The Effect of Osseodensification on Implant Stability in Posterior Maxilla

NCT04442763 | Completed FDA Device

• 1 other identifier: Sara89
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Implants will be placed in posterior maxilla using two drilling methods; the osseodensification technique and conventional drilling protocols. Implant stability will be measured after implant placement , 1,2,3,4,6 and 8 weeks and 3 months later. Insertion torque will be evaluated at the termination of implant placement and crestal bone loss will be measured post-implant insertion, after 3 months and after 6 and 12 months of loading. Post-operative pain and patients' satisfaction will be assessed as well. implant survival will be assessed at the end of the follow up period

Conditions

Implant Stability

Keywords

Osseodensification; Densah burs; conventional drilling; implant stability

Outcome Measures

Primary Outcomes (1)

• Implant stability

  Implant stability will be measured using Osstell (Resonance Frequency Analysis). the measurement unit is Implant stability quotient (ISQ) (range 1-100)

  immediately post-implant insertion, 1,2,3,4,6,8 weeks and 3 months

Secondary Outcomes (2)

• Crestal bone loss

  immediately post-implant insertion - 3 months- 6 and 12 months post-loading

• Insertion torque

  at the termination of implant insertion

Study Arms (2)

Densah burs

EXPERIMENTAL

Osseodensification using Densah burs

Device: Densah Burs

Standard drills

ACTIVE COMPARATOR

conventional drilling using standard drills

Device: Standard drills

Interventions

Densah Burs DEVICE

osseodensification method

Densah burs

Standard drills DEVICE

conventional drilling

Standard drills

Eligibility Criteria

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

You may qualify if:

• Age: \>18 years; medically free,
• Partially edentulous patients in maxillary posterior area (premolar-molar area)
• Sufficient ridge height
• Sufficient ridge width
• Adequate soft tissue biotype.
• Patients with adequate inter-arch space for placement of implant prosthetic part.
• Cooperative patients with good oral hygiene
• Patients who accept to sign an informed consent.

You may not qualify if:

• Active periodontal diseases
• Parafunctional habits.
• History of radiation therapy to the head and neck
• Bone augmentation to implant site
• Smoking
• Pregnant females

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

• Abdelraouf SA, Dahab OA, Mostafa B, Kenawy SM, Tawfik OK. Implant stability in the posterior maxilla: clinical and radiographic comparison of osseodensification and conventional drilling: a randomized clinical trial. Clin Oral Investig. 2025 Sep 29;29(10):480. doi: 10.1007/s00784-025-06526-8.

  PMID: 41016918 DERIVED

Study Officials

• Omnia Aboul Dahab

  Professor, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the statistician will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 23, 2020
• Study Start: January 3, 2021
• Primary Completion: December 10, 2022
• Study Completion: December 20, 2023
• Last Updated: January 3, 2025

Record last verified: 2024-12

Locations

EG (1)