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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Implant Stability
• Intervention / Treatment: Other: Conventional drilling; Other: Densah Burs; Other: Osteotomes

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadine Yehia Mohamed, Bachelor's degree; Phone Number: 01019885817; Email: nadine.fayed@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Cairo University
    • Contact: Cairo University; Phone Number: 0223642705
    • Principal Investigator: Nadine Yehia Mohamed, Bachelor's degree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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.
Experimental: 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)	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 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's pain	Visual Analogue Scale (VAS) on a scale of 0 to 10 where (0) is no pain and (10) is the maximum pain.	Same day of surgery as well as 1 week postoperatively.
Patient satisfaction	Questionnaire (3 yes or no questions)	Same day f surgery as well as 1 and 2 weeks postoperatively.
Time spent in surgery	Minutes using stopwatch.	Same day of surgery (intraoperatively)
Patient's pain	Number of analgesic tablets.	Same day of surgery as well as 1 week postoperatively.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Crestal bone loss; Osseodensification; Implant stability; Osteotomes; Dental implant placement
• Other Study ID Numbers: PERIO631- Perio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No