Sinus Lift Using PTFE Titanium Reinforced Membrane

Sinus Lift Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05044260
• Other study ID #: sinus_lift2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 20, 2021

Study information

• Verified date: September 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sinus Lift

Intervention

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.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

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