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OpenTrials
Completed

NCT Number: NCT05824949

Osseodensification Versus Conventional Drilling Effect on Implant Stability

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.

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Key information

Conditions

Implant Therapy

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahmoud Abu-Ta'a

Ramallah, Palestinian Territories

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

osseodensification drilling

Procedure

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.

Conventional drilling

Procedure

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.

Primary outcomes

  1. Mechanical or primary stability

    Time frame: directly after implant placement

    ISQ values at implant installation

  2. Biological or secondary stability

    Time frame: 4 months after implant installation

    ISQ values at abutment connection

Secondary outcomes

  1. Torque value (N/cm)

    Time frame: directly after implant insertion

    Torque value shown at the physiodispenser screen at the end of implant installation

Sponsors and collaborators

Lead sponsor

Arab American University (Palestine)

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 24, 2023
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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