Post-Extraction SocketNCT03422458
The Impact of Immediate Implant Placement on Alveolar Ridge Preservation Techniques
A study testing Alveolar Ridge Preservation in people with Post-Extraction Socket and Immediate Implant Placement, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
It is well known that following the loss of a single tooth, severe hard- and soft-tissue alterations may take place within the affected site, resulting in a subsequent reduction of both vertical and horizontal ridge dimensions, often not allowing neither appropiate pontic fabrication nor correct placement of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Extraction Socket, Immediate Implant Placement, Alveolar Ridge Preservation
- What is being tested?
- Alveolar Ridge Preservation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2016to 11 Apr 2018
- 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
- Adult patients (> 18 years old) requiring extraction (for caries, fracture, periodontitis, prosthetic reasons) and subsequent moderately rough implant-supported single crown of one upper or lower asymptomatic front tooth or premolar
- Systemically healthy patients not smoking more than 10 cigarettes/day.
- Oral healty patients with adequate oral hygiene (bleeding on probing < 30%; Plaque index< 30%).
Who cannot join
- Patients smoking more than 10 cigarettes per day.
- Patients with oral mucosa diseases
- Patients with insulin-dependent diabetes.
- Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
- Patient pregnant or intended to be pregnant or nursing
- Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs).
- Patients with a disease affecting connective tissue metabolism.
- Patients allergic to collagen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Immediate Implant Placement on Alveolar Ridge Preservation Techniques: a Clinical, Volumetric and Radiological Randomized Controlled Clinical Trial.
It is well known that following the loss of a single tooth, severe hard- and soft-tissue alterations may take place within the affected site, resulting in a subsequent reduction of both vertical and horizontal ridge dimensions, often not allowing neither appropiate pontic fabrication nor correct placement of endosseous implants.
Over the past 20 years, various surgical procedures, grouped under the term of "alveolar ridge preservation" (ARP), have been introduced, aiming to maintain the existing soft and hard tissue envelope as well as a stable ridge volume, simplifying subsequent treatment procedures and optimizing functional and esthetic outcomes. They have been widely tested in controlled and not controlled clinical studies with various materials and approaches, and a number of recently published systematic reviews on this topic have confirmed the efficacy of ARP in preventing post-extraction dimensional changes of alveolar ridges.
Read more
After these procedures a minimum of four to six months must be awaited before implant insertion can be performed, bringing the patient compromised comfort, function and aesthetics and needing of a second surgical procedure for the implant placement.
Dental implant insertion at the time of tooth extraction (type I or immediate placement) reduced the number of dental appointments, of surgeries required and the overall treatment time. Nevertheless this surgical protocol does not provide predictable outcomes, since it may contribute towards a more pronounced bone resorption during healing. Different anatomical factors, as the thickness of the buccal bone wall and the dimension of the horizontal gap, may influence the dimensional changes of the alveolar crest following immediate implant placement. Such morphological changes could lead to negative esthetic complications, such as marginal soft tissues recessions, especially when affecting the buccal side of maxillary sites in patients with a high smile line.
It is unknown if immediate implant placement plus grafting materials and/or barrier membranes could influence post-extraction dimensional changes of alveolar ridges. No consensus exists on the need for bone augmentation simultaneously with immediate implant placement. Furthermore, no human study has yet compared dimensional changes of both hard and soft tissues after two different treatments: an alveolar ridge preservation technique for a subsequent implant placement, and an alveolar ridge preservation technique with an immediate implant placement.
Read the detailed description
Hypothesis/Aims
Primary hypotesis
Placing an immediate implant into a fresh extraction site plus a bone substitute filling and a matrix covering could negatively modify the healing patterns and thus the tissue morphology of the ridge site with regard to:
- clinical hard tissues dimensions (bone width and height, bone volume)
- clinical soft tissues dimensions (soft tissues volume, keratinized tissues width and thickness, muco-gingival junction position's modifications, gingival color and texture,)
Secondary hypothesis.
Placing an immediate implant into fresh extraction site plus a bone substitute filling and a matrix covering could negatively influence tissue morphology of the preserved site with regard to:
- clinical hard tissues dimensions (bone width and height, bone volume)
- clinical soft tissues dimensions (soft tissues volume, keratinized tissues width and thickness, muco-gingival junction position's modifications, gingival color and texture,)
Aims:
The first aim of this study is to evaluate the possible impact on hard and soft tissue morphological changes of placing an immediate implant in post-extraction site treated by a bone substitute filling and a matrix covering.
The second aim of this study is to compare hard and soft tissue morphological changes in a spontaneous healed extraction site versus a fresh extraction site treated by immediate implant placement plus a bone substitute filling and a matrix covering
- Being tested
- Alveolar Ridge Preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Ridge PreservationDevice
Insertion of a bone substitute material (BioOss Collagen) within the bony envelope at least to the level of the palatal/ lingual bone plate. Adaptation of a collagen matrix (Mucograft Seal) to the soft tissue borders.
| Study group | Role | What they receive |
|---|---|---|
| natural healing | No intervention | no treatment and the coagulum within the socket is left open for spontaneous healing |
| Alveolar Ridge Preservation | Experimental | A bone substitute material (BioOss Collagen) is placed within the bony envelope at least to the level of the palatal/ lingual bone plate. Subsequently, the soft tissue borders of the alveole is de-epithelialized using a diamond drill under copious irrigation with water. A collagen matrix (Mucograft Seal) is adapted to the soft tissue borders again using single interrupted sutures. Receives: Device: Alveolar Ridge Preservation |
| Immediate Implant + Alveolar Ridge Preservation | Experimental | An immediate implant (Winsix) placement is performed. After implant insertion, a bone substitute material (BioOss Collagen) is placed in the gap occurred between the implant surface and the hard tissue walls of the extraction socket at least to the level of the palatal/ lingual bone plate. Subsequently, the soft tissue borders of the alveole is de-epithelialized using a diamond drill under copious irrigation with water. A collagen matrix (Mugograft Seal) is adapted to the soft tissue borders again using single interrupted sutures. Receives: Device: Alveolar Ridge Preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hard tissue volumetric changes
Bone volumes changes at tooth extraction site
Measured: 4 months
Soft tissue volumetric changes
Soft tissue volumes changes at tooth extraction site
Measured: 4 months
Secondary outcomes (1)
Keratinezed tissue (KT)
KT width changes at tooth extraction site
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Jan 2016
- Primary completion11 Apr 2018
- Study completion11 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Extraction SocketStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Osteology Foundation
- Responsible party
- Principal investigator, Marco Clementini, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422458
- Sponsor's protocol ID
- 14-034
- Status last verified
- Apr 2019
- First submitted
- 5 Jan 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
PubMed 23163915Clementini M, Castelluzzo W, Ciaravino V, Agostinelli A, Vignoletti F, Ambrosi A, De Sanctis M. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Soft tissue findings from a randomized controlled clinical trial. J Clin Periodontol. 2020 Dec;47(12):1536-1546. doi: 10.1111/jcpe.13369. Epub 2020 Oct 21.
PubMed 32956551Clementini M, Agostinelli A, Castelluzzo W, Cugnata F, Vignoletti F, De Sanctis M. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Radiographic results of a randomized controlled clinical trial. J Clin Periodontol. 2019 Jul;46(7):776-786. doi: 10.1111/jcpe.13125. Epub 2019 May 31.
PubMed 31050359
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Immediate Implant Placement on Alveolar Ridge Preservation Techniques: a Clinical, Volumetric and Radiological Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03422458
- Acronym / sponsor ID
- 14-034
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- Osteology Foundation
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 5 Feb 2018 (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 well known that following the loss of a single tooth, severe hard- and soft-tissue alterations may take place within the affected site, resulting in a subsequent reduction of both vertical and horizontal ridge dimensions, often not allowing neither appropiate pontic fabrication nor correct placement of endosseous implants.
Over the past 20 years, various surgical procedures, grouped under the term of "alveolar ridge preservation" (ARP), have been introduced, aiming to maintain the existing soft and hard tissue envelope as well as a stable ridge volume, simplifying subsequent treatment procedures and optimizing functional and esthetic outcomes. They have been widely tested in controlled and not controlled clinical studies with various materials and approaches, and a number of recently published systematic reviews on this topic have confirmed the efficacy of ARP in preventing post-extraction dimensional changes of alveolar ridges.
After these procedures a minimum of four to six months must be awaited before implant insertion can be performed, bringing the patient compromised comfort, function and aesthetics and needing of a second surgical procedure for the implant placement.
Dental implant insertion at the time of tooth extraction (type I or immediate placement) reduced the number of dental appointments, of surgeries required and the overall treatment time. Nevertheless this surgical protocol does not provide predictable outcomes, since it may contribute towards a more pronounced bone resorption during healing. Different anatomical factors, as the thickness of the buccal bone wall and the dimension of the horizontal gap, may influence the dimensional changes of the alveolar crest following immediate implant placement. Such morphological changes could lead to negative esthetic complications, such as marginal soft tissues recessions, especially when affecting the buccal side of maxillary sites in patients with a high smile line.
It is unknown if immediate implant placement plus grafting materials and/or barrier membranes could influence post-extraction dimensional changes of alveolar ridges. No consensus exists on the need for bone augmentation simultaneously with immediate implant placement. Furthermore, no human study has yet compared dimensional changes of both hard and soft tissues after two different treatments: an alveolar ridge preservation technique for a subsequent implant placement, and an alveolar ridge preservation technique with an immediate implant placement.
Detailed description
Hypothesis/Aims
Primary hypotesis
Placing an immediate implant into a fresh extraction site plus a bone substitute filling and a matrix covering could negatively modify the healing patterns and thus the tissue morphology of the ridge site with regard to:
- clinical hard tissues dimensions (bone width and height, bone volume)
- clinical soft tissues dimensions (soft tissues volume, keratinized tissues width and thickness, muco-gingival junction position's modifications, gingival color and texture,)
Secondary hypothesis.
Placing an immediate implant into fresh extraction site plus a bone substitute filling and a matrix covering could negatively influence tissue morphology of the preserved site with regard to:
- clinical hard tissues dimensions (bone width and height, bone volume)
- clinical soft tissues dimensions (soft tissues volume, keratinized tissues width and thickness, muco-gingival junction position's modifications, gingival color and texture,)
Aims:
The first aim of this study is to evaluate the possible impact on hard and soft tissue morphological changes of placing an immediate implant in post-extraction site treated by a bone substitute filling and a matrix covering.
The second aim of this study is to compare hard and soft tissue morphological changes in a spontaneous healed extraction site versus a fresh extraction site treated by immediate implant placement plus a bone substitute filling and a matrix covering
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| natural healing | No intervention | –no treatment and the coagulum within the socket is left open for spontaneous healing |
| Alveolar Ridge Preservation | Experimental | Device: Alveolar Ridge PreservationA bone substitute material (BioOss Collagen) is placed within the bony envelope at least to the level of the palatal/ lingual bone plate. Subsequently, the soft tissue borders of the alveole is de-epithelialized using a diamond drill under copious irrigation with water. A collagen matrix (Mucograft Seal) is adapted to the soft tissue borders again using single interrupted sutures. |
| Immediate Implant + Alveolar Ridge Preservation | Experimental | Device: Alveolar Ridge PreservationAn immediate implant (Winsix) placement is performed. After implant insertion, a bone substitute material (BioOss Collagen) is placed in the gap occurred between the implant surface and the hard tissue walls of the extraction socket at least to the level of the palatal/ lingual bone plate. Subsequently, the soft tissue borders of the alveole is de-epithelialized using a diamond drill under copious irrigation with water. A collagen matrix (Mugograft Seal) is adapted to the soft tissue borders again using single interrupted sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (> 18 years old) requiring extraction (for caries, fracture, periodontitis, prosthetic reasons) and subsequent moderately rough implant-supported single crown of one upper or lower asymptomatic front tooth or premolar
- Systemically healthy patients not smoking more than 10 cigarettes/day.
- Oral healty patients with adequate oral hygiene (bleeding on probing < 30%; Plaque index< 30%).
Key exclusion criteria (8 listed)
- Patients smoking more than 10 cigarettes per day.
- Patients with oral mucosa diseases
- Patients with insulin-dependent diabetes.
- Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
- Patient pregnant or intended to be pregnant or nursing
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 |
|---|---|---|
| Alveolar Ridge PreservationInsertion of a bone substitute material (BioOss Collagen) within the bony envelope at least to the level of the palatal/ lingual bone plate. Adaptation of a collagen matrix (Mucograft Seal) to the soft tissue borders. | Device | Alveolar Ridge Preservation, Immediate Implant + Alveolar Ridge Preservation |
Primary outcome
Hard tissue volumetric changes
Time frame: 4 months
Bone volumes changes at tooth extraction site
Soft tissue volumetric changes
Time frame: 4 months
Soft tissue volumes changes at tooth extraction site
1 secondary outcome
Keratinezed tissue (KT)
Time frame: 4 months
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 17 Apr 2019.
- Background: PubMed 23163915Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
- Derived from this study: PubMed 32956551Clementini M, Castelluzzo W, Ciaravino V, Agostinelli A, Vignoletti F, Ambrosi A, De Sanctis M. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Soft tissue findings from a randomized controlled clinical trial. J Clin Periodontol. 2020 Dec;47(12):1536-1546. doi: 10.1111/jcpe.13369. Epub 2020 Oct 21.
- Derived from this study: PubMed 31050359Clementini M, Agostinelli A, Castelluzzo W, Cugnata F, Vignoletti F, De Sanctis M. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Radiographic results of a randomized controlled clinical trial. J Clin Periodontol. 2019 Jul;46(7):776-786. doi: 10.1111/jcpe.13125. Epub 2019 May 31.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar Ridge Preservation in people with Post-Extraction Socket and Immediate Implant Placement, run by Università Vita-Salute San Raffaele 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 3 inclusion and 8 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 17 Apr 2019. 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?
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?
Hard tissue volumetric changes (time frame: 4 months). 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?
On the ClinicalTrials.gov record for NCT03422458, which also lists 3 linked publications.
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 17 Apr 2019.