Tooth AvulsionNCT04299750
Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement
A study testing Tooth extraction and Alveolar ridge preservation and Tooth extraction in people with Tooth Avulsion, run by Simone Lumetti at 1 site in Italy.
Trial summary
The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Avulsion
- What is being tested?
- Tooth extraction and Alveolar ridge preservation and Tooth extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2016to Jul 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession;
- adequate oral hygiene, i.e. plaque index score ≤10%;
- mesial-distal width of inter-dental space ≥7 mm;
Who cannot join
- American Society of Anesthesiologists (ASA) score ≥III
- presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing
- a history of radiotherapy to the head and neck region
- presence of conditions requiring chronic use of antibiotics
- medical conditions requiring prolonged use of steroids
- history of leucocyte dysfunction
Show all 20Show fewer
- history of bleeding disorders
- history of renal failure
- patients with metabolic bone disorders
- patients with uncontrolled endocrine disorders
- disability affecting oral hygiene
- alcohol or drug abuse
- HIV infection
- smoking >10 cigarettes a day or cigar equivalents
- conditions or circumstances that would prevent completion of study participation
- mucosal diseases
- presence of osseous lesions
- severe bruxing or clenching habits
- persistent intraoral infections
- compromised alveolus (dehiscence, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Alveolar Ridge Preservation on Optimal Implant Placement
The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.
Read the detailed description
The main gol of the study is to assess the efficacy of a socket preservation procedure in reducing the need of additional surgeries in order to augment alveolar bone volume before placing a dental implant in optimal position. Bone volume at 6 months will be compared to initial volume in order to assess volume variations and how they affect the positioning of a prosthetically driven, implant.
- Conditions
- Tooth Avulsion
- Being tested
- Tooth extraction and Alveolar ridge preservation, Tooth extraction
- Keywords
- Socket preservation, Single implant, Tooth extraction
- Medical subject headings
- Tooth Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extraction and Alveolar ridge preservationProcedure or surgery
Also called Socket preservation
Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal
Tooth extractionProcedure or surgery
Also called Socket natural healing
Tooth extraction and socket natural healing
| Study group | Role | What they receive |
|---|---|---|
| Alveolar Ridge Preservation | Experimental | Patients in this arm will undergo atraumatic extraction of an hopeless tooth and a socket preservation procedure. Alveolar ridge preservation will be performed using a slow-resorption bone substitute and a collagen membrane that covers the graft. Receives: Procedure: Tooth extraction and Alveolar ridge preservation |
| Natural healing | Active comparator | Patients in this arm will undergo atraumatic extraction of an hopeless tooth. The socket will follow natural healing. Receives: Procedure: Tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of implants ideally placed
The main goal is to determine if alveolar ridge preservation affects optimal implant positioning. This is defined as the implant position allowing to fulfill the ideal prosthetic design of the crown to be restored.
Measured: 6 months
Secondary outcomes (2)
Peri-implant bone variation
Crestal bone levels (CBL): distances from the implant shoulder to the most coronal bone to implant contact measured on X-rays with a millimeter ruler to the nearest 0.5 mm. Two measurements will be taken for each implant: mesially and distally
Measured: 6 months
Ridge volume at 6 months after tooth extraction
The comparison of baseline and control cone.beam computed tomography and of clinical data in test and control groups will allow to determine volumetric effects on bone and soft tissues of socket preservation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study startOct 2016
- Primary completionNov 2019
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth AvulsionStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simone Lumetti
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables, Geistlich Pharma AG
- Responsible party
- Sponsor-investigator, Simone Lumetti, University of Parma
- Investigators
- Guido Macaluso, MDS, MSc, Study director, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299750
- Sponsor's protocol ID
- sockpres-13
- Status last verified
- Mar 2020
- First submitted
- 3 May 2015
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Alveolar Ridge Preservation on Optimal Implant Placement
- ClinicalTrials.gov ID
- NCT04299750
- Acronym / sponsor ID
- sockpres-13
- Conditions
- Tooth Avulsion
- Keywords
- Socket preservation, Single implant, Tooth extraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Simone LumettiUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables, Geistlich Pharma AG
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Jul 2020 (estimated)
- First posted
- 9 Mar 2020 (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.
The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.
Detailed description
The main gol of the study is to assess the efficacy of a socket preservation procedure in reducing the need of additional surgeries in order to augment alveolar bone volume before placing a dental implant in optimal position. Bone volume at 6 months will be compared to initial volume in order to assess volume variations and how they affect the positioning of a prosthetically driven, implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alveolar Ridge Preservation | Experimental | Procedure: Tooth extraction and Alveolar ridge preservationPatients in this arm will undergo atraumatic extraction of an hopeless tooth and a socket preservation procedure. Alveolar ridge preservation will be performed using a slow-resorption bone substitute and a collagen membrane that covers the graft. |
| Natural healing | Active comparator | Procedure: Tooth extractionPatients in this arm will undergo atraumatic extraction of an hopeless tooth. The socket will follow natural healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years of age
Key exclusion criteria (20 listed)
- American Society of Anesthesiologists (ASA) score ≥III
- presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing
- a history of radiotherapy to the head and neck region
- presence of conditions requiring chronic use of antibiotics
- medical conditions requiring prolonged use of steroids
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 extraction and Alveolar ridge preservationAlso: Socket preservationTooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal | Procedure or surgery | Alveolar Ridge Preservation |
| Tooth extractionAlso: Socket natural healingTooth extraction and socket natural healing | Procedure or surgery | Natural healing |
Primary outcome
Number of implants ideally placed
Time frame: 6 months
The main goal is to determine if alveolar ridge preservation affects optimal implant positioning. This is defined as the implant position allowing to fulfill the ideal prosthetic design of the crown to be restored.
2 secondary outcomes
Peri-implant bone variation
Time frame: 6 months
Ridge volume at 6 months after tooth extraction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
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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.
Guido Macaluso, MDS, MSc study director
University of Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth extraction and Alveolar ridge preservation and Tooth extraction in people with Tooth Avulsion, run by Simone Lumetti at 1 site in Italy.
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 20 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: status not confirmed, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Number of implants ideally placed (time frame: 6 months). 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 9 Mar 2020.