- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07244185
Comparison of Osseodensification and Conventional Drilling on the Stability of Tapered and Cylindrical Implants.
The Effect of Osseodensification and Conventional Implant Site Preparation on Implant Stability of Tapered and Cylindrical Dental Implants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dental implant stability is a key factor influencing the success of osseointegration and the long-term prognosis of implant-supported restorations. The stability of an implant can be divided into two phases: primary stability, which depends on the mechanical engagement between the implant and the surrounding bone at the time of placement, and secondary stability, which develops through biological bone remodeling and osseointegration over time.
Traditional (conventional) drilling techniques used for implant site preparation are subtractive in nature, meaning they remove bone to create space for the implant. However, this process may reduce bone density at the osteotomy walls, particularly in low-density bone, potentially compromising initial stability.
Osseodensification (OD) is a relatively new, non-subtractive drilling technique introduced by Huwais and colleagues. Instead of removing bone, OD uses specially designed, counterclockwise rotating burs (Densah burs) that laterally compact and densify bone along the walls of the osteotomy.
mplant macrodesign-particularly whether the implant is tapered or cylindrical-also influences stability outcomes.
Tapered implants typically provide higher primary stability due to their wedging effect and better adaptation in underprepared osteotomies, especially in soft bone.
Cylindrical implants, while providing more uniform stress distribution, may rely more heavily on bone density and precise site preparation for achieving optimal stability.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Baghdad Governorate
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Baghdad, Baghdad Governorate, Iraq, 10001
- university of baghdad college of dentistry Teaching hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1-Patients who are willing to comply with the study and give their consent. 2-Ability to tolerate conventional surgical and restorative procedure. 3- Healthy patients over 18 years of either gender, having single or multiple missing teeth in the maxilla and/or mandible
Exclusion Criteria:
- Active infection or inflammation in implant area or neighboring zone.
- Systemic conditions (medically compromised patient) such as uncontrolled diabetes, coagulation disorders, immune compromised patient, patient treated with bisphosphate drugs, psychiatric problems or unrealistic expectations, pregnant women, any medical condition that affect bone healing.
- Clinical evidence of parafunctional habits.
- Active periodontitis.
- Heavy smokers (≥20 cigarettes a day).
- Advanced and complicated cases.
- Patients who not able to follow the treatment protocol or lost during the study period.
- Patient with history of radiotherapy to the head and neck -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: tapered implant with conventional preparation
The osteotomy will be performed following the manufacturer's standard drilling sequence without osseodensification. This group will serve to evaluate the effect of conventional implant site preparation on the primary and secondary stability of tapered implants |
Placement of tapered or cylindrical dental implants using osseodensification (bone-compacting technique) or conventional drilling to evaluate implant stability.
|
|
Experimental: tapered with osseodensification
The osteotomy will be prepared with densifying burs operated in a non-subtractive, counterclockwise direction to compact and preserve bone tissue. This approach aims to enhance bone density and improve the primary and secondary stability of the tapered implants |
Placement of tapered or cylindrical dental implants using osseodensification (bone-compacting technique) or conventional drilling to evaluate implant stability.
|
|
Experimental: cylindrical implant with conventional preparation
The osteotomy will be performed following the standard sequential drilling protocol recommended by the manufacturer, without applying osseodensification. This group will be used to assess the effect of conventional implant site preparation on the primary and secondary stability of cylindrical implants |
Placement of tapered or cylindrical dental implants using osseodensification (bone-compacting technique) or conventional drilling to evaluate implant stability.
|
|
Experimental: cylindrical with osseodensification
The osteotomy will be performed using densifying burs in a non-subtractive, counterclockwise direction, which compacts and preserves the surrounding bone tissue. This method is intended to increase bone density and improve both primary and secondary implant stability for cylindrical implants |
Placement of tapered or cylindrical dental implants using osseodensification (bone-compacting technique) or conventional drilling to evaluate implant stability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
primary stability
Time Frame: at the time of surgery
|
Primary stability refers to the mechanical stability of a dental implant (or any bone implant) immediately after placement, before bone healing or osseointegration occurs. It mainly depends on bone quality and density, implant design, and surgical technique.it measured using the osstell through Resonance Frequency Analysis,Higher ISQ values indicate greater primary stability.more than 70 ISQ is considerd high stability. Achieving good primary stability is crucial for implant success, as it helps prevent micromovements and supports proper secondary (biological) stability during healing, |
at the time of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
secondary stability
Time Frame: after 12 weeks
|
Secondary stability refers to the biological stability of a dental implant that develops over time through osseointegration, the direct structural and functional connection between the implant surface and surrounding bone. Unlike primary stability, which is mechanical, secondary stability results from bone healing, remodeling, and new bone formation around the implant ..it measured using the osstell through Resonance Frequency Analysis,Higher ISQ values indicate greater stability.more than 70 ISQ is considerd high stability. |
after 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 974124-2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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