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The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without Platelet Rich Fibrin( PRF)

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ClinicalTrials.gov Identifier: NCT03037125
Recruitment Status : Unknown
Verified January 2017 by Youssef Emad Zaghloul Meshreky, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 31, 2017
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Youssef Emad Zaghloul Meshreky, Cairo University

Brief Summary:

Split crest technique is a technique for horizontal bone augmentation used in case of narrow alveolar ridges as an alternative to the more aggressive techniques such as onlay bone grafting, guided bone regeneration (GBR) and distraction osteogenesis

The study goal is to evaluate whether if there will be any benefit of using platelet rich fibrin (PRF) with the split crest technique regarding bone width gain and healing response in comparison with split crest technique alone, where PRF is considered an autologous, growth factor containing material which is easy to collect and is of low cost.


Condition or disease Intervention/treatment Phase
Ridge Deficiency Procedure: Split Crest with PRF Procedure: Split Crest without PRF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without PRF In Conjunction With Simultaneous Implant Placement In Narrow Alveolar Ridges: A Randomized Controlled Clinical Trial
Estimated Study Start Date : February 1, 2017
Estimated Primary Completion Date : August 15, 2017
Estimated Study Completion Date : January 1, 2018

Arm Intervention/treatment
Active Comparator: Control Arm
Split crest without PRF
Procedure: Split Crest without PRF
Narrow ridges are split to increase the ridge width and immediate implants are placed without grafting

Experimental: Intervention Arm
Split crest with PRF
Procedure: Split Crest with PRF
Narrow ridges are split to increase the ridge width and immediate implants are placed with PRF closing the gap




Primary Outcome Measures :
  1. Bone width gain [ Time Frame: 6 months ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with at least one missing tooth in the maxillary region
  2. All the selected patients have a bucco-palatal width of the edentulous alveolar ridge from 3.5-5.5mm.
  3. All the selected patients have at least 12 mm residual bone height at the edentulous area
  4. The recipient site of the implant should be free from any pathological conditions.
  5. No diagnosed bone disease or medication known to affect bone metabolism.
  6. Patients who are cooperative, motivated, and hygiene conscious.

Exclusion Criteria:

  1. Patients unable to undergo minor oral surgical procedures.
  2. Patients with a history of drug abuse or catabolic drugs.
  3. Patients with a history of psychiatric disorder.
  4. Patients with unrealistic expectations about the esthetic outcome of implant therapy.
  5. Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
  6. Patients in the growth stage with partially erupted teeth.
  7. Patients who have any systemic condition that may contraindicate implant therapy.
  8. Patients who have any habits that might jeopardize the osseointegration process, such as smoking and alcoholism.
  9. Patients with parafunctional habits that produce overload on the implant, such as bruxism and clenching.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037125


Contacts
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Contact: Youssef E Meshreky, Bachelor 01006382121 ext 002 youssefmeshreky@gmail.com

Locations
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Egypt
Faculty of oral and dental medicine, Cairo university Not yet recruiting
Cairo Governorate, Cairo, Egypt, 11311
Contact: Youssef E Meshreky, Bachelor    01006382121 ext 002    youssefmeshreky@gmail.com   
Sponsors and Collaborators
Cairo University

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Responsible Party: Youssef Emad Zaghloul Meshreky, Bachelor, Cairo University
ClinicalTrials.gov Identifier: NCT03037125     History of Changes
Other Study ID Numbers: PERIO 3:7:3
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No