Comparing Two Surgical Techniques for Building up the Bone Where a Dental Implant is to be Placed

NCT06871657 | Completed

• 1 other identifier: 2023H0106
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Is there a difference in wound closure and soft tissue healing following implant placement using osseocondensation versus osseodensification?
• Is there a difference in bone density around implants placed with osseocondensation versus osseodensification?
• Is there a difference in patient experience during surgery and early phases of healing with osseocondensation versus osseodensification? Researchers will compare implant sites where the osseocondensation technique was used to sites where the osseodensification technique was used to see if there are differences in the outcomes. 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.

Conditions

Sinus Floor Augmentation; Dental Implant

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (10)

• Initial Implant Stability

  Intraoperative

• Final Implant Stability

  4-6 months post-surgery

• Healing Score Index 8-10 days PO

  8-10 days following the surgical procedure

• Healing Score Index 6-8 weeks PO

  6-8 weeks following the surgical procedure

• Wound Healing 8-10 days PO

  8-10 days following the surgical procedure

Study Arms (2)

Osseodensification

Patients who are having the sinus lift procedure using the osseodensification technique

Procedure: Sinus lift using osseodensification technique

Osseocondensation

Patients who are having the sinus lift procedure using the osseocondensation technique

Procedure: Sinus lift using the osseocondensation technique

Interventions

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.

Osseocondensation

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.

Osseodensification

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• years old
• Systemically healthy
• No contraindications for implant placement surgery
• No chronic sinus problems
• Non-smoker
• Minimum ridge width of 3 mm and ridge height of 5 mm

You may not qualify if:

• need for ENT specialist clearance due to active problems in relation to ear, not, throat related chronic problems
• sufficient bone volume to perform implant placement without ridge augmentation
• Require guided bone regeneration prior to implant placement
• Need to wear a removable temporary restoration during healing

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Dentistry

Columbus, Ohio, 43210, United States

Location

Study Officials

• Binnaz Leblebicioglu, DDS, MS, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: May 3, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)