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Guided Bone Regeneration Around Immediate Implants

Primary Purpose

Missing Tooth

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Minimally Traumatic Tooth Extraction
Immediate Implant Placement
Bone Graft Placement
Membrane placement
Collagen plug placement
Medications
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Tooth

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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.

Sites / Locations

  • Graduate Periodontics Dept of Periodontics and Oral Medicine University of Michigan - School of Dentistry 1011 N. University, Room 1324

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Membrane

Collagen plug

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Thickness of Buccal Bone
Change of buccal bone volume over study duration

Secondary Outcome Measures

Change in Interproximal Bone Levels
Change of interproximal marginal bone loss (mean of mesial and distal sites)
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.

Full Information

First Posted
June 11, 2012
Last Updated
February 10, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01628367
Brief Title
Guided Bone Regeneration Around Immediate Implants
Official Title
The Effectiveness of the Cytoplast Technique in Preventing Bone Loss Around Immediate Implant Placement in the Esthetic Zone. A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Membrane
Arm Type
Experimental
Arm Description
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.
Arm Title
Collagen plug
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Minimally Traumatic Tooth Extraction
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Immediate Implant Placement
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Bone Graft Placement
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Membrane placement
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Collagen plug placement
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Medications
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Thickness of Buccal Bone
Description
Change of buccal bone volume over study duration
Time Frame
One year
Secondary Outcome Measure Information:
Title
Change in Interproximal Bone Levels
Description
Change of interproximal marginal bone loss (mean of mesial and distal sites)
Time Frame
One year
Title
Pink Esthetic Score
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hom-Lay Wang, DDS,MSD,PhD
Organizational Affiliation
Department of Periodontics and Oral Medicine, The University of Michigan, School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graduate Periodontics Dept of Periodontics and Oral Medicine University of Michigan - School of Dentistry 1011 N. University, Room 1324
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Guided Bone Regeneration Around Immediate Implants

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