Sinus Lift Using PTFE Titanium Reinforced Membrane

Overview

Various attempts have been implemented using different materials and techniques to augment the maxillary sinus floor enhancing autogenous bone formation to allow proper dental implant positioning. The aim of this study is to evaluate the sinus lift procedure using polytetrafluoroethylene (PTFE) titanium-reinforced membrane to maintain the space formed after Schneiderian membrane elevation followed by immediate implant placement.

Full Title of Study: “Evaluation of Direct Sinus Lift Using Ptfe Titanium Reinfored Membrane Assosiated With Immediate Implant Placement (Clinical Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 20, 2021

Interventions

  • Procedure: Direct sinus lift with titanium reinforced PTFE membrane
    • Implants will be placed immediately after sinus lifting procedure and maintaining the sinus membrane in position using PTFE titanium reinforced membrane.

Arms, Groups and Cohorts

  • Experimental: Direct Sinus elevation using SLA Kit

Clinical Trial Outcome Measures

Primary Measures

  • Change in implant stability
    • Time Frame: at baseline and 6 months
    • It will be measured using Osstell
  • Change in bone formation
    • Time Frame: at baseline and 6 months
    • It will be measured uisng CBCT on Demand 3d software
  • Change in bone height
    • Time Frame: at baseline and 6 months
    • It will be measured uisng CBCT on Demand 3d software
  • Change in bone density
    • Time Frame: at baseline and 6 months
    • It will be measured uisng CBCT on Demand 3d software

Participating in This Clinical Trial

Inclusion Criteria

  • Patients of both genders requiring implant placement in posterior maxilla – Age range: 40-60 years. – Good oral hygiene – Healthy maxillary sinus free from pathology – The minimum crestal bone height is (4-6) mm – Patients who are willing and fully capable to comply with the study protocol. Exclusion Criteria:

  • Sinus infection – Tumors or pathologic lesions in sinus – Severe allergic rhinitis. – Chronic topical steroid use. – Radiation therapy. – Psychologic / mental impairment – Acute infection (periodontitis or mucosal infection – Patients on radiotherapy or chemotherapy. – Alcohol or drug abuse. – Patient with systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.) – Smokers – Parafuctional habits

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hams Hamed Abdelrahman
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician – Alexandria University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.