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NCT01832025 · ClinicalTrials.gov registry record · NA

Comparison of Incidence Between Two Techniques

A NA study, sponsored by Tufts University.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT01832025: Completed NA study, sponsored by Tufts University.

NCT01832025 is a NA study that has completed, run by Tufts University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01832025, a NA study, has completed, sponsored by Tufts University.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study 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 tec

Primary Outcome

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

Interventions

  • PROCEDURE internal maxillary sinus floor elevation technique
  • PROCEDURE external maxillary sinus floor elevation technique

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2013-03
Est. Completion 2016-12
Phase NA
Tufts University

163 total trials

What the finished NCT01832025 record still lists

NCT01832025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which internal maxillary sinus floor elevation technique is the first listed.

NCT01832025 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01832025 about?

NCT01832025 is a clinical study titled "Comparison of Incidence Between Two Techniques". 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 d...

What is the current status of trial NCT01832025?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2013-03. Estimated completion is 2016-12.

What interventions are being tested in trial NCT01832025?

The interventions under investigation include: internal maxillary sinus floor elevation technique (PROCEDURE), external maxillary sinus floor elevation technique (PROCEDURE).

Who is sponsoring clinical trial NCT01832025?

This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01832025's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01832025, the US trial registry maintained by the National Library of Medicine. NCT01832025 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.