Effects of Bone Graft Placement at Implant Installation on Buccal Plate Stability - Full Text View

Purpose

This randomized clinical trial will involve at least 25 patients who have selected to receive a dental implant to replace a missing tooth. One group will receive the test treatment of a bone graft and a dissolvable membrane at the outer surface of the dental, while the control group will not receive the bone graft and membrane adjacent to the implant.

The following will be measured: bone thickness and height adjacent to implant, inflammation of gum tissue, recession of gum tissue, bleeding, pocket depth, and implant success. Patients will be followed for 1 year, including evaluation time points at 2 weeks, 1 month, 3 and 6 months, and 1 year. Statistical analysis of the data will be conducted.

The hypothesis is that there is no difference with regard to bone thickness, bone height, pocket depth, bleeding, and implant success rate for grafted implant sites compared to non-grafted implant sites.

Condition	Intervention
Peri-implant Alveolar Bone Thickness	Biological: DFDBA + Bio-Gide Membrane Other: Non-FDBA

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effects of Bone Graft Placement at Implant Installation on Buccal Plate Stability: A Randomized Controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Bone Grafts

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:

Change in Buccal Bone Thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The buccal bone thickness will be measured by recording the distance from the buccal implant surface to the outer buccal bone crest to the nearest 1 mm using a periodontal probe (UNC-15).

Secondary Outcome Measures:

Change in Clinical Attachment Level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The following clinical measurements will be obtained with a plastic periodontal probe at 6 sites at each implant (Colorview, Hu-Friedy, Chicago, IL) and recorded to the nearest millimeter: probing depth and gingival margin position

Enrollment:	0
Study Start Date:	November 2010
Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: FDBA + Membrane Group For patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure.	Biological: DFDBA + Bio-Gide Membrane For patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure. Other Names: Puros bone allograft Bio-Gide membrane
Active Comparator: Non-FDBA Patients in the non-FDBA group will have gingival flaps closed with the same suturing technique.	Other: Non-FDBA Patients in the non-FDBA group will have gingival flaps closed with the same suturing technique.

Arms

Assigned Interventions

Experimental: FDBA + Membrane Group

For patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure.

Biological: DFDBA + Bio-Gide Membrane

For patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure.

Other Names:

Puros bone allograft
Bio-Gide membrane

Active Comparator: Non-FDBA

Patients in the non-FDBA group will have gingival flaps closed with the same suturing technique.

Other: Non-FDBA

Patients in the non-FDBA group will have gingival flaps closed with the same suturing technique.

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Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects willing and able to follow study procedures.
Subjects treatment plan includes the placement of at least one endosseous dental implant in the maxillary or mandibular arch.
Subjects must present with at least 1 mm buccal bone thickness immediately after surgical placement of endosseous dental implant.
Subjects must demonstrate a plaque index of ≤20%.
Subjects who can read, understand, and sign an institutional review board approved informed consent.

Exclusion Criteria:

Subjects with systemic condition including diabetes mellitus, cancer, human immunodeficiency virus, or bone metabolic disease.
Subjects who take corticosteroids, immunosuppressant, bisphosphonates, radiation treatments, and/or chemotherapeutics that could compromise wound healing process.
Subjects with acute infectious lesions in the area of study.
Subjects under 21 years of age.
Subjects with previous failed endosseous dental implant at the site of study.
Smokers.
Subjects with dehiscence of implant surface > 1 mm immediately after surgical placement of endosseous dental implant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245920

Locations

United States, Nebraska
Creighton University School of Dentistry
Omaha, Nebraska, United States, 68178

Sponsors and Collaborators

Creighton University

Nebraska Society of Periodontology

Investigators

Principal Investigator:

Melissa S Lang, DDS, MS

Creighton University School of Dentistry

More Information

No publications provided

Responsible Party:	Melissa S. Lang, DDS, MS, Creighton University
ClinicalTrials.gov Identifier:	NCT01245920 History of Changes
Other Study ID Numbers:	10-15770
Study First Received:	November 19, 2010
Last Updated:	August 28, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

Dental implant
Alveolar bone
Clinical attachment Level

ClinicalTrials.gov processed this record on June 18, 2013