Preimplant Site Augmentation Using MPM Versus Autogenous Bone Graft

Bone Resorption Clinical Trial

Official title:

Implant Insertion in Defective Anterior Maxillary Ridge Augmented Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03007069
• Other study ID #: CairoMPM-ABG
• Status: Not yet recruiting
• Phase: N/A
• First received: December 25, 2016
• Last updated: December 30, 2016
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Cairo University
• Contact: n/a
• 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.

Description:

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

-PICO-

Population (P): Patients with defective maxillary alveolar ridge requiring implant insertion.

Intervention (I): 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: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Medically free patients.

2. Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm)

3. Patients with Anterior maxillary defective partially edentulous ridge.

4. Age between 18 and 40 years.

5. Both sexes.

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

7. Patients with an opposing tooth to the pre-implant site.

8. Good oral hygiene.

9. Highly motivated patients.

Exclusion Criteria:

1. Patients allergic to local anesthetic agent.

2. Pregnant or lactating females.

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

4. Presence of any mucosal disease.

5. Presence of parafunctional habits.

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:
• Mineralized plasmatic matrix (MPM).
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, for 10 minutes , Which will result if sticky bone graft consistency after mixing.
• Autogenous bone graft (gold standard).
Exposed implant threads are to be covered with autogenous bone and collagen membrane.

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 esthetic results , outcome will be measure using questionnaire.		5 months	Yes
Secondary	Stability of dental implants , this will be measured using Ostell device in ISQ units.		5 months.	Yes