Osseodensification Versus Conventional Drilling Effect on Implant Stability

NCT05824949 | Completed

• 1 other identifier: Implant stability
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Torque value (N/cm)

  directly after implant insertion

Study Arms (2)

Osseodensification (test) group

EXPERIMENTAL

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

Procedure: osseodensification drilling

Conventional (control) group

ACTIVE COMPARATOR

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

Procedure: conventional drilling

Interventions

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.

Osseodensification (test) group

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.

Conventional (control) group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arab American University (Palestine): lead

Study Sites (1)

Mahmoud Abu-Ta'a

Ramallah, Palestinian Territories

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 24, 2023
• Study Start: April 4, 2022
• Primary Completion: June 1, 2022
• Study Completion: February 1, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

PA (1)