Evaluation of Implant Stability in Low Quality Bone Following the Use of Osseodensifiers Versus Ridge Expanders

Not Applicable

Completed

• Conditions: Low Bone Density
• Interventions: Procedure: Densah burs; Procedure: Ridge expansion screws

• Registration Number: NCT05330546
• Lead Sponsor: Cairo University

Brief Summary

the use of osseodensification technique compared to ridge expansion screws in low bone quality

Detailed Description

using Densah burs in preparation of implant osteotomy compared to ridge expansion screws in low quality bone

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-02
• Study First Submitted QC: 2022-04-10
• Study First Posted: 2022-04-15
• Status Verified: 2022-09
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Last Update Submitted: 2024-11-16
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• • Single tooth missing in the maxillary region with D3 (350-850 HU) and D4 (150-350 HU) bone (Sultana et al., 2020).

  • A minimum of 4 mm residual buccolingual bone width at site of implant placement (Koutouzis et al., 2019).

    • The recipient site of the implant should be free from any pathological conditions.
    • No diagnosed bone disease or medication known to affect bone metabolism.
    • Patients who are cooperative, motivated and hygiene conscious.
    • Patients having adequate inter-occlusal space of 8-10 mm (Fernández et al., 2017)

Exclusion Criteria

• Systemic conditions/diseases that contraindicate surgery (Jarikian et al., 2021).

  • Patients who have any habits that might jeopardize the osseointegration process, such as current smokers (Vollmer et al., 2020).
  • Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching (Sultana et al., 2020).
  • Alcohol or drug abuse (Ibrahim et al., 2020).
  • Pregnant and lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osseodensification technique group	Densah burs	10 patients will be randomly assigned to the osseodensification group so the implant osteotomy will be prepared using densah burs
Ridge expansion screw group	Ridge expansion screws	10 patients will be randomly assigned to the ridge expansion screw group so the implant osteotomy will be prepared using ridge expansion screws

Primary Outcome Measures

Name	Time	Method
Implant stability	change from baseline at 6 month	assessing the stability using Osstell

Secondary Outcome Measures

Name	Time	Method
Radiographic bone density	change from baseline at 6 month	using CBCT in mm
Change in crestal bone level	change from baseline at 6 month	using CBCT in mm
Change in buccolingual bone width	change from baseline at 6 month	using CBCT in mm
Patient reported outcomes	at time of surgery	10 mm Visual analogue scale from 1 to 10 with 1 minimal pain and 10 worst pain experience

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt