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

NCT06599112 | Recruiting DMC

• 1 other identifier: PERIO631- Perio
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant Stability

Keywords

Dental implant placement; Osseodensification; Osteotomes; Implant stability; Crestal bone loss

Outcome Measures

Primary Outcomes (1)

• Implant stability.

  ISQ units. (Implant Stability Quotient)

  Will take place at same day,1,2,3,4,6,8 ,12and 16 weeks postoperatively.

Secondary Outcomes (1)

• 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.

Other Outcomes (4)

• Patient's pain

  Same day of surgery as well as 1 week postoperatively.

• Patient satisfaction

  Same day f surgery as well as 1 and 2 weeks postoperatively.

• Time spent in surgery

  Same day of surgery (intraoperatively)

Study Arms (3)

Conventional drilling for implant placement

ACTIVE COMPARATOR

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

Other: Conventional drilling

Implant placement using Densah Burs

EXPERIMENTAL

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)

Other: Densah Burs

Implant placement using Osteotomes

EXPERIMENTAL

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.

Other: Osteotomes

Interventions

Densah Burs 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 Densah Burs

Osteotomes 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.

Implant placement using Osteotomes

Conventional drilling 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.

Conventional drilling for implant placement

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

Central Study Contacts

Nadine Yehia Mohamed, Bachelor's degree

CONTACT

01019885817; nadine.fayed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: * Participants and investigator couldn't be blinded. * Outcome assessor and biostatistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three groups. Control Group Intervention group (A) Intervention group (B)

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)