Evaluation of Minimally Invasive Alveolar Augmentation Procedure of Anterior Maxillary Ridge Using Tunneling Surgical Technique

Evaluation of Alveolar Augmentation Using Tunneling Surgical Technique



Sponsors

Lead Sponsor



Source

Cairo University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be
augmented by minimally invasive tunneling technique utilizing MPM as bone graft and patients
followed up for 14 weeks .

Overall Status

Not yet recruiting

Start Date

2018-05-01

Completion Date

2019-04-01

Primary Completion Date

2018-07-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

bone formation
14 weeks

Enrollment

10

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

sticky bone prepared by centrifuge patient blood and mixing with xinograft

Arm Group Label

tunneling surgical technique

Other Name

mpm


Eligibility

Criteria

Inclusion Criteria:

- Patients' age range from 18-60 years.

- Patients with horizontal bone defect in anterior maxillary area.

- Patients should be free from any systemic disease that may affect normal healing of
bone and predictable outcome.

Exclusion Criteria:

• Patients with systemic diseases as history of radiation therapy or chemotherapy,
hematological disorders and autoimmune diseases (may affect normal healing).

Gender

All

Minimum Age

18 Years

Maximum Age

60 Years

Healthy Volunteers

No


Overall Contact

Last Name

hussien amer elkady, B.D.S

Phone

01141178095

Email



Verification Date

2018-04-01

Lastchanged Date

2018-04-07

Firstreceived Date

2018-03-29

Responsible Party

Responsible Party Type

Sponsor-Investigator

Investigator Affiliation

Cairo University

Investigator Full Name

Hussien Amer Elkady

Investigator Title

dentist


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

tunneling surgical technique

Arm Group Type

Experimental


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

tarek elghareeb


Reference

Citation

Nevins ML, Camelo M, Nevins M, Schupbach P, Friedland B, Camelo JM, Kim DM. Minimally invasive alveolar ridge augmentation procedure (tunneling technique) using rhPDGF-BB in combination with three matrices: a case series. Int J Periodontics Restorative Dent. 2009 Aug;29(4):371-83.

PMID

19639058


Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

March 29, 2018

Study First Submitted Qc

April 7, 2018

Study First Posted

April 13, 2018

Last Update Submitted

April 7, 2018

Last Update Submitted Qc

April 7, 2018

Last Update Posted

April 13, 2018


ClinicalTrials.gov processed this data on April 13, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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