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

Official title

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

Overview

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.

Interventions

• Other Densah Burs
  Series of drilling burs inserted in the osteotomy with special design that have a large negative rake angle flute, a cutting chisel edge and a tapered shank, so as they enter deeper into the osteotomy and they have a progressively increasing diameter that controls the expansion process. These burs are used with a standard surgical engine and can densify bone by rotating in the noncutting direction (counterclockwise at 800-1,200 rotations per minute) or drill bone by rotating in the cutting direc
• Other Osteotomes
  The osteotomes kit are a series of tools that first designed by Summers in 1994. The concept was to maintain the existing bone by compressing trabecular bone laterally and apically with minimal trauma to improve the bone density. The condensed bone in this way will have to put in act a double repairing mechanism, from one side represented by the normal processes of osteointegration and on the other side from the processes of the reparation post fracture like that depends on BMU (bone modelling u
• Other Conventional drilling
  The implant drilling kit provided by the manufacturer will be used for the implant placement, using the pilot drill followed by consequent drills according to the size of the osteotomy needed.

Primary outcome measures

• Implant stability. [Time frame: Will take place at same day,1,2,3,4,6,8 ,12and 16 weeks postoperatively.]

Secondary outcome measures (1)

• Crestal bone loss [Time frame: Will be evaluated to determine the initial crestal bone level at day of the surgery as well at 12 and 48 weeks postoperatively.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Cairo University — Giza

Identifiers

NCT: NCT06599112 · PERIO631- Perio

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗