Comparison of Incidence Between Two Techniques

Summary

Sinus augmentation, also referred to as a sinus lift or a sinus graft, is an oral surgery procedure where bone is added to the upper jaw near the molars. The goal of the surgery is to add enough bone material onto the upper jaw to support the placement of a dental implant. The augmentation and the dental implant placement will be done at the same time to avoid the need for two surgeries. This is standard of care.

The purpose of this study is to compare any problems and patient comfort levels following surgery. Subjects will be randomly placed into one of two groups: the internal lift group or the external lift group. Both types of surgery are routinely done at our clinic. Usually the type of procedure (internal or external) is based on the dentist's preference. Investigators are doing this study to compare them to each other to see if one is more comfortable for the subject than the other or if they are equal. It is predicted that the two techniques may differ when it comes to complications during the procedure, patient discomfort following the procedure and patient complications in the weeks and months after the procedure. This last comparison has not yet been studied, and surgeons often choose the technique that they prefer from their own experiences. With this research study researchers hope to gain valuable information that will help surgeons' decisions in the future.

* Investigators hypothesize that external sinus augmentation with simultaneous implant placement (external technique) will have a higher rate of Schneiderian membrane perforation than the internal sinus augmentation with simultaneous implant placement (internal technique).
* Investigators hypothesize that the internal technique is associated with more discomfort for the subject compared with the external technique.
* Investigators hypothesize that the external technique will result in more severe pain/bleeding/swelling than the internal technique.
* Investigators hypothesize that the internal technique has a higher incidence of complications that occur between three weeks and three months postoperatively compared with the external technique.
* Investigators hypothesize that the external technique has a higher amount of analgesics taken postoperatively compared with the internal technique

Conditions

• Edentulous Posterior Maxilla

Interventions

PROCEDURE

internal maxillary sinus floor elevation technique

The internal lift procedure uses a drilling instrument (a drill that cuts through bone) to break through the bone for where the implant will later go. This creates an opening in the necessary area to allow more bone material to be added, which will move the sinus up and allow for the implant to be securely placed.

PROCEDURE

external maxillary sinus floor elevation technique

The external lift procedure involves cutting through the upper-most part of the gums to then cut through the bone to create an opening in the necessary area. The sinus will be manually lifted and the bone material will be added, which will allow for the implant to be securely placed.

Sponsors & Collaborators

• Tufts University

  lead OTHER

Principal Investigators

• Yong Hur, DMD MS · TUSDM

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2016-09-30

Completion

2016-12-31

Countries

• United States

Study Locations