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The goal of this observational study is to compare two techniques routinely used to increase bone volume in the jaw prior to placing a dental implant, called osseocondensation and osseodensification. The study participants are healthy adults who are planning to get a dental implant. The main questions it aims to answer are:
It is important to note that the research study will not affect what treatment the participants get. The choice of which technique to use will be made by the dentist who is treating them, based on their clinical judgement. The researchers will only compare the outcomes for the techniques.
For the research study, participants will undergo additional clinical measurements besides those done as the normal post-operative checks, and will fill out questionnaires about their experiences with the procedures. Getting the bone-increasing procedure and getting the dental implant are not part of the research study.
Osseocondensation procedure is a surgical technique developed as an alternative to direct sinus lifting, and it is mainly involved in preparing an implant bed without performing any ostectomy. This is a technique preferred to allow the placement of longer and larger dental implants, especially in posterior upper jaws. The target is to increase the density and the volume of the spongiosa bone at apical-coronal and buccal-lingual dimensions through compression. Although success of this surgical technique has been reported through clinical studies and case reports, some complications such as vertigo have been also documented. Osseodensification technique has been recently developed as an alternative to osseocondensation. This technique uses a special drilling protocol in which the bur turns anti-clockwise and pushes the bone into the trabeculated space instead of using an osteotome. There are several in vitro, in vivo, and clinical studies exploring integrity of bone-implant interface following implant placement through osseodensification technique. However, to the investigators' knowledge, there are no clinical studies comparing this procedure to bone condensation through conventional osteotome technique. Thus, the aim of this study is to compare early healing outcomes of implants placed by using osseocondensation and osseodensification techniques.
Both surgical techniques are currently used interchangeably. The outcomes of these procedures have not been compared within the same study. Thus, the investigators believe that a clinical study comparing these two protocols for early wound healing and bone remodeling would allow clinicians to make evidence-based choices in practice.
Working hypothesis is that there are no patient centered, clinical and radiographic differences between osseocondensation and osseodensification in early peri-implant wound healing outcomes and implant stability. Specific aims: 1. To determine wound closure and soft tissue healing following implant placement by using osseocondensation and osseodensification techniques. 2. To determine changes in CBCT bone density around implant placed with osseocondensation and osseodensification techniques. 3. To evaluate patient centered outcomes during surgery and early phases of wound healing following implant placement with osseocondensation and osseodensification.
Surgical technique being used in this study will be determined by the surgeon as part of standard care (patient and site-specific indications). *Research related procedures: - Radiographic and clinical measurements and recording of the alveolar ridge prior to surgery (dental radiographs and CBCT are routinely obtained as standard of care. The investigators will be using these documents to complete more in-depth analysis of the bone). - Clinical recording of the measurements for the alveolar ridge dimensions after flap elevation and after ridge expansion (this is routinely done as standard of care. The investigators will be recording it for research purpose). - Details of the surgery including bone quality (reported by surgeon), presence of buccal dehiscence/fenestration, the need of additional bone grafting of the ridge, the indications for barrier membrane placement. - Recording of implant stability by recording torque value and/or Osstell value (initial implant stability is an important parameter for the success of the implant and is routinely determined as standard care. The investigators will be recording it as part of the study). - Questions designed to evaluate patient experience (pain and discomfort during and after surgery).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osseodensification | Patients who are having the sinus lift procedure using the osseodensification technique |
| |
| Osseocondensation | Patients who are having the sinus lift procedure using the osseocondensation technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinus lift using osseodensification technique | Procedure | Osseodensification dislocates existing bone into trabeculated space by using a bur that turns in anti-clockwise direction. The procedure itself is not part of the research, but is the intervention of interest to the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ridge dimensions | Dimensions of the alveolar ridge, determined by measurements on the surgical stent and the CBCT images | Day of surgery and day of uncovery (4-6 months post-surgery) |
| Change in Bone Density | Bone density around the dental implant, measured via CBCT | Day of procedure and day of uncovery (4-6 months post-operative) |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Implant Stability | Implant stability by measurement of torque value and/or Osstell value, immediately following ridge augmentation and implant placement | Intraoperative |
| Final Implant Stability |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of the Graduate Periodontics Clinic at The Ohio State University College of Dentistry who have been treatment-planned for a dental implant and who require an indirect sinus lift procedure prior to implant placement.
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| Name | Affiliation | Role |
|---|---|---|
| Binnaz Leblebicioglu, DDS, MS, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Dentistry | Columbus | Ohio | 43210 | United States |
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| Sinus lift using the osseocondensation technique | Procedure | This procedure is performed by using osteotome hand instruments. The procedure itself is not part of the research, but is the intervention of interest to the study. |
|
Implant stability by measurement of torque value and/or Osstell value, at implant uncovery appointment 4-6 months post-surgery
| 4-6 months post-surgery |
| Healing Score Index 8-10 days PO | Pippi modification of Landry wound healing index):
| 8-10 days following the surgical procedure |
| Healing Score Index 6-8 weeks PO | Pippi modification of Landry wound healing index):
| 6-8 weeks following the surgical procedure |
| Wound Healing 8-10 days PO | Clinical wound healing will be scored as yes or no for each of the following wound healing parameters:
| 8-10 days following the surgical procedure |
| Wound Healing 6-8 weeks PO | Clinical wound healing will be scored as yes or no for each of the following wound healing parameters:
| 6-8 weeks following the surgical procedure |
| Patient Experience Day of Surgery | Patient centered evaluation immediately after surgery (if not sedated)
| surgical procedure |
| Patient Experience 8-10 Days PO | Patient centered outcomes:
Evaluated at first post-operative visit, 8-10 days following the surgical procedure | 8-10 days after surgery |
| Patient Experience 6-8 Weeks PO | Patient centered outcomes:
Evaluated at second post-operative visit | 6-8 weeks after surgery |
| Patient Experience 4-6 months PO | Patient centered outcomes:
Evaluated at implant uncovery appointment | 4-6 months after surgery |