Osseodensification Versus Conventional Drilling Effect on Implant Stability

Not Applicable

Completed

• Conditions: Implant Therapy
• Interventions: Procedure: conventional drilling; Procedure: osseodensification drilling

• Registration Number: NCT05824949
• Lead Sponsor: Arab American University (Palestine)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-04
• Primary Completion: 2022-06-01
• Study Completion: 2023-02-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional (control) group	conventional drilling	installation of 40 implants using the conventional drilling protocol + measurement of implant stability (ISQ)
Osseodensification (test) group	osseodensification drilling	installation of 40 implants using the osseodensification protocol + measurement of implant stability (ISQ)

Primary Outcome Measures

Name	Time	Method
Mechanical or primary stability	directly after implant placement	ISQ values at implant installation
Biological or secondary stability	4 months after implant installation	ISQ values at abutment connection

Secondary Outcome Measures

Name	Time	Method
Torque value (N/cm)	directly after implant insertion	Torque value shown at the physiodispenser screen at the end of implant installation

Trial Locations

Locations (1)

Mahmoud Abu-Ta'a; 🇵🇸 Ramallah, Palestinian Territory, occupied