Clinical trial NCT06871657: Comparing Two Surgical Techniques for Building Up the Bone Where a Dental Implant is to Be Placed
Official title: Alveolar Ridge Expansion During Indirect Sinus Lift Procedures--A Comparison of Two Surgical Techiques
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dental Implant
Sinus Floor Augmentation
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 18-75 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in ridge dimensions
timeFrame: Day of surgery and day of uncovery (4-6 months post-surgery)
measure: Change in Bone Density
timeFrame: Day of procedure and day of uncovery (4-6 months post-operative)
Secondary outcomes:
measure: Initial Implant Stability
timeFrame: Intraoperative
measure: Final Implant Stability
timeFrame: 4-6 months post-surgery
measure: Healing Score Index 8-10 days PO
timeFrame: 8-10 days following the surgical procedure
measure: Healing Score Index 6-8 weeks PO
timeFrame: 6-8 weeks following the surgical procedure
measure: Wound Healing 8-10 days PO
timeFrame: 8-10 days following the surgical procedure
measure: Wound Healing 6-8 weeks PO
timeFrame: 6-8 weeks following the surgical procedure
measure: Patient Experience Day of Surgery
timeFrame: surgical procedure
measure: Patient Experience 8-10 Days PO
timeFrame: 8-10 days after surgery
measure: Patient Experience 6-8 Weeks PO
timeFrame: 6-8 weeks after surgery
measure: Patient Experience 4-6 months PO
timeFrame: 4-6 months after surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Dentistry
state: Ohio
Study officials:
affiliation: Ohio State University
name: Binnaz Leblebicioglu, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: