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

NCT ID: NCT06599112

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-12-31

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.

Conditions

Implant Stability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional drilling for implant placement

Implant placement in this group will be by conventional drilling according to the manufacturer's instructions (consequent drills according to the kit provided)

Group Type: ACTIVE_COMPARATOR

Conventional drilling

Intervention Type: OTHER

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.

Implant placement using 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)

Group Type: EXPERIMENTAL

Densah Burs

Intervention Type: OTHER

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 direction (clockwise at 800-1,200 rotations per minute) with an in and out movement together with copious saline irrigation and increasing bone plasticity and ability to expand under rate dependent stress.

Implant placement using 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.

Group Type: EXPERIMENTAL

Osteotomes

Intervention Type: OTHER

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 units) which create new spaces for the new vessels and afterwards filling all the gaps between the bone and the implant.

Interventions

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 direction (clockwise at 800-1,200 rotations per minute) with an in and out movement together with copious saline irrigation and increasing bone plasticity and ability to expand under rate dependent stress.

Intervention Type: 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 units) which create new spaces for the new vessels and afterwards filling all the gaps between the bone and the implant.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nadine Yehia Mohamed Mohamed Fayed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nadine Yehia Mohamed, Bachelor's degree

Role: CONTACT

nadine.fayed@dentistry.cu.edu.eg

01019885817

Facility Contacts

Cairo University

Role: primary

0223642705

Other Identifiers

PERIO631- Perio

Identifier Type: -

Identifier Source: org_study_id