Guided Bone Regeneration Around Immediate Implants

NCT01628367 | Completed Phase 4 Results DMC

• 1 other identifier: HUM00050746
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Missing Tooth

Outcome Measures

Primary Outcomes (1)

• Change in Thickness of Buccal Bone

  Change of buccal bone volume over study duration

  One year

Secondary Outcomes (2)

• Change in Interproximal Bone Levels

  One year

• Pink Esthetic Score

  One year

Study Arms (2)

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.

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.

Procedure: Minimally Traumatic Tooth Extraction; Device: Immediate Implant Placement; Biological: Bone Graft Placement; Biological: Collagen plug placement; Drug: Medications

Interventions

Minimally Traumatic Tooth Extraction PROCEDURE

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.

Collagen plug; Membrane

Immediate Implant Placement DEVICE

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.

Collagen plug; Membrane

Bone Graft Placement BIOLOGICAL

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.

Collagen plug; Membrane

Membrane placement BIOLOGICAL

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.

Membrane

Collagen plug placement BIOLOGICAL

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

Collagen plug

Medications DRUG

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

Collagen plug; Membrane

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

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

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Anodontia

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Dr. Hom-Lay Wang
• Organization: University of Michigan

homlay@umich.edu

734-647-6175

Study Officials

• Hom-Lay Wang, DDS,MSD,PhD

  Department of Periodontics and Oral Medicine, The University of Michigan, School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Graduate Periodontics

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 26, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 20, 2017
• Results First Posted: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)