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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ridge Deficiency
• Intervention / Treatment: Procedure: Split Crest without PRF; Procedure: Split Crest with PRF

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youssef E Meshreky, Bachelor; Phone Number: 002 01006382121; Email: youssefmeshreky@gmail.com

Study Locations

• Egypt
  • Cairo
    • Cairo Governorate, Cairo, Egypt, 11311
      • Faculty of oral and dental medicine, Cairo university
      • Contact: Youssef E Meshreky, Bachelor; Phone Number: 002 01006382121; Email: youssefmeshreky@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone width gain	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2017
• Primary Completion (ANTICIPATED): August 15, 2017
• Study Completion (ANTICIPATED): January 1, 2018

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (ESTIMATE): January 31, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PERIO 3:7:3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No