Clinical and Radiographic Evaluation of Implant Stability in Healed Maxillary Posterior Sites Comparing Osteotome, Osseodensification and Conventional Drilling Implant Placement Techniques

Not Applicable

Recruiting

• Conditions: Implant Stability
• Interventions: Other: Conventional drilling; Other: Densah Burs; Other: Osteotomes

• Registration Number: NCT06599112
• Lead Sponsor: Cairo University

Brief Summary

This study aims to compare the implant stability values following implant placement via Osteotomes and via Osseodensification using Densah Burs versus implant placement using conventional drilling technique in patients with upper posterior partially edentulous ridges as well as evaluating the crestal bone loss around temporary restorations following the three compared drilling techniques.

Detailed Description

* Patients with partially edentulous ridges seeking restoration of their missing teeth, with enough measurements for implant placement will be recruited from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University to participate in this study and will be randomized to be either undergoing conventional drilling according to the manufacturer's instructions (control group) or either one of the two intervention groups; Intervention group (A) where implant placement will be done using the Osseodensification technique by the Densah burs or Intervention group (B) where the implant placement will be done using the Osteotomes.

* Neobiotech IS III active implants will be used in this study, they have an osseoconductive SLA-coated surface, a tapered design with a crestal macrothread design (0.8 pitch), a self compactable apex as well as deep thread to maximize implant stability. The implant has a platform switching feature and a conical/hex design.

* A temporary PMMA crown after 3 months from implant placement and will be kept for follow up for a year then definitive final restoration will be made.

Study Timeline

• Study First Submitted: 2024-08-16
• Status Verified: 2024-09
• Study Start: 2024-09
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients with an age range of 25-70 years

• Patients with systemic health

• Patient with missing teeth in the upper posterior area

• Patients with D3 or D4 type of alveolar bone

• Healed bony sites with sufficient dimension for implant placement

  • Vertical height (≥ 10 mm)
  • Bucco-lingual dimension (≥ 5.5 mm)
  • Mesio-distal width (≥6.5 mm)

• Patients with periodontal health (PD < 4mm, BOP < 10%)

• Inter-arch space of 7.5 to allow implant restoration

• Good oral hygiene

• Cooperative patients who accepted the trial follow up period and sign the informed consent

Exclusion Criteria

• Pregnant females
• Smokers
• Patients with habits that may compromise the longevity and affect the result of the implant as alcoholism or parafunctional habits
• History of radiotherapy or use of bisphosphonates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional drilling for implant placement	Conventional drilling	Implant placement in this group will be by conventional drilling according to the manufacturer's instructions (consequent drills according to the kit provided)
Implant placement using Densah Burs	Densah Burs	Densah Burs provided by Versah will be used as the Osseodensification drilling technique for implant placement in this group. (consequent drilling according to the kit provided)
Implant placement using Osteotomes	Osteotomes	Osteotomes with different serial diameters will be used following the pilot drill to expand and condense the osteotomy site as a technique for implant placement.

Primary Outcome Measures

Name	Time	Method
Implant stability.	Will take place at same day,1,2,3,4,6,8 ,12and 16 weeks postoperatively.	ISQ units. (Implant Stability Quotient)

Secondary Outcome Measures

Name	Time	Method
Crestal bone loss	Will be evaluated to determine the initial crestal bone level at day of the surgery as well at 12 and 48 weeks postoperatively.	Millimeters in standardized periapical radiograph

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt