Graftless Technique in Open Maxillary Sinus Lifting Using PEEK Versus Ti -Meshwork

NCT06846632 | Completed

• 1 other identifier: 33-6-24
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the amount of bone formation with PEEK (intervention group) in comparison with Titanium Meshwork (control group) in maxillary sinus lifting using CBCT and assessment of the biocompatibility of the Meshwork and PEEK with the schniederian membrane integrity.

Conditions

Maxillary Sinus

Keywords

maxillary sinus lifting , PEEK , titanium meshwork

Outcome Measures

Primary Outcomes (1)

• Bone quantity

  assessment of bone quantity using CBCT

  at 6 months of maxillary sinus lifting

Secondary Outcomes (1)

• Compatibility with Schneiderian membrane

  at 6 months of maxillary sinus lifting

Study Arms (2)

placement of titanium meshwork after maxillary sinus lifting

EXPERIMENTAL

placement of titanium meshwork after maxillary sinus lifting

Device: titanium meshwork

placement of PEEK after maxillary sinus lifting

EXPERIMENTAL

placement of PEEK after maxillary sinus lifting

Device: PEEK

Interventions

PEEK DEVICE

placement of PEEK after maxillary sinus lifting

Also known as: poly ether ether ketone

placement of PEEK after maxillary sinus lifting

titanium meshwork DEVICE

placement of titanium meshwork after maxillary sinus lifting

placement of titanium meshwork after maxillary sinus lifting

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height of 3 to 6 mm.
• Patient age ranges from 25 to 50 years.
• ASA physical status I and II.
• Patients willing to be a part of the study and ready to give their consent in writing for the same.
• Patient not complains from maxillary sinusitis
• Patients are free from T.M.J disorders, abnormal oral habits such as bruxism.
• Patient with good oral hygiene.

You may not qualify if:

• Untreated gingivitis, periodontitis.
• Subjected to irradiation in the head and neck area less than 1 year before implantation.
• Untreated periodontitis.
• Insufficient oral hygiene and motivation.
• Pregnant or nursing.
• Bone pathology.
• Patient with blood disease.
• Patient with any systematic disease that may affect normal healing.
• Active infection or severe inflammation in the area intended for implant placement.
• Treated or under treatment with intravenous amino-bisphosphonates.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 14444, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc degree of oral and maxillofacial surgery

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 26, 2025
• Study Start: May 3, 2024
• Primary Completion: October 3, 2024
• Study Completion: November 3, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

EG (1)