Comparison of Incidence Between Two Techniques

NCT01832025 | Completed

• 2 other identifiers: TUSDM1066510665
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intraoperative; postoperative; complications; discomfort; external; internal; maxillary; elevation; implant; reconstruction; bone; sinus

Outcome Measures

Primary Outcomes (1)

• Compare incidence of Schneiderian membrane perforation

  Compare the incidence of Schneiderian membrane perforation involving sinus augmentation interventions - external and internal technique with simultaneous implant placement.

  1-3 months after surgical procedure

Secondary Outcomes (6)

• Compare discomfort

  1-3 months after surgical procedure

• Compare long term complications

  3 weeks to 3 months after surgical procedure

• Compare the amount of analgesic taken postoperatively

  1-3 months after surgical procedure

• Compare pain

  1 week after surgical procedure

• Compare Bleeding

  One week after surgical procedure

Study Arms (2)

Internal

ACTIVE COMPARATOR

internal maxillary sinus floor elevation technique with simultaneous implant placement

Procedure: internal maxillary sinus floor elevation technique

External

ACTIVE COMPARATOR

external maxillary sinus floor elevation technique with simultaneous implant placement

Procedure: external maxillary sinus floor elevation technique

Interventions

internal maxillary sinus floor elevation technique PROCEDURE

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.

Internal

external maxillary sinus floor elevation technique PROCEDURE

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.

External

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• patients treatment planned for sinus lift augmentation and implant placement, with a height of the crestal alveolar bone measured in the middle of the edentulous space between four and six mm (calibrated measurements recorded on existing panoramic radiograph)
• the length of the edentulous span is one or two teeth
• non-smokers

You may not qualify if:

• patients who have had a previous sinus lift augmentation procedure
• pathology present within the sinus (sinusitis, polyps, neoplasia, mucoceles, etc.) or any deformity/radiation therapy to the sinus
• medically compromised patients contraindicated to dental surgery at TUSDM periodontal clinic including uncontrolled diabetes (HbA1c ≥7, lab results from within the past 6 months will be reviewed, patient without lab results from within the past 6 months will be excluded) and/or uncontrolled hypertension (more than stage II, ≥160/110)
• patients with medical condition that could potentially affect wound healing (e.g., self-reported Hepatitis B or C, self-reported HIV)
• patients with metabolic bone disease such as Paget's Disease or osteoporosis
• patients who are currently taking bisphosphonates or steroids
• patients who are currently pregnant according to self-report (standard of care in the TUSDM Periodontology clinic for such procedures)
• current smokers

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yong Hur, DMD MS

  TUSDM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 15, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)