Immediate ImplantsNCT04737525
Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) After Immediate Placement
A study testing Dental implant placement, bone and soft tissue augmentation on buccal site in people with Immediate Implants, run by Vilniaus Implantologijos Centro (VIC) Klinika at 1 site in Lithuania.
Trial summary
Esthetic outcome of immediate implant placement in fresh extraction sockets remains one of the biggest challenges in implant dentistry. Recently a method to preserve the peri-implant tissues was introduced using provisional restoration, allogenic bone and soft tissue thickening. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immediate Implants
- What is being tested?
- Dental implant placement, bone and soft tissue augmentation on buccal site
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Aug 2017to 10 Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Males and females of at least 18 years of age
- 1 implant per patient
- Subject must have voluntarily signed the informed consent before any study related action, are willing and able to attend scheduled follow-up visits, and agree that the pseudonymized data will be collected and analyzed
- Anterior single teeth (canines and incisors) in both jaws
- Class I extraction socket (intact buccal wall) or Class II (1/3 of buccal wall)
- No recession of gingival contour of tooth to be extracted
Show all 9Show fewer
- No periodontal bone loss of neighboring anterior teeth
- No implants in neighboring teeth
- Atraumatic extraction of the tooth with intact socket walls remaining
Who cannot join
- Deep bite (severe II class)
- Heavy smokers (more than 10 cigarettes/day)
- Systemic disease (diabetes, osteoporosis)
- Primary stability after implant placement not achieved
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of a Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) on the Aesthetic Outcome After Immediate Placement and Loading of a Tapered Dental Implant in the Anterior Maxilla. A Randomized Controlled Clinical Trial.
Esthetic outcome of immediate implant placement in fresh extraction sockets remains one of the biggest challenges in implant dentistry. Recently a method to preserve the peri-implant tissues was introduced using provisional restoration, allogenic bone and soft tissue thickening. However, the evidence that this immediate provisialisation with soft tissue grafting using different grafting materials results in constantly high Pink Esthetic scores, especially compared to the delayed loading approach is still lacking.
The aim of this clinical trial is to assess the esthetic outcome of immediate temporization of immediately placed and loaded tapered implants in fresh extraction sockets with bone and soft tissue augmentation, using either a connective tissue graft (CTG) or a porcine-derived membrane (Mucoderm) in maxillary anterior sites.
The secondary objectives are to investigate the influence of immediate loading on the success rate of tapered implants and crestal bone levels.
- Conditions
- Immediate Implants
- Being tested
- Dental implant placement, bone and soft tissue augmentation on buccal site
- Keywords
- Soft tissue grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placement, bone and soft tissue augmentation on buccal siteDevice
- Atraumatic extraction
- Palatinal positioning of tapered implant (BLX) 3.75mm diameter
- 3-4 mm below vestibular gingival line or 1 mm below bone crest
- Implant placement
- Allogenic bone packing of the "jumping distance" and soft tissue grafting
- Connective tissue graft (CTG) or porcine-derived membrane
- Provisional restoration out of occlusion and mandibular movements
- X-ray
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Immediate implant placement and temporization of tapered implants after tooth extraction with buccal augmentation using allogenic bone and porcine-derived membrane. Receives: Device: Dental implant placement, bone and soft tissue augmentation on buccal site |
| Control group | Experimental | Immediate implant placement and temporization of tapered implants after tooth extraction with buccal augmentation using allogenic bone and connective tissue grafting (CTG). Receives: Device: Dental implant placement, bone and soft tissue augmentation on buccal site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic evaluation
Pink esthetic score (PES) according to Fürhauser et al. 2005 Seven variables will be evaluated: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14. For the PES assessment, frontal photographs will be taken using a digital camera with a flash strobe mounted on a tripod (Canon 350d, 3456×2304 pixel resolution). PES will be assessed at baseline (Final Prosthesis), 3- and 12-month visit.
Measured: Change from baseline, 1 year, 5 and 10 years after prosthetic delivery
Secondary outcomes (1)
Recession of gingiva (REC)
Position of the gingival/mucosal margin - recorded with a periodontal probe from the incisal edge to the margin at the zenith.
Measured: Change from baseline, 1 year, 5 and 10 years after prosthetic delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Aug 2017
- Primary completion31 Dec 2019
- Study completion10 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate ImplantsStudies 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
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilniaus Implantologijos Centro (VIC) Klinika
- Sponsor type
- Research network
- Collaborators
- Straumann Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737525
- Sponsor's protocol ID
- IIS1418
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) on the Aesthetic Outcome After Immediate Placement and Loading of a Tapered Dental Implant in the Anterior Maxilla. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04737525
- Acronym / sponsor ID
- IIS1418
- Conditions
- Immediate Implants
- Keywords
- Soft tissue grafting
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vilniaus Implantologijos Centro (VIC) KlinikaResearch network
- Collaborators
- Straumann Group
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 10 Feb 2031 (estimated)
- First posted
- 4 Feb 2021 (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.
Esthetic outcome of immediate implant placement in fresh extraction sockets remains one of the biggest challenges in implant dentistry. Recently a method to preserve the peri-implant tissues was introduced using provisional restoration, allogenic bone and soft tissue thickening. However, the evidence that this immediate provisialisation with soft tissue grafting using different grafting materials results in constantly high Pink Esthetic scores, especially compared to the delayed loading approach is still lacking.
The aim of this clinical trial is to assess the esthetic outcome of immediate temporization of immediately placed and loaded tapered implants in fresh extraction sockets with bone and soft tissue augmentation, using either a connective tissue graft (CTG) or a porcine-derived membrane (Mucoderm) in maxillary anterior sites.
The secondary objectives are to investigate the influence of immediate loading on the success rate of tapered implants and crestal bone levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Dental implant placement, bone and soft tissue augmentation on buccal siteImmediate implant placement and temporization of tapered implants after tooth extraction with buccal augmentation using allogenic bone and porcine-derived membrane. |
| Control group | Experimental | Device: Dental implant placement, bone and soft tissue augmentation on buccal siteImmediate implant placement and temporization of tapered implants after tooth extraction with buccal augmentation using allogenic bone and connective tissue grafting (CTG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females of at least 18 years of age
- 1 implant per patient
- Subject must have voluntarily signed the informed consent before any study related action, are willing and able to attend scheduled follow-up visits, and agree that the pseudonymized data will be collected and analyzed
- Anterior single teeth (canines and incisors) in both jaws
- Class I extraction socket (intact buccal wall) or Class II (1/3 of buccal wall)
Key exclusion criteria (5 listed)
- Deep bite (severe II class)
- Heavy smokers (more than 10 cigarettes/day)
- Systemic disease (diabetes, osteoporosis)
- Primary stability after implant placement not achieved
- Pregnancy
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 |
|---|---|---|
| Dental implant placement, bone and soft tissue augmentation on buccal site1. Atraumatic extraction 2. Palatinal positioning of tapered implant (BLX) 3.75mm diameter 3. 3-4 mm below vestibular gingival line or 1 mm below bone crest 4. Implant placement 5. Allogenic bone packing of the "jumping distance" and soft tissue grafting 6. Connective tissue graft (CTG) or porcine-derived membrane 7. Provisional restoration out of occlusion and mandibular movements 8. X-ray | Device | Control group, Test group |
Primary outcome
Aesthetic evaluation
Time frame: Change from baseline, 1 year, 5 and 10 years after prosthetic delivery
Pink esthetic score (PES) according to Fürhauser et al. 2005 Seven variables will be evaluated: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14. For the PES assessment, frontal photographs will be taken using a digital camera with a flash strobe mounted on a tripod (Canon 350d, 3456×2304 pixel resolution). PES will be assessed at baseline (Final Prosthesis), 3- and 12-month visit.
1 secondary outcome
Recession of gingiva (REC)
Time frame: Change from baseline, 1 year, 5 and 10 years after prosthetic delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- 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 Dental implant placement, bone and soft tissue augmentation on buccal site in people with Immediate Implants, run by Vilniaus Implantologijos Centro (VIC) Klinika at 1 site in Lithuania.
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 9 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2021. 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 Lithuania. 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?
This study is still under way. Results are not available in the source record yet.
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?
Aesthetic evaluation (time frame: Change from baseline, 1 year, 5 and 10 years after prosthetic delivery). 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 4 Feb 2021.