Sinus Lift Using PTFE Titanium Reinforced Membrane

Evaluation of Direct Sinus Lift Using Ptfe Titanium Reinfored Membrane Assosiated With Immediate Implant Placement (Clinical Trial)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sinus Lift
• Intervention / Treatment: Procedure: Direct sinus lift with titanium reinforced PTFE membrane

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct Sinus elevation using SLA Kit	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): October 20, 2021
• Study Completion (Anticipated): October 20, 2021

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: sinus_lift2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No