Implants Placed With Crestal Sinus Approach Versus Osseodensification in Atrophic Posterior Maxilla

NCT06207578 | Not Yet Recruiting

• 1 other identifier: IDCE.N7
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

However, recently, most described techniques for posterior atrophic maxillary rehabilitation, are targeting more conservative, cost-effective and efficient methods for sinus elevation eliminating its lateral access. The aim of the present study is to evaluate and compare the long-term implant stability for implants placed by the novel crestal sinus approach versus osseodensification using Densa-bur in Atrophic Posterior Maxilla.

Conditions

Implants

Keywords

osseodensification; densah bur; Crestal implant approach; closed sinus elevation

Outcome Measures

Primary Outcomes (1)

• Long- term Implant Stability

  Resonance frequency analysis will be employed with a dedicated device (Osstell). For each implant, implant stability quotient ISQ values will measured from the four sites (mesial, distal, buccal, and palatal sites). The mean of all measurements will be rounded to a whole number and regarded as the final ISQ of the implant. ISQ values will obtained after implant placement (T1), after loading (T2), 6 months after loading (T3) follow up intervals.

  12 months

Secondary Outcomes (3)

• Implant survivability

  12 months

• Vertical bone height formed

  12 months

• Post operative pain

  10 days

Study Arms (2)

Implant placement using crestal sinus approach

EXPERIMENTAL

Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place and the implant itself will be used to gently elevate the sinus up to 3-5mm.

Procedure: implant placement using crestal sinus approach

Implant placement using osseodensification

ACTIVE COMPARATOR

Using Densah bur kit foe osteotomy preparation followed by implant placement

Procedure: Implant placement using osseodensification

Interventions

implant placement using crestal sinus approach PROCEDURE

a Full thickness flap will be elevated at the edentulous site with two vertical releasing incision. After flap reflection, the preparation of osteotomy will be prepared following standard implant system protocol preparation of the osteotomy. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place and the implant itself will be used to gently elevate the sinus up to 3-5mm

Implant placement using crestal sinus approach

Implant placement using osseodensification PROCEDURE

The implant motor will be adjusted on reverse mode with 800 to 1200 rpm. According to the desired implant dimension, Densah bur diameter will be used and then implant placement.

Implant placement using osseodensification

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Edentulous atrophic posterior maxillary ridge.
• Residual alveolar ridge height within 5-6 mm.
• At least 2mm band of keratinized tissue.
• Patients with good oral hygiene.
• Compliant patients to the follow up periods.

You may not qualify if:

• Medically compromised patients.
• Smokers.
• Pregnant females.
• Patients with active periodontal disease.
• Bruxer patients.
• Patients with chronic or active sinusitis.

Sponsors & Collaborators

• Misr International University: lead

Central Study Contacts

Ahmed I Abo El Futtouh, Dr

CONTACT

+201019999983; ahmedkey7@hotmail.com

Inas M El-Zayat, Assoc.Prof

CONTACT

+01222361579; inas.elzayat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical director of implant speciality program

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 17, 2024
• Study Start: August 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share