Non-maintainable Posterior Tooth (Molars and Premolars)Phase 4NCT04553146
Clinical and Dimensional Outcomes of Sealing Socket Abutment Combined to Alveolar Ridge Preservation
A Phase 4 study testing Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutment in people with Non-maintainable Posterior Tooth (Molars and Premolars), run by University of Liege at 1 site in Belgium.
Trial summary
objectives The aim of this study was to assess the implant outcomes as well as hard and soft tissue dimensional changes of immediate implant placement in posterior sites using a custom-made sealing socket abutment (SSA) combined to alveolar ridge preservation (ARP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-maintainable Posterior Tooth (Molars and Premolars)
- What is being tested?
- Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Aug 2018to 31 Aug 2025
- Phase
- Phase 4
- 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
- good general health (ASA I/II),
- more than 18 years old,
- non smoker,
- one hopeless tooth,
- healthy periodontal condition,
- the presence of at least 2 mm of keratinized gingiva,
- adequate plaque control (FMPS ≤ 25%), adequate bone quantity in the septum if present and at least 5 mm of bone in the apical region
Who cannot join
- auto-immune disease or immunocompromised patients,
- uncontrolled diabetes,
- use of steroids or biphosphonates,
- local or systemic infection (medical treatment needed prior to entrance to the study), pregnancy or breastfeeding, alcoholism or chronically drug abuse.
- Local exclusion criteria:
- bone availability requiring an angulated abutment,
Show all 11Show fewer
- untreated local inflammation,
- cyst,
- mucosal disease or oral lesions,
- local irradiation therapy,
- oral communication with sinus after the extraction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Implant Placement in the Posterior Region Combining Socket Seal Abutment and Alveolar Ridge Preservation: Implant, Hard and Soft Tissue Outcomes After 1 Year, 3 Years and 5 Years
objectives
The aim of this study was to assess the implant outcomes as well as hard and soft tissue dimensional changes of immediate implant placement in posterior sites using a custom-made sealing socket abutment (SSA) combined to alveolar ridge preservation (ARP).
Read more
Material and methods
Twenty posterior teeth were immediately replaced with implants in 20 patients. The remaining sockets were filled with Deproteinized Bovine Bone Mineral. Based on intra-oral scanners (IOS), custom-made SSAs were placed the same day. CBCT and IOS were performed to monitor hard and soft tissue dimensional changes. Moreover, implant survival rate, peri-implant bone changes, peri-implant health and pink esthetic score were recorded at 1 year, 3years and 5 years.
Read the detailed description
Study population
Hopeless maxillary or mandibular molars with tooth anatomy and bone anchorage allowing an immediate implant procedure: apical bone height of at least 5 mm or presence of interradicular septum, socket with intact bone walls, absence a large apical periodontitis, Patients needing tooth replacement in the posterior region (molars) will be recruited from the Department of Periodontology and Oral and Implant Surgery of the University of Liège, Belgium.
Procedures
After a local anesthesia, one of the two experienced surgeons (LF or LG) proceeded to the least traumatic extraction of the concerned tooth. The consecutive drills for implant placement were carried out while considering the future position of the crown for a screw- retained restoration. Twenty BLX implants (Roxolid®, SLAactive®, Institut Straumann AG) were placed flapless with a sufficient apical or septum anchorage and the insertion torque was recorded. The gap around the implant was filled with deproteinized bovine bone mineral (DBBM) (cerabone®, botiss biomaterials GmbH).
Just after the implant placement, an intra-oral scan (IOS) (Trios 3®, 3-Shape) with a scanbody connected onto the implant platform was performed and sent to the dental laboratory to digitally design (Dental Wings®) a customized healing abutment. The SSA was then milled (CARES®, Institut Straumann AG) from a block of PEEK (JUVORATMPEEK, JUVORATM Ltd. National Distributor: Institut Straumann AG), cemented to a titanium abutment (Variobase®, Institut Straumann AG) and provided to the patient on the same day. During manufacturing of the SSA, a conventional healing abutment was screwed on the implant and a collagen sponge (Collaplug®) was provisionally placed buccally to protect the exposed biomaterial until the placement of the SSA. A standardized parallel peri-apical radiograph using a custom-made film holder was taken in order to record the baseline bone level. Each patient was instructed to rinse twice daily with an aqueous solution of 0.2% chlorhexidine (Corsodyl®, GSK) and to avoid brushing of the area until the first recall 10-12 days later. Anti-inflammatories (Ibuprofen® 600 mg) and additional analgesics (Paracetamol® 500 mg) were prescribed and taken according to the patient's needs. If the surgeon deemed it necessary, an anti- biotic was prescribed (Amoxicillin® 500mg 3x/day during 5 days). Three months after implantation, the abutment was removed, the osseointegration of the implant was checked and the final lithium aluminosilicate ceramic reinforced with lithium disilicate monolithic crown (n!ce® glass-ceramic block, Institut Straumann AG) based on the initial IOS was cemented to a titanium abutment (Variobase®, Institut Straumann AG) and placed. The transmucosal design from the SSA was replicated on the final crown. Follow-up evaluations and data recording will be performed 7-10 days, 3 months, 6 months, 12 months, 3years and 5years after the surgery.
- Being tested
- Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutment
- Medical subject headings
- Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutmentProcedure or surgery
Twenty BLXⓇ Straumann immediate implants were placed flapless. The gap around the implant was filled with xenogeneic biomaterial. An intra-oral scanner was performed and sent to the dental laboratory to digitally design a customized healing abutment. The abutment was then milled from a block of PEEK and placed a couple of hours later in the clinic. Three months after implantation, the abutment was removed and the final monolithic crown based on the initial IOS was placed. The transmucosal design from the SSA was replicated on the final crown.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | immediate implant placement in posterior sites using a custom-made sealing socket abutment combined to alveolar ridge preservation Receives: Procedure: Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to 1 year of the bone remodeling : horizontal measurements (based on CBCT, in mm)
The measurements were done by matching and superimposing CBCT using a three dimensional reconstruction software. The measures were performed from implant platform to 7 mm below this reference line. Bucco-palatal remodeling, buccal remodeling and palatal/lingual remodeling were measured
Measured: Baseline to 1, 3 and 5 years
Changes from Baseline to 1 year of the bone remodeling : vertical measurements (based on CBCT, in mm)
The measurements were done by matching and superimposing CBCT using a three dimensional reconstruction software. Four vertical measurements were taken : on the buccal side, on the lingual side, and in mesial and distal of the implant, under the contact points.
Measured: Baseline to 1, 3 and 5 years
Changes from baseline to 6 months and to 1 year of the soft tissue profiles (based on intra-oral scanners, in mm)
Intra-oral scanners were performed at baseline, 6 months and 1 year and were superimposed using a specific software. The buccal and lingual/palatal measurements were done perpendicular to the soft tissue profile at gingival margin and every mm below until 4 mm. The recession was measure as the vertical distance between the gingival margin at the different time points.
Measured: Baseline to 1, 3 and 5 years
Secondary outcomes (6)
implant survival rate (based on criteria of Buser et al., 1990)
Success was defined according to the criteria of Buser et al., 1990 which are 1. absence of suppuration (recurring peri implant infection) 2. absence of persistent complaints like pain, foreign body sensation and/or dysesthesia 3. absence of continuous radioluncency area around the implant 4. absence of implant mobility.
Measured: Baseline to 1, 3 and 5 years
Pocket depth around the implant (based on probing, in mm)
PD was measured by means of a periodontal probe (CP 15 UNC, Hu-Friedy, Chicago, IL, USA) at 6 sites per implant and rounded off to the nearest millimeter.
Measured: Baseline to 1, 3 and 5 years
Peri-implant bone level changes (based on periapical radiography, in mm)
The peri-implant bone levels were assessed on periapical radiography using the parallel technique: the linear distance between the implant shoulder of the bone level implants and the first bone to implant contact (DIB, mm) was measured at the mesial and distal aspects using the specific software Image J64 (National Institutes of Health, Bethesda, MD, USA). Final DIB values were recorded as the average of the obtained mesial and distal values.
Measured: Baseline to 1, 3 and 5 years
Pink esthetic score (based on PES questionnaire of Furhauser et al, 2005)
The PES compares the peri-implant soft tissue conditions to the respective features present at the contralateral natural tooth site. A score of 0, 1 or 2 was assigned to each parameter (mesial and distal papilla, soft tissue contour, soft tissue level, alveolar process, soft tissue coloring and texture), the highest possible score being 14, as described by Fürhauser et al (Fürhauser et al., 2005).
Measured: Baseline to 1, 3 and 5 years
Plaque index around the implant (based on classification of Mombelli et al, 1987)
The plaque index was scored according to Mombelli 1987 (0 = no detection of plaque; 1 = plaque only recognized by running a probe across the smooth marginal surface of the implant, 2 = plaque can be seen by the naked eye, 3 = abundance of soft matter)
Measured: Baseline to 1, 3 and 5 years
Bleeding on Probing around the implant (based on classification of Mombelli et al, 1987)
The bleeding on probing was scored according to Mombelli 1987 (0 = no bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant; 1 = isolated bleeding spots visible, 2 = Blood forms a confluent red line on margin, 3 = heavy or profuse bleeding)
Measured: Baseline to 1, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start22 Aug 2018
- Primary completion30 Jun 2020
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-maintainable Posterior Tooth (Molars and Premolars)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Principal investigator, Dr. France LAMBERT, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553146
- Sponsor's protocol ID
- H2017-BLX
- Status last verified
- Apr 2023
- First submitted
- 4 Sep 2020
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement in the Posterior Region Combining Socket Seal Abutment and Alveolar Ridge Preservation: Implant, Hard and Soft Tissue Outcomes After 1 Year, 3 Years and 5 Years
- ClinicalTrials.gov ID
- NCT04553146
- Acronym / sponsor ID
- H2017-BLX
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 17 Sep 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.
objectives
The aim of this study was to assess the implant outcomes as well as hard and soft tissue dimensional changes of immediate implant placement in posterior sites using a custom-made sealing socket abutment (SSA) combined to alveolar ridge preservation (ARP).
Material and methods
Twenty posterior teeth were immediately replaced with implants in 20 patients. The remaining sockets were filled with Deproteinized Bovine Bone Mineral. Based on intra-oral scanners (IOS), custom-made SSAs were placed the same day. CBCT and IOS were performed to monitor hard and soft tissue dimensional changes. Moreover, implant survival rate, peri-implant bone changes, peri-implant health and pink esthetic score were recorded at 1 year, 3years and 5 years.
Detailed description
Study population
Hopeless maxillary or mandibular molars with tooth anatomy and bone anchorage allowing an immediate implant procedure: apical bone height of at least 5 mm or presence of interradicular septum, socket with intact bone walls, absence a large apical periodontitis, Patients needing tooth replacement in the posterior region (molars) will be recruited from the Department of Periodontology and Oral and Implant Surgery of the University of Liège, Belgium.
Procedures
After a local anesthesia, one of the two experienced surgeons (LF or LG) proceeded to the least traumatic extraction of the concerned tooth. The consecutive drills for implant placement were carried out while considering the future position of the crown for a screw- retained restoration. Twenty BLX implants (Roxolid®, SLAactive®, Institut Straumann AG) were placed flapless with a sufficient apical or septum anchorage and the insertion torque was recorded. The gap around the implant was filled with deproteinized bovine bone mineral (DBBM) (cerabone®, botiss biomaterials GmbH).
Just after the implant placement, an intra-oral scan (IOS) (Trios 3®, 3-Shape) with a scanbody connected onto the implant platform was performed and sent to the dental laboratory to digitally design (Dental Wings®) a customized healing abutment. The SSA was then milled (CARES®, Institut Straumann AG) from a block of PEEK (JUVORATMPEEK, JUVORATM Ltd. National Distributor: Institut Straumann AG), cemented to a titanium abutment (Variobase®, Institut Straumann AG) and provided to the patient on the same day. During manufacturing of the SSA, a conventional healing abutment was screwed on the implant and a collagen sponge (Collaplug®) was provisionally placed buccally to protect the exposed biomaterial until the placement of the SSA. A standardized parallel peri-apical radiograph using a custom-made film holder was taken in order to record the baseline bone level. Each patient was instructed to rinse twice daily with an aqueous solution of 0.2% chlorhexidine (Corsodyl®, GSK) and to avoid brushing of the area until the first recall 10-12 days later. Anti-inflammatories (Ibuprofen® 600 mg) and additional analgesics (Paracetamol® 500 mg) were prescribed and taken according to the patient's needs. If the surgeon deemed it necessary, an anti- biotic was prescribed (Amoxicillin® 500mg 3x/day during 5 days). Three months after implantation, the abutment was removed, the osseointegration of the implant was checked and the final lithium aluminosilicate ceramic reinforced with lithium disilicate monolithic crown (n!ce® glass-ceramic block, Institut Straumann AG) based on the initial IOS was cemented to a titanium abutment (Variobase®, Institut Straumann AG) and placed. The transmucosal design from the SSA was replicated on the final crown. Follow-up evaluations and data recording will be performed 7-10 days, 3 months, 6 months, 12 months, 3years and 5years after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Procedure: Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutmentimmediate implant placement in posterior sites using a custom-made sealing socket abutment combined to alveolar ridge preservation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- good general health (ASA I/II),
- more than 18 years old,
- non smoker,
- one hopeless tooth,
- healthy periodontal condition,
Key exclusion criteria (11 listed)
- auto-immune disease or immunocompromised patients,
- uncontrolled diabetes,
- use of steroids or biphosphonates,
- local or systemic infection (medical treatment needed prior to entrance to the study), pregnancy or breastfeeding, alcoholism or chronically drug abuse.
- bone availability requiring an angulated abutment,
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 |
|---|---|---|
| Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutmentTwenty BLXⓇ Straumann immediate implants were placed flapless. The gap around the implant was filled with xenogeneic biomaterial. An intra-oral scanner was performed and sent to the dental laboratory to digitally design a customized healing abutment. The abutment was then milled from a block of PEEK and placed a couple of hours later in the clinic. Three months after implantation, the abutment was removed and the final monolithic crown based on the initial IOS was placed. The transmucosal design from the SSA was replicated on the final crown. | Procedure or surgery | Interventional arm |
Primary outcome
Changes from baseline to 1 year of the bone remodeling : horizontal measurements (based on CBCT, in mm)
Time frame: Baseline to 1, 3 and 5 years
The measurements were done by matching and superimposing CBCT using a three dimensional reconstruction software. The measures were performed from implant platform to 7 mm below this reference line. Bucco-palatal remodeling, buccal remodeling and palatal/lingual remodeling were measured
Changes from Baseline to 1 year of the bone remodeling : vertical measurements (based on CBCT, in mm)
Time frame: Baseline to 1, 3 and 5 years
The measurements were done by matching and superimposing CBCT using a three dimensional reconstruction software. Four vertical measurements were taken : on the buccal side, on the lingual side, and in mesial and distal of the implant, under the contact points.
Changes from baseline to 6 months and to 1 year of the soft tissue profiles (based on intra-oral scanners, in mm)
Time frame: Baseline to 1, 3 and 5 years
Intra-oral scanners were performed at baseline, 6 months and 1 year and were superimposed using a specific software. The buccal and lingual/palatal measurements were done perpendicular to the soft tissue profile at gingival margin and every mm below until 4 mm. The recession was measure as the vertical distance between the gingival margin at the different time points.
6 secondary outcomes
implant survival rate (based on criteria of Buser et al., 1990)
Time frame: Baseline to 1, 3 and 5 years
Pocket depth around the implant (based on probing, in mm)
Time frame: Baseline to 1, 3 and 5 years
Peri-implant bone level changes (based on periapical radiography, in mm)
Time frame: Baseline to 1, 3 and 5 years
Pink esthetic score (based on PES questionnaire of Furhauser et al, 2005)
Time frame: Baseline to 1, 3 and 5 years
Plaque index around the implant (based on classification of Mombelli et al, 1987)
Time frame: Baseline to 1, 3 and 5 years
Bleeding on Probing around the implant (based on classification of Mombelli et al, 1987)
Time frame: Baseline to 1, 3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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 Phase 4 study testing Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutment in people with Non-maintainable Posterior Tooth (Molars and Premolars), run by University of Liege at 1 site in Belgium.
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 7 inclusion and 11 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 26 Apr 2023. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes from baseline to 1 year of the bone remodeling : horizontal measurements (based on CBCT, in mm) (time frame: Baseline to 1, 3 and 5 years). The study lists 3 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 26 Apr 2023.