Guided Bone Regeneration Around Immediate Implants

Phase 4

Completed

• Conditions: Missing Tooth
• Interventions: Procedure: Minimally Traumatic Tooth Extraction; Device: Immediate Implant Placement; Biological: Bone Graft Placement; Biological: Membrane placement; Biological: Collagen plug placement; Drug: Medications

• Registration Number: NCT01628367
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-26
• Study Start: 2012-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2016-12-20
• Results First Submitted QC: 2016-12-20
• Status Verified: 2017-02
• Results First Posted: 2017-02-10
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen plug	Immediate Implant Placement	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.
Membrane	Medications	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.
Membrane	Bone Graft Placement	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.
Membrane	Membrane placement	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.
Collagen plug	Medications	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.
Membrane	Minimally Traumatic Tooth Extraction	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.
Membrane	Immediate Implant Placement	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.
Collagen plug	Minimally Traumatic Tooth Extraction	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.
Collagen plug	Bone Graft Placement	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.
Collagen plug	Collagen plug placement	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.

Primary Outcome Measures

Name	Time	Method
Change in Thickness of Buccal Bone	One year	Change of buccal bone volume over study duration

Secondary Outcome Measures

Name	Time	Method
Pink Esthetic Score	One year	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.
Change in Interproximal Bone Levels	One year	Change of interproximal marginal bone loss (mean of mesial and distal sites)

Trial Locations

Locations (1)

Graduate Periodontics Dept of Periodontics and Oral Medicine University of Michigan - School of Dentistry 1011 N. University, Room 1324; 🇺🇸 Ann Arbor, Michigan, United States