Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft

Bone Resorption Clinical Trial

— MPM  

Official title:

Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft (A Randomized Clinical Trial Comparative Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03014388
• Other study ID #: CairoU MPM
• Status: Not yet recruiting
• Phase: N/A
• First received: January 5, 2017
• Last updated: January 5, 2017
• Start date: January 2017
• Est. completion date: October 2017

Study information

• Verified date: December 2016
• Source: Cairo University
• Contact: refaat ragab, Master
• Phone: 01111175536
• Email: refaat.ragab.rr[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards in sinus Lift procedures for future implant insertion.

Description:

To study the effectiveness of MPM in ridge augmentation with implant insertion compared with autogenous bone graft.

-PICO Population(P) : Patients with defective posterior maxillary alveolar ridge. Intervention (I) :Implant placement and ridge augmentation with MPM. Comparator (C) : Autogenous bone graft. Outcome (O) : Patient satisfaction - Implant stability.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Patients systemically free.

2. Patients with posterior maxillary defective ridges indicated for sinus lift procedure.

3. Cases with 5 mm bone height or less are included in the study.

4. Age between 18 and 50 years.

5. Both sexes.

6. Patients physically able to tolerate surgical and restorative procedures.

7. Good oral hygiene.

8. Highly motivated patients.

Exclusion Criteria:

1. Patients allergic to local anesthetic agent.

2. Medium and heavy smokers.

3. Pregnant females.

4. Presence of any pathosis in the pre-implant site.

5. Presence of any mucosal disease.

6. History of oral radiotherapy.

7. History of prolonged steroids use.

8. Psychological disorders.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Resorption

Intervention

Other:
• autogenous bone
Autogenous bone graft (gold standard). sinus lift with autogenous bone.
• Mineralized plasmatic matrix
By using venoud blood from the patient, together with bone graft, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction regarding aesthetic results will be measured using questionnaire.	outcome will be measure using questionnaire.	9 months	Yes
Secondary	Stability of dental implants.	will be measured using OSTELL Device.	5 months	Yes