Dental ImplantNCT06871657
Comparing Two Surgical Techniques for Building up the Bone Where a Dental Implant is to be Placed
An observational study of Dental Implant and Sinus Floor Augmentation, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dental Implant, Sinus Floor Augmentation
- What is being tested?
- Sinus lift using osseodensification technique and Sinus lift using the osseocondensation technique
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Dentistry
Columbus, Ohio, 43210
About this study
Official title: Alveolar Ridge Expansion During Indirect Sinus Lift Procedures--A Comparison of Two Surgical Techiques
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.
Read more
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.
Read the 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).
- Conditions
- Dental Implant, Sinus Floor Augmentation
- Being tested
- Sinus lift using osseodensification technique, Sinus lift using the osseocondensation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus lift using osseodensification techniqueProcedure or surgery
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.
Sinus lift using the osseocondensation techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Osseodensification | Patients who are having the sinus lift procedure using the osseodensification technique Receives: Procedure: Sinus lift using osseodensification technique | |
| Osseocondensation | Patients who are having the sinus lift procedure using the osseocondensation technique Receives: Procedure: Sinus lift using the osseocondensation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ridge dimensions
Dimensions of the alveolar ridge, determined by measurements on the surgical stent and the CBCT images
Measured: 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
Measured: Day of procedure and day of uncovery (4-6 months post-operative)
Secondary outcomes (10)
Initial Implant Stability
Implant stability by measurement of torque value and/or Osstell value, immediately following ridge augmentation and implant placement
Measured: Intraoperative
Final Implant Stability
Implant stability by measurement of torque value and/or Osstell value, at implant uncovery appointment 4-6 months post-surgery
Measured: 4-6 months post-surgery
Healing Score Index 8-10 days PO
Pippi modification of Landry wound healing index):
- presence/absence of redness;
- presence/absence of granulation tissue;
- presence/absence of suppuration;
- presence/absence of swelling;
- degree of tissue epithelialization (partial/complete);
- presence/absence of bleeding;
- presence/absence of pain on palpation.
- presence/absence of plaque (% of plaque positive surfaces) Performed at first follow-up appointment, 8-10 days post surgery
Measured: 8-10 days following the surgical procedure
Healing Score Index 6-8 weeks PO
Pippi modification of Landry wound healing index):
- presence/absence of redness;
- presence/absence of granulation tissue;
- presence/absence of suppuration;
- presence/absence of swelling;
- degree of tissue epithelialization (partial/complete);
- presence/absence of bleeding;
- presence/absence of pain on palpation.
- presence/absence of plaque (% of plaque positive surfaces) Performed at second follow-up appointment, 6-8 weeks days post surgery
Measured: 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:
- Mature wound healing, defined as complete wound closure without other significant findings.
- Erythema, defined as increased redness compared to adjacent non-operated sites
- Bleeding, defined as presence of spontaneous bleeding at the wound site
- Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe {if grafting was done during surgery}
- Suppuration, defined as presence of pus or discharge at the wound site
- Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site
- Clinical wound exposure( ____ mm)and closure and hydrogen peroxide test(+/-) Assessment performed 8-10 days after surgery
Measured: 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:
- Mature wound healing, defined as complete wound closure without other significant findings.
- Erythema, defined as increased redness compared to adjacent non-operated sites
- Bleeding, defined as presence of spontaneous bleeding at the wound site
- Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe {if grafting was done during surgery}
- Suppuration, defined as presence of pus or discharge at the wound site
- Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site
- Clinical wound exposure( ____ mm)and closure and hydrogen peroxide test(+/-) Assessment performed 6-8 weeks after surgery
Measured: 6-8 weeks following the surgical procedure
Patient Experience Day of Surgery
Patient centered evaluation immediately after surgery (if not sedated)
- Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)
- Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- Any other reported issues
Measured: surgical procedure
Patient Experience 8-10 Days PO
Patient centered outcomes:
- Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)
- Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days)
- Any reported issues
Evaluated at first post-operative visit, 8-10 days following the surgical procedure
Measured: 8-10 days after surgery
Patient Experience 6-8 Weeks PO
Patient centered outcomes:
- Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)
- Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days)
- Any reported issues
Evaluated at second post-operative visit
Measured: 6-8 weeks after surgery
Patient Experience 4-6 months PO
Patient centered outcomes:
- Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)
- Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days)
- Any reported issues
Evaluated at implant uncovery appointment
Measured: 4-6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start3 May 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binnaz Leblebicioglu, Ohio State University
- Investigators
- Binnaz Leblebicioglu, DDS, MS, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871657
- Sponsor's protocol ID
- 2023H0106
- Status last verified
- Feb 2026
- First submitted
- 6 Mar 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Expansion During Indirect Sinus Lift Procedures--A Comparison of Two Surgical Techiques
- ClinicalTrials.gov ID
- NCT06871657
- Acronym / sponsor ID
- 2023H0106
- Conditions
- Dental Implant, Sinus Floor Augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osseodensification | – | Procedure: Sinus lift using osseodensification techniquePatients who are having the sinus lift procedure using the osseodensification technique |
| Osseocondensation | – | Procedure: Sinus lift using the osseocondensation techniquePatients who are having the sinus lift procedure using the osseocondensation technique |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 18-75 years old
- Systemically healthy
- No contraindications for implant placement surgery
- No chronic sinus problems
- Non-smoker
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinus lift using osseodensification techniqueOsseodensification 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. | Procedure or surgery | Osseodensification |
| Sinus lift using the osseocondensation techniqueThis 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. | Procedure or surgery | Osseocondensation |
Primary outcome
Change in ridge dimensions
Time frame: Day of surgery and day of uncovery (4-6 months post-surgery)
Dimensions of the alveolar ridge, determined by measurements on the surgical stent and the CBCT images
Change in Bone Density
Time frame: Day of procedure and day of uncovery (4-6 months post-operative)
Bone density around the dental implant, measured via CBCT
10 secondary outcomes
Initial Implant Stability
Time frame: Intraoperative
Final Implant Stability
Time frame: 4-6 months post-surgery
Healing Score Index 8-10 days PO
Time frame: 8-10 days following the surgical procedure
Healing Score Index 6-8 weeks PO
Time frame: 6-8 weeks following the surgical procedure
Wound Healing 8-10 days PO
Time frame: 8-10 days following the surgical procedure
Wound Healing 6-8 weeks PO
Time frame: 6-8 weeks following the surgical procedure
Patient Experience Day of Surgery
Time frame: surgical procedure
Patient Experience 8-10 Days PO
Time frame: 8-10 days after surgery
Patient Experience 6-8 Weeks PO
Time frame: 6-8 weeks after surgery
Patient Experience 4-6 months PO
Time frame: 4-6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binnaz Leblebicioglu, DDS, MS, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant and Sinus Floor Augmentation, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ridge dimensions (time frame: Day of surgery and day of uncovery (4-6 months post-surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.