Osseodensification Versus Conventional Drilling Effect on Implant Stability

NCT ID: NCT05824949

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2023-02-01

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.

Conditions

Implant Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Osseodensification (test) group

installation of 40 implants using the osseodensification protocol + measurement of implant stability (ISQ)

Group Type: EXPERIMENTAL

osseodensification drilling

Intervention Type: 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 (control) group

installation of 40 implants using the conventional drilling protocol + measurement of implant stability (ISQ)

Group Type: ACTIVE_COMPARATOR

conventional drilling

Intervention Type: 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.

Interventions

osseodensification drilling

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.

Intervention Type: PROCEDURE

conventional drilling

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arab American University (Palestine)

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Abu-Ta'a

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mahmoud Abu-Ta'a

Ramallah, , Palestinian Territories

Countries

Palestinian Territories

Other Identifiers

Implant stability

Identifier Type: -

Identifier Source: org_study_id