Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Loss
• Intervention / Treatment: Device: BioOss Collagen at the time of implant placement

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University, College of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects having participated within the last six months in other clinical studies.
2. Subjects who have failed to maintain good plaque control.
3. 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.
4. Subjects with the presence of acute infectious lesions in the areas intended for surgery.
5. 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).
6. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
7. Subjects on Bisphosphonate Therapy with C-terminal telopeptide (CTX) values <100
8. 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.
9. 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.
10. Subjects having unfavorable occlusal schemes for immediate loading, parafunctional habits and inadequate posterior support to properly protect the anterior teeth during function.
11. Implant site will not be next to an adjacent implant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioOss Collagen; Intervention: BioOss Collagen at the time of implant placement	Device: BioOss Collagen at the time of implant placement; Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen; Other Names: BioOss Collagen, Geistlich Pharma Inc.
No Intervention: No Bone Graft; No placement of BioOss at the time of implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 12 months
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.	Baseline and 12 months
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.	Baseline and 12 months
Periodontal Probing Depth	The periodontal probing depth will be measured in mm.	12 months
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.	12 months
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Geistlich Pharma AG
• Investigators: Principal Investigator: Nurit Bittner Fogel, DDS, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 25, 2014

Study Record Updates

• Last Update Posted (Actual): June 13, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: bone graft; Immediate implant; immediate restoration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: AAAM4053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No