Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

NCT02174198 | Completed Results FDA Device

• 1 other identifier: AAAM4053
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two ways of placing a dental implant on the day of tooth extraction. One method will place a additional bone graft (derived from bovine bone) and the other group will not have the graft placed. Both groups will be restored at the same time with an immediate crown. The investigators will be researching and comparing the changes in gum level that occur after each surgical method, as well as changes in jaw width where the implant is placed. The investigators will enroll 16 patients per group. The patients will be followed for 3, 6, and 12 months post-immediate implant placement to observe healing.

Conditions

Tooth Loss

Keywords

Immediate implant; bone graft; immediate restoration

Outcome Measures

Primary Outcomes (2)

• Mean Bucco-Lingual Change at 3mm

  The horizontal dimensional change from a digital superimposition at 3mm apical to the baseline free gingival margin position was measured.

  Baseline and 12 months

• Mean Bucco-Lingual Change at 4mm

  The horizontal dimensional change from a digital superimposition at 4mm apical to the baseline free gingival margin position was measured.

  Baseline and 12 months

Secondary Outcomes (7)

• Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla)

  Baseline and 12 months

• Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal)

  Baseline and 12 months

• Change in Vertical Dimension of Buccal Soft Tissue (Mesial Papilla)

  Baseline and 12 months

• Periodontal Probing Depth

  12 months

• Thickness of Keratinized Tissue at 3mm

  12 months

Study Arms (2)

BioOss Collagen

EXPERIMENTAL

Intervention: BioOss Collagen at the time of implant placement

Device: BioOss Collagen at the time of implant placement

No Bone Graft

NO INTERVENTION

No placement of BioOss at the time of implant placement

Interventions

BioOss Collagen at the time of implant placement DEVICE

Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen

Also known as: BioOss Collagen, Geistlich Pharma Inc.

BioOss Collagen

Eligibility Criteria

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

You may qualify if:

• Subject must have read, understood and signed an informed consent form.
• Subjects must be willing and able to follow study procedures and instructions.
• Subjects must have labial plate of bone present after extraction no more than 4 mm from the free gingival margin.
• Subjects must require one maxillary anterior implant.
• Subjects must be older than 18 years

You may not qualify if:

• Subjects having participated within the last six months in other clinical studies.
• Subjects who have failed to maintain good plaque control.
• Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, human immunodeficiency virus (HIV), disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery.
• Subjects with the presence of acute infectious lesions in the areas intended for surgery.
• History within the last 6 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day).
• Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
• Subjects on Bisphosphonate Therapy with C-terminal telopeptide (CTX) values \<100
• Subjects requiring antibiotic prophylaxis for subacute bacterial endocarditis (SBE) or late prosthetic joint infection. Patients who cannot undergo standard oral surgery procedure for any reason.
• Subjects that have adjacent teeth next to tooth slated for extraction and immediate placement showing periodontal disease, endodontic and/or caries pathology will be excluded.
• Subjects having unfavorable occlusal schemes for immediate loading, parafunctional habits and inadequate posterior support to properly protect the anterior teeth during function.
• Implant site will not be next to an adjacent implant.

Sponsors & Collaborators

• Columbia University: lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

Columbia University, College of Dental Medicine

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Limitations and Caveats

The sample size for this study is limited, as well as the overall follow up of the patients. Further, studies with longer follow up times may be recommended to evaluate long term behavior of the tissues with immediately placed implants.

Results Point of Contact

• Title: Nurit Bittner, DDS, MS, Dip.ABP
• Organization: Columbia University

nb2203@cumc.columbia.edu

212-342-2763

Study Officials

• Nurit Bittner Fogel, DDS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dental Medicine

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 25, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: June 13, 2019
• Results First Posted: June 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)