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Effects of Bone Graft Placement at Implant Installation on Buccal Plate Stability

NCT01245920 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-08-30

No results posted yet for this study

Summary

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.

Conditions

  • Peri-implant Alveolar Bone Thickness

Interventions

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

Non-FDBA

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

Sponsors & Collaborators

  • Nebraska Society of Periodontology

    collaborator UNKNOWN

  • Creighton University

    lead OTHER

Principal Investigators

  • Melissa S Lang, DDS, MS · Creighton University School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245920 on ClinicalTrials.gov