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Clinical Trials/NCT05824949
NCT05824949
Completed
N/A

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

Arab American University (Palestine)1 site in 1 country40 target enrollmentApril 4, 2022
ConditionsImplant Therapy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Implant Therapy
Sponsor
Arab American University (Palestine)
Enrollment
40
Locations
1
Primary Endpoint
Mechanical or primary stability
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 4, 2022
End Date
February 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Arab American University (Palestine)
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Abu-Ta'a

Associate Professor

Arab American University (Palestine)

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Mechanical or primary stability

Time Frame: directly after implant placement

ISQ values at implant installation

Biological or secondary stability

Time Frame: 4 months after implant installation

ISQ values at abutment connection

Secondary Outcomes

  • Torque value (N/cm)(directly after implant insertion)

Study Sites (1)

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