Osseodensification Versus Conventional Drilling Effect on Implant Stability

• Sponsor: Arab American University (Palestine) (Other)
• Overall Status: Completed
• CT.gov ID: NCT05824949
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Implant Therapy	Procedure: osseodensification drilling; Procedure: conventional drilling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Impact of Osseodensification and Conventional Drilling Protocols on Implants Mechanical and Biological Stability in Posterior Maxilla: A Randomized Controlled Clinical Trial
• Actual Study Start Date: Apr 4, 2022
• Actual Primary Completion Date: Jun 1, 2022
• Actual Study Completion Date: Feb 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Mechanical or primary stability [directly after implant placement]

   ISQ values at implant installation

2. Biological or secondary stability [4 months after implant installation]

   ISQ values at abutment connection

Secondary Outcome Measures

1. Torque value (N/cm) [directly after implant insertion]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mahmoud Abu-Ta'a	Ramallah		Palestinian Territory, occupied

Sponsors and Collaborators

• Arab American University (Palestine)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahmoud Abu-Ta'a, Associate Professor, Arab American University (Palestine)
• ClinicalTrials.gov Identifier: NCT05824949
• Other Study ID Numbers: Implant stability
• First Posted: Apr 24, 2023
• Last Update Posted: Apr 24, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 24, 2023