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Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

Primary Purpose

Tooth Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BioOss Collagen at the time of implant placement

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring Immediate implant, bone graft, immediate restoration

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Columbia University, College of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BioOss Collagen

No Bone Graft

Arm Description

Intervention: BioOss Collagen at the time of implant placement

No placement of BioOss at the time of implant placement

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

The mean change was calculated from a tooth-supported stent to the free gingival margin.

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

The mean change was calculated from a tooth-supported stent to the free gingival margin.

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

The mean change was calculated from a tooth-supported stent to the free gingival margin.

Periodontal Probing Depth

The periodontal probing depth will be measured in mm.

Thickness of Keratinized Tissue at 3mm

Tissue thickness was measured at 3mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.

Thickness of Keratinized Tissue at 4mm

Tissue thickness was measured at 4mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.

Thickness of Keratinized Tissue at 8mm

Tissue thickness was measured at 8mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.

Full Information

NCT ID

NCT02174198

First Posted

June 23, 2014

Last Updated

May 22, 2019

Sponsor

Columbia University

Collaborators

Geistlich Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT02174198

Brief Title

Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

Official Title

The Esthetic Effect of Bio-OSS Collagen® on the Mid-facial Gingival Dimensions When Placed Into Gaps Between 3i® Implants Placed Into Fresh Extraction Sockets and the Labial Plate of Bone

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

January 2014 (Actual)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

Geistlich Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The purpose of the current study is to evaluate the soft tissue dimensional changes after extraction of teeth in the esthetic zone, when combined with the placement of implants into these fresh extraction sockets. In addition, the effect of placing a graft material, such as Bio-Oss Collagen® into the gap between implant and the labial plate of bone will be evaluated after an immediately loaded provisional restoration is placed. 32 subjects will have an immediate dental implant placed in the maxillary anterior region (#4-12) after extraction of a hopeless tooth. 16 subjects will be randomly selected to receive Bio-Oss Collagen® (Test group) and 16 subjects will have no graft (Control group) in the gap between the implant and the labial plate of bone. Hopeless maxillary anterior teeth will be extracted and implants will be placed in a flapless procedure. Implants will be immediately loaded with provisional restorations once determined that the implant is stable. Changes in vertical height and horizontal dimensional changes of the free gingival margins will be evaluated at 3, 6, and 12 months post-immediate implant placement.

6. Conditions and Keywords

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

Tooth Loss

Keywords

Immediate implant, bone graft, immediate restoration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BioOss Collagen

Arm Type

Experimental

Arm Description

Intervention: BioOss Collagen at the time of implant placement

Arm Title

No Bone Graft

Arm Type

No Intervention

Arm Description

No placement of BioOss at the time of implant placement

Intervention Type

Device

Intervention Name(s)

BioOss Collagen at the time of implant placement

Other Intervention Name(s)

BioOss Collagen, Geistlich Pharma Inc.

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Bucco-Lingual Change at 3mm

Description

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

Time Frame

Baseline and 12 months

Title

Mean Bucco-Lingual Change at 4mm

Description

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

Time Frame

Baseline and 12 months

Secondary Outcome Measure Information:

Title

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

Description

The mean change was calculated from a tooth-supported stent to the free gingival margin.

Time Frame

Baseline and 12 months

Title

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

Description

The mean change was calculated from a tooth-supported stent to the free gingival margin.

Time Frame

Baseline and 12 months

Title

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

Description

The mean change was calculated from a tooth-supported stent to the free gingival margin.

Time Frame

Baseline and 12 months

Title

Periodontal Probing Depth

Description

The periodontal probing depth will be measured in mm.

Time Frame

12 months

Title

Thickness of Keratinized Tissue at 3mm

Description

Tissue thickness was measured at 3mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.

Time Frame

12 months

Title

Thickness of Keratinized Tissue at 4mm

Description

Tissue thickness was measured at 4mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.

Time Frame

12 months

Title

Thickness of Keratinized Tissue at 8mm

Description

Tissue thickness was measured at 8mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nurit Bittner Fogel, DDS

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University, College of Dental Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

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