Osseodensification Versus Conventional Drilling Effect on Implant Stability

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

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.

Study Overview

• Status: Completed
• Conditions: Implant Therapy
• Intervention / Treatment: Procedure: osseodensification drilling; Procedure: conventional drilling

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • Ramallah, Palestinian Territory, occupied
    • Mahmoud Abu-Ta'a

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osseodensification (test) group; installation of 40 implants using the osseodensification protocol + measurement of implant stability (ISQ)	Procedure: 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.
Active Comparator: Conventional (control) group; installation of 40 implants using the conventional drilling protocol + measurement of implant stability (ISQ)	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arab American University (Palestine)

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Implant stability

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No