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Effect of Platelet Rich Fibrin Membrane on the Neurosensory Dysfunction After IAN Lateralization for Implant Placement.

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ClinicalTrials.gov Identifier: NCT03952663
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Eman Sayed Ahmed Shalaby, Cairo University

Brief Summary:

In many cases the bone of the edentulous posterior mandibular regions is atrophied such that sufficiently long fixtures cannot be placed without encroaching on the inferior alveolar nerve so rehabilitation of these regions with severe ridge atrophy represents anatomical, surgical, and biological difficulties, and provides a challenge to the dental surgeon.

Several surgical techniques have been employed in an attempt to allow implant placement in these regions. one of these techniques is inferior alveolar nerve transposition or lateralization.

The lateralization of the inferior alveolar nerve has the advantages of that it allow placement of longer implants which gives better stability,but this technique has the disadvantage of high risk of temporary or permanent inferior alveolar nerve dysfunction.

In most of the cases of inferior alveolar nerve lateralization it is directly repositioned on the implant surface or a bone graft is placed in between them.

In a previous study on dogs found that presence of a resorbable membrane between the inferior alveolar nerve and the implant surface lead to the formation of a soft tissue zone between them while in the group where no membrane was used there was intimate contact between them.This intimate contact may lead to the dysfunction symptoms,also the intimate contact between the implant threads and the nerve act as a source of chronic irritation.

Platelet rich fibrin membrane is a platelet concentrate which allow slow and sustained release of high quantities of growth factors over long period of time thus improves healing of hard and soft tissue and optimizing wound healing.

in this study we will assess the effect of platelet rich fibrin membrane on the improvement of the neurosensory disturbances which occur after inferior alveolar nerve lateralization which considered as the main disadvantage of this technique.


Condition or disease Intervention/treatment Phase
Neurosensory Disorder Procedure: inferior alveolar nerve lateralization and dental implant placement. Procedure: platelet rich fibrin membrane around the nerve Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Randomized clinical trial.
  • double blinded, with 1:1 allocation ratio, parallel design.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double blinded ,participant and outcomes assessor
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Platelet Rich Fibrin Membrane on the Neurosensory Dysfunction Following Inferior Alveolar Nerve Lateralization for Implant Placement"A Randomized Controlled Trial"
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: Group I
inferior alveolar nerve lateralization for dental implant placement ,and platelet rich fibrin membrane is placed around the nerve.
Procedure: inferior alveolar nerve lateralization and dental implant placement.
inferior alveolar nerve lateralization for placement of sufficiently long dental implants.

Procedure: platelet rich fibrin membrane around the nerve
platelet rich fibrin membrane is prepared from the patient's blood and placed around the nerve.

Active Comparator: Group II
inferior alveolar nerve lateralization for dental implant placement without placement of platelet rich fibrin membrane around the nerve.
Procedure: inferior alveolar nerve lateralization and dental implant placement.
inferior alveolar nerve lateralization for placement of sufficiently long dental implants.




Primary Outcome Measures :
  1. Subjective assessment of the change in the neurosensory function of inferior alveolar nerve [ Time Frame: pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative ]

    a 10 cm, 5 degree visual analogue scale with divisions at 2.5 cm intervals, the divisions on the VAS was:

    1. Complete absence of sensations.
    2. Almost no sensation.
    3. Reduced sensation.
    4. Almost normal sensation.
    5. Fully normal sensation. Patients were asked to mark "x" on the line at each testing session that represent their opinion about sensation of the lower lip.


Secondary Outcome Measures :
  1. clinical assessment of the change in the neurosensory function of inferior alveolar nerve: [ Time Frame: pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative. ]

    Static light touch detection test:

    using the von-Frey technique with the Semmes-Weinstein monofilaments, a series of nylon monofilaments of varying thickness that exert different pressures when pressed against the skin.

    the patient closes his eyes and says "yes" or "no" response if he feels a light touch, the patient should respond to two of three correct as an appropriate response. If not, the process should be repeated with increasingly stiffer monofilaments.


  2. clinical assessment of the change in the neurosensory function of inferior alveolar nerve : [ Time Frame: pre-operative assessment and (base line) 1 week,2 weeks, 1 month, three months,six months postoperative. ]

    Brush stroke discrimination test:

    the brush is rubbed across the tested area in anterior or posterior direction and the patient will give negative or positive response and determine the direction of the stroke.


  3. clinical assessment of the change in the neurosensory function of inferior alveolar nerve [ Time Frame: pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative. ]
    Tactile discrimination test (two point discrimination test) the two points of the caliper are opened progressively in 1 mm increments until the patient can discriminate two points of contact at which the distance between the two points is recorded.


Other Outcome Measures:
  1. electrophysiological assessment of the change in the neurosensory function of the inferior alveolar nerve [ Time Frame: pre-operative assessment (base line) and two weeks postoperative ]
    electro-somatosensory evoked potential test of the inferior alveolar nerve ,the test will be performed in the neurophysiology unit ,cairo university the latency and amplitude of each evoked potential are measured



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients requiring dental implants placement in the posterior region and has insufficient bone height above the inferior alveolar canal to accommodate for implant placement.
  • Patients should be free from any systemic conditions that may affect normal healing.

Exclusion Criteria:

  • Patients with systematic disease that may complicate healing.
  • Uncontrolled diabetic patient.
  • Patients with advanced osteoporosis.
  • Patients under bisphosphonates treatment.
  • Heavy smoker patients.

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): NCT03952663


Contacts
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Contact: Eman S Shalaby, ass.lecturer +20-01004762274 emmoshalaby@gmail.com
Contact: Abdelmoez M Al-Sharkawy, lecturer +20-01223194207 moezshark@gmail.com

Locations
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Egypt
Faculty of dentistry ,Cairo university Recruiting
Cairo, Egypt
Contact: Eman S Shalaby, ass.lecturer    +20-01004762274    emmoshalaby@gmail.com   
Contact: Abdelmoez Al-Sharkawy, lecturer    +20-01223194207    moezshark@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Eman S Shalaby, ass.lecturer faculty of dentistry Cairo university

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Responsible Party: Eman Sayed Ahmed Shalaby, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03952663     History of Changes
Other Study ID Numbers: 14422015598557
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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

Keywords provided by Eman Sayed Ahmed Shalaby, Cairo University:
inferior alveolar nerve lateralization
platelet rich fibrin
posterior atrophic mandible

Additional relevant MeSH terms:
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Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms