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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03008538
Other study ID # CairoSPR-Aut
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received December 26, 2016
Last updated December 30, 2016
Start date September 2016
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

Studying the comparative effectiveness of socket preservation using autogenous bone graft versus MPM for implant insertion.


Description:

To assess bone quality, stability of implants placed in fresh extraction sockets of mandibular anterior and premorals augmented by MPM (Mineralized Plasmatic Matrix) versus autogenous bone graft (gold standard), at different follow-up periods (0, 3, 6, 9 months).


Recruitment information / eligibility

Status Active, not 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. Patients with mandibular anterior and premolar hopeless teeth indicated for extraction.

3. Evaluated bone height on X.Ray to be (0-4 mm buccal bone dehiscence).

4. Age between 18 and 40 years.

5. Both sexes.

6. Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.

7. Highly motivated patients.

Exclusion criteria:

1. Smokers.

2. Pregnant or lactating females.

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

4. Presence of Para functional habits.

5. History of oral radiotherapy.

6. History of prolonged steroids use

7. Psychological disorders.

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
MPM(Mineralized plasmatic matrix).
Preparation of sticky bone graft by addition of growth factors obtained from patient's vebous blood.
Autogenous Bone Graft
Socket preservation using autogenous bone graft for preservation of bone width and height for future implant insertion.

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 function, to be measured using patient questionnaire. 3 Months. Yes
Secondary Comparative histomorphometric analysis, to be measured using a digital software called (leica QWin 500) and unit of measurements are to be (Pixels). 3 Months. Yes
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