound healing index
Early healing assessed with standardized composite healing index by dentist
Measured: 1-4 weeks
OHIP-14
Oral health related quality of life standard instrument (questionnaire) - 5 point Likert scale with greater scores indicating better quality of life.
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study startJun 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Status NosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, superiority clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)
- Sponsor type
- Research network
- Collaborators
- The University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Pierpaolo Cortellini, MD, Study director, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235048
- Sponsor's protocol ID
- ERGOPerio 15-01
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2020
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Tooth Extraction in Damaged Alveoli and Implant Site Development Randomized Controlled Clinical Trial Comparing Socket Preservation and Reconstruction Surgery to Spontaneous Healing
- ClinicalTrials.gov ID
- NCT05235048
- Acronym / sponsor ID
- ERGOPerio 15-01
- Conditions
- Tooth Extraction Status Nos
- Keywords
- Alveolar ridge preservation, Tooth extraction, Dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)Research network
- Collaborators
- The University of Hong Kong
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, clinical trial.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, superiority clinical trial
| Arm | Type | Receives |
|---|---|---|
| Standard of care control | Placebo comparator | Procedure: Tooth extractionTooth extraction and spontaneous healing |
| Socket seal with CT graft | Experimental | Procedure: Tooth extraction, Procedure: Tooth extraction and socket seal with connective tissue graftTooth extraction and socket sealing with autologous connective tissue graft |
| Socket seal with CT graft and bone replacement graft | Experimental | Procedure: Tooth extraction, Procedure: Tooth extraction and socket seal with connective tissue graft, Procedure: Tooth extraction and socket seal with BRG and connective tissue graft andTooth 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 | Experimental | Procedure: Tooth extraction, Procedure: Tooth extraction and socket seal with connective tissue graft, Procedure: Tooth extraction and socket seal with BRG and connective tissue graft and, Procedure: Tooth extraction and socket seal with membrane placement, BRG and connective tissue graftTooth 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth extractionAtraumatic tooth extraction without flap elevation | Procedure or surgery | Socket seal with CT graft, Socket seal with CT graft and bone replacement graft, Standard of care control, Tooth extraction and socket sealing and BRG with membrane |
| Tooth extraction and socket seal with connective tissue graftAtraumatic tooth extraction without flap elevation and seal of the alveolar socket with connective tissue graft (microsurgery) | Procedure or surgery | Socket seal with CT graft, Socket seal with CT graft and bone replacement graft, Tooth extraction and socket sealing and BRG with membrane |
| Tooth extraction and socket seal with BRG and connective tissue graft andAtraumatic 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) | Procedure or surgery | Socket seal with CT graft and bone replacement graft, Tooth extraction and socket sealing and BRG with membrane |
| Tooth extraction and socket seal with membrane placement, BRG and connective tissue graftAtraumatic 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) | Procedure or surgery | Tooth extraction and socket sealing and BRG with membrane |
Primary outcome
Possibility to place dental implant
Time frame: 16-20 weeks
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
Surgeon's confirmation of the ability to place a dental implant
Time frame: 16-20 weeks
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.
8 secondary outcomes
Vertical change in bone height at the deepest point in the socket
Time frame: 16-20 weeks
Vertical change in bone height at the buccal bone crest
Time frame: 16-20 weeks
Vertical change in bone height at the crest of adjacent teeth
Time frame: 16-20 weeks
Radiographic bone changes
Time frame: 16-20 weeks
Change in keratinized tissue width between baseline and insertion of prosthetic crown
Time frame: 16-20 weeks
Need for additional bone augmentation at the time of implant placement (and/or implant uncovering, if submerged healing)
Time frame: 16-20 weeks
Wound healing index
Time frame: 1-4 weeks
OHIP-14
Time frame: 1-2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No. Data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierpaolo Cortellini, MD study director
Investigator
Questions about this trial
What is this clinical trial studying?
A study testing Tooth extraction, Tooth extraction and socket seal with connective tissue graft and Tooth extraction and socket seal with BRG and connective tissue graft and in people with Tooth Extraction Status Nos, run by The European Research Group on Periodontology (ERGOPerio).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Possibility to place dental implant (time frame: 16-20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.