Osseodensification Versus Conventional Drilling Effect on Implant Stability

Study Overview
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Brief Summary
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A total of 80 implants were placed in the posterior region of the maxilla in 40 patients in a split-mouth design. Bone quality was classified into type I, II, III, IV, or V as assessed preoperatively on cone-beam computed tomography (CBCT) . Primary implant stability was measured with insertion torque and resonance frequency analysis (ISQ values). Secondary stability was measured by ISQ at abutment installation.

Official Title
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The Impact of Osseodensification and Conventional Drilling Protocols on Implants Mechanical and Biological Stability in Posterior Maxilla: A Randomized Controlled Clinical Trial

Conditions
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Implant Therapy

Intervention / Treatment
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* Procedure: osseodensification drilling
* Procedure: conventional drilling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (a) Bilateral edentulism in the maxillary posterior region dating back more than 6 months, (b) sufficient bone height (distance between the bone crest and maxillary sinus >8 mm) and width at the alveolar crest (≥6 mm) that would not necessitate bone augmentation, (c) at least 2 mm vestibular keratinized mucosa width and 3 mm mucosa thickness, (d) full-mouth plaque and bleeding scores <20%. Exclusion Criteria: patients with systemic diseases, conditions, or used medications having the potential to impair surgery, bone, and wound healing dynamics (such as diabetes) will be excluded. patients who are allergic to antibiotics and non-steroidal anti-inflammatory drugs bone height <8mm ridge and soft tissue deficiencies requiring augmentation procedures and endodontic or periodontal lesions neighboring the edentulous sites will be also excluded.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osseodensification (test) group<br>installation of 40 implants using the osseodensification protocol + measurement of implant stability (ISQ) | Procedure: osseodensification drilling<br>* Implant mechanical and biological stability measured using ISQ values at the time of implant placement and at abutment connection for 40 implants placed in the posterior maxillary area using the osseodensification protocol.<br>|
| Active Comparator: Conventional (control) group<br>installation of 40 implants using the conventional drilling protocol + measurement of implant stability (ISQ) | Procedure: conventional drilling<br>* Implant mechanical and biological stability measured using ISQ values at the time of implant placement and at abutment connection for 40 implants placed in the posterior maxillary area using the conventional drilling protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical or primary stability | ISQ values at implant installation | directly after implant placement | 
| Biological or secondary stability | ISQ values at abutment connection | 4 months after implant installation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Torque value (N/cm) | Torque value shown at the physiodispenser screen at the end of implant installation | directly after implant insertion |