Septal Bone Expansion Using Osseodensification Versus Piezoelectric Implant Site Preparation

NCT06957860 | Completed

• 1 other identifier: 0716-06/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

: Implant placement in the inter radicular septum is usually considered the best option for an immediate molar implant, not only in terms of correct 3D positioning, but also regarding implant survival, Osseodensification was shown to enhance implant primary stability, due to the compaction auto-grafting and the associated spring-back effect. Piezoelectric implant site preparation (PISP) has been proposed as an alternative technique to improve surgical control, safety, and bone healing response Aim of the work: To evaluate and compare stability changes using insertion torque values (ITV) and Implant Stability Quotient values (ISQ) for immediately placed implants in molar septum using Osseodensification technique and Piezoelectric implant site preparation (PISP) technique.

Conditions

Dental Implant; Osseodensification

Outcome Measures

Primary Outcomes (1)

• Change in implant stability

  The implant stability quotient (ISQ) will be measured using the Osstell device- resonance frequency analysis test at 3 months post-surgery to all the installed fixtures.

  Baseline and 3 months

Secondary Outcomes (1)

• Change in bone density

  Baseline and 3 months

Study Arms (2)

piezoelectric group

EXPERIMENTAL

Other: Piezotome

osseodensification

EXPERIMENTAL

Other: Densah burs

Interventions

Piezotome OTHER

Four Intra-lift diamond tips were used for drilling the osteotomy, increasing diameters till a final diameter of 2.8 mm is reached for placement of 3.5 mm diameter and 10-12 mm length implant.

piezoelectric group

Densah burs OTHER

implant drilling procedures will be done using the surgical drills of the supplier kit of densah burs. Surgical drills of increasing diameters will be used till a final drill diameter of 3 mm for placement of a 3.5 mm diameter.

osseodensification

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients with hopeless mandibular molar teeth in the posterior region in need of implant placement .
• A fully intact facial bone wall at the extraction site.
• Systemically healthy, received no head and neck radiation for cancer treatment.
• Absence of periapical pathologies or suppuration at the time of installing the implants.
• Septal bone after atraumatic extraction not less than 3 mm.

You may not qualify if:

• Systemic conditions that would prevent successful healing or implant osseointegration; examples are uncontrolled Diabetes Mellitus, metabolic bone disorders, autoimmune diseases, or Bisphosphonate therapy.
• Heavy smoker patients.
• Presence of preapical bone loss related to extracted tooth.
• Patient is not indicated for immediate implant placement

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the statistician will be blinded to the treatment groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 5, 2025
• Study Start: November 23, 2023
• Primary Completion: August 24, 2024
• Study Completion: August 24, 2024
• Last Updated: May 5, 2025

Record last verified: 2025-04

Locations

EG (1)