Missing ToothPhase 4NCT01628367
Guided Bone Regeneration Around Immediate Implants
A Phase 4 study testing Minimally Traumatic Tooth Extraction, Immediate Implant Placement and Bone Graft Placement in people with Missing Tooth, run by University of Michigan at 1 site in United States.
Trial summary
An important result of healing after tooth extraction is a reduction in dimensions of the remaining bone at that site. This reduction of bone volume precludes successful restoration of the space using a dental implant. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Tooth
- What is being tested?
- Minimally Traumatic Tooth Extraction, Immediate Implant Placement and Bone Graft Placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 18 or older.
- Systemically healthy (American Society of Anesthesiologists I or II).
- Subjects will have one or more anterior or premolar teeth with a hopeless prognosis, with adjacent and opposing teeth present.
- Compliance with all requirements in the study and signing the informed consent
Who cannot join
- Active acute infection at the extraction site (e.g., sinus tract, swelling)
- Absence of sufficient mesio-distal width to place an implant as per the study protocol.
- Absence of sufficient bone height to house a 10mm long implant.
- The subject lacks a stable occlusion and/or a healthy periodontium.
- Current smokers or quit smoking less than one year
- Chronic use of medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications)
Show all 14Show fewer
- Pregnancy or lactating mothers
- Current orthodontic or periodontal treatments
- History of alcoholism or drug abuse
- Untreated deep carious lesions or defective restorations that can potentially exacerbate during the course of the study
- Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >7)
- Bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease)
- Neurologic or psychiatric disorders, systemic infections
- A history of IV bisphosphonate use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate Periodontics Dept of Periodontics and Oral Medicine University of Michigan - School of Dentistry 1011 N. University, Room 1324
Ann Arbor, Michigan, 48109
About this study
Official title: The Effectiveness of the Cytoplast Technique in Preventing Bone Loss Around Immediate Implant Placement in the Esthetic Zone. A Randomized Clinical Trial.
An important result of healing after tooth extraction is a reduction in dimensions of the remaining bone at that site. This reduction of bone volume precludes successful restoration of the space using a dental implant. Bone augmentation has shown promise in clinical reports to reduce this loss of bone volume, thus allowing implant placement and restoration. The purpose of this study is to evaluate the clinical and radiographic outcomes of guided bone regeneration around dental implants placed in fresh extraction sockets.
Read the detailed description
Aim: The purpose of this clinical study is to investigate the effect of a non-resorbable polytetrafluoroethylene (PTFE) membrane on immediate implant placement in the esthetic zone.
Material and Methods: Systemically healthy subjects presenting with a hopeless tooth in the maxillary premolar or anterior region will be recruited in the study. Following a minimally traumatic tooth extraction, subjects will be randomly distributed into one of two treatment groups, a Membrane (Test) or a No Membrane (Control) group. Both groups will receive immediate placement of an implant along with placement of a bone graft material to fill the spaces around the implant. Sites in the test group will receive a non-resorbable PTFE membrane over the socket, whereas those in the control group will receive a collagen dressing over the socket. At sites in the test group, the membrane will be removed at 4 weeks. A second stage surgery and placement of a provisional restoration will be carried out 4 months after implant placement. Final restorations will be placed 3 months after placement of the provisional restoration. Clinical and radiographic measurements will be performed at baseline, implant placement, placement of provisional and final restorations and at the 5-month recall visit.
- Conditions
- Missing Tooth
- Being tested
- Minimally Traumatic Tooth Extraction, Immediate Implant Placement, Bone Graft Placement, Membrane placement, Collagen plug placement
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Traumatic Tooth ExtractionProcedure or surgery
The surgeon will perform a minimally traumatic tooth extraction in the following fashion. Intrasulcular incisions will be performed with at 15-C scalpel around the tooth to be extracted.
A periotome will then be introduced into the periodontal ligament space in order to sever the subcrestal attachment and expand the periodontal ligament space. Elevators will be used to initiate luxation of teeth. After significant mobility has been achieved through elevation, forceps will be used only to deliver the tooth. Finally, the socket will be curetted to remove all granulomatous tissue and irrigated with sterile isotonic saline solution.
Immediate Implant PlacementDevice
A threaded titanium alloy implant with an internal hex connection and a Resorbable Blast Texturing (RBT) surface (Tapered Internal® Implant System, Biohorizons, Inc., Birmingham, AL, USA) will be placed using a surgical guide. Implant diameter of 3.8mm with lengths of either 12 or 15mm will be used. Implants will be placed approximately 3-4mm below the free gingival margin or 2-3mm below the cemento-enamel junction of adjacent teeth.
Bone Graft PlacementBiological
Circumferential defects or dehiscences around the immediately placed implant will be grafted. enCore™ Combination Allograft (Osteogenics Biomedical, Lubbock, Texas, USA) will be used as the bone graft material.
Membrane placementBiological
A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area.
Collagen plug placementBiological
A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket
MedicationsDrug
Patients will be given amoxicillin 500mg 2 days prior to the surgery and will then continue for every 8 hours for 10 days. Patients will also take Ibuprofen 600mg every 6 hours for the first 3 days following the surgery, and then as needed for pain. Patients will also receive a prescription for Vicodin as needed for pain, every 4 to 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Membrane | Experimental | Test (membrane): Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket. Receives: Procedure: Minimally Traumatic Tooth Extraction; Device: Immediate Implant Placement; Biological: Bone Graft Placement; Biological: Membrane placement; Drug: Medications |
| Collagen plug | Active comparator | Control (collagen plug): Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket. Receives: Procedure: Minimally Traumatic Tooth Extraction; Device: Immediate Implant Placement; Biological: Bone Graft Placement; Biological: Collagen plug placement; Drug: Medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Thickness of Buccal Bone
Change of buccal bone volume over study duration
Measured: One year
Secondary outcomes (2)
Change in Interproximal Bone Levels
Change of interproximal marginal bone loss (mean of mesial and distal sites)
Measured: One year
Pink Esthetic Score
Pink esthetic score per Furhauser et.al. measured at study conclusion where based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture (Fig. 1). Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. Thus a maximum score of 14 is best, and 0 is the worst.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Missing ToothStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
- Investigators
- Hom-Lay Wang, DDS,MSD,PhD, Principal investigator, Department of Periodontics and Oral Medicine, The University of Michigan, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628367
- Sponsor's protocol ID
- HUM00050746
- Status last verified
- Feb 2017
- First submitted
- 11 Jun 2012
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Cytoplast Technique in Preventing Bone Loss Around Immediate Implant Placement in the Esthetic Zone. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01628367
- Acronym / sponsor ID
- HUM00050746
- Conditions
- Missing Tooth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Posted 10 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An important result of healing after tooth extraction is a reduction in dimensions of the remaining bone at that site. This reduction of bone volume precludes successful restoration of the space using a dental implant. Bone augmentation has shown promise in clinical reports to reduce this loss of bone volume, thus allowing implant placement and restoration. The purpose of this study is to evaluate the clinical and radiographic outcomes of guided bone regeneration around dental implants placed in fresh extraction sockets.
Detailed description
Aim: The purpose of this clinical study is to investigate the effect of a non-resorbable polytetrafluoroethylene (PTFE) membrane on immediate implant placement in the esthetic zone.
Material and Methods: Systemically healthy subjects presenting with a hopeless tooth in the maxillary premolar or anterior region will be recruited in the study. Following a minimally traumatic tooth extraction, subjects will be randomly distributed into one of two treatment groups, a Membrane (Test) or a No Membrane (Control) group. Both groups will receive immediate placement of an implant along with placement of a bone graft material to fill the spaces around the implant. Sites in the test group will receive a non-resorbable PTFE membrane over the socket, whereas those in the control group will receive a collagen dressing over the socket. At sites in the test group, the membrane will be removed at 4 weeks. A second stage surgery and placement of a provisional restoration will be carried out 4 months after implant placement. Final restorations will be placed 3 months after placement of the provisional restoration. Clinical and radiographic measurements will be performed at baseline, implant placement, placement of provisional and final restorations and at the 5-month recall visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Membrane | Experimental | Procedure: Minimally Traumatic Tooth Extraction, Device: Immediate Implant Placement, Biological: Bone Graft Placement, Biological: Membrane placement, Drug: MedicationsTest (membrane): Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket. |
| Collagen plug | Active comparator | Procedure: Minimally Traumatic Tooth Extraction, Device: Immediate Implant Placement, Biological: Bone Graft Placement, Biological: Collagen plug placement, Drug: MedicationsControl (collagen plug): Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females aged 18 or older.
- Systemically healthy (American Society of Anesthesiologists I or II).
- Subjects will have one or more anterior or premolar teeth with a hopeless prognosis, with adjacent and opposing teeth present.
- Compliance with all requirements in the study and signing the informed consent
Key exclusion criteria (14 listed)
- Active acute infection at the extraction site (e.g., sinus tract, swelling)
- Absence of sufficient mesio-distal width to place an implant as per the study protocol.
- Absence of sufficient bone height to house a 10mm long implant.
- The subject lacks a stable occlusion and/or a healthy periodontium.
- Current smokers or quit smoking less than one year
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 |
|---|---|---|
| Minimally Traumatic Tooth ExtractionThe surgeon will perform a minimally traumatic tooth extraction in the following fashion. Intrasulcular incisions will be performed with at 15-C scalpel around the tooth to be extracted. A periotome will then be introduced into the periodontal ligament space in order to sever the subcrestal attachment and expand the periodontal ligament space. Elevators will be used to initiate luxation of teeth. After significant mobility has been achieved through elevation, forceps will be used only to deliver the tooth. Finally, the socket will be curetted to remove all granulomatous tissue and irrigated with sterile isotonic saline solution. | Procedure or surgery | Collagen plug, Membrane |
| Immediate Implant PlacementA threaded titanium alloy implant with an internal hex connection and a Resorbable Blast Texturing (RBT) surface (Tapered Internal® Implant System, Biohorizons, Inc., Birmingham, AL, USA) will be placed using a surgical guide. Implant diameter of 3.8mm with lengths of either 12 or 15mm will be used. Implants will be placed approximately 3-4mm below the free gingival margin or 2-3mm below the cemento-enamel junction of adjacent teeth. | Device | Collagen plug, Membrane |
| Bone Graft PlacementCircumferential defects or dehiscences around the immediately placed implant will be grafted. enCore™ Combination Allograft (Osteogenics Biomedical, Lubbock, Texas, USA) will be used as the bone graft material. | Biological | Collagen plug, Membrane |
| Membrane placementA non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area. | Biological | Membrane |
| Collagen plug placementA bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket | Biological | Collagen plug |
| MedicationsPatients will be given amoxicillin 500mg 2 days prior to the surgery and will then continue for every 8 hours for 10 days. Patients will also take Ibuprofen 600mg every 6 hours for the first 3 days following the surgery, and then as needed for pain. Patients will also receive a prescription for Vicodin as needed for pain, every 4 to 6 hours | Drug | Collagen plug, Membrane |
Primary outcome
Change in Thickness of Buccal Bone
Time frame: One year
Change of buccal bone volume over study duration
2 secondary outcomes
Change in Interproximal Bone Levels
Time frame: One year
Pink Esthetic Score
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Hom-Lay Wang, DDS,MSD,PhD principal investigator
Department of Periodontics and Oral Medicine, The University of Michigan, School of Dentistry
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 Minimally Traumatic Tooth Extraction, Immediate Implant Placement and Bone Graft Placement in people with Missing Tooth, run by University of Michigan at 1 site in United States.
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 14 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 20 Mar 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Thickness of Buccal Bone (time frame: One year). 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 20 Mar 2017.