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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02174198

Enrollment

Registered

2014-06-25

Start date

2014-01-31

Completion date

2018-08-31

Last updated

2019-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Loss

Keywords

Immediate implant, bone graft, immediate restoration

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.

Interventions

DEVICEBioOss Collagen at the time of implant placement

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Mean Bucco-Lingual Change at 3mm	Baseline and 12 months	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	Baseline and 12 months	The horizontal dimensional change from a digital superimposition at 4mm apical to the baseline free gingival margin position was measured.

Secondary

Measure	Time frame	Description
Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal)	Baseline and 12 months	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)	Baseline and 12 months	The mean change was calculated from a tooth-supported stent to the free gingival margin.
Periodontal Probing Depth	12 months	The periodontal probing depth will be measured in mm.
Thickness of Keratinized Tissue at 4mm	12 months	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	12 months	Tissue thickness was measured at 8mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.
Thickness of Keratinized Tissue at 3mm	12 months	Tissue thickness was measured at 3mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.
Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla)	Baseline and 12 months	The mean change was calculated from a tooth-supported stent to the free gingival margin.

Countries

United States

Participant flow

Participants by arm

Arm	Count
BioOss Collagen Intervention: BioOss Collagen at the time of implant placement BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen	16
No Bone Graft No placement of BioOss at the time of implant placement	16
Total	32

Baseline characteristics

Characteristic	BioOss Collagen	No Bone Graft	Total
Age, Continuous	52.4 years STANDARD_DEVIATION 4.2	52.3 years STANDARD_DEVIATION 3.3	52.3 years STANDARD_DEVIATION 4
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	8 Participants	12 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants	8 Participants	20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Number of Smokers	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	4 Participants	2 Participants	6 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants	8 Participants	12 Participants
Race (NIH/OMB) White	8 Participants	6 Participants	14 Participants
Sex: Female, Male Female	12 Participants	11 Participants	23 Participants
Sex: Female, Male Male	4 Participants	5 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 16
other Total, other adverse events	0 / 16	0 / 16
serious Total, serious adverse events	0 / 16	0 / 16

Outcome results

Primary

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.