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

NCT03952663 | Unknown DMC

• 1 other identifier: 14422015598557
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurosensory Disorder

Keywords

inferior alveolar nerve lateralization; platelet rich fibrin; posterior atrophic mandible

Outcome Measures

Primary Outcomes (1)

• Subjective assessment of the change in the neurosensory function of inferior alveolar nerve

  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.

  pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative

Secondary Outcomes (3)

• clinical assessment of the change in the neurosensory function of inferior alveolar nerve:

  pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative.

• clinical assessment of the change in the neurosensory function of inferior alveolar nerve :

  pre-operative assessment and (base line) 1 week,2 weeks, 1 month, three months,six months postoperative.

• clinical assessment of the change in the neurosensory function of inferior alveolar nerve

  pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative.

Other Outcomes (1)

• electrophysiological assessment of the change in the neurosensory function of the inferior alveolar nerve

  pre-operative assessment (base line) and two weeks postoperative

Study Arms (2)

Group I

EXPERIMENTAL

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.; Procedure: platelet rich fibrin membrane around the nerve

Group II

ACTIVE COMPARATOR

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.

Interventions

inferior alveolar nerve lateralization and dental implant placement. PROCEDURE

inferior alveolar nerve lateralization for placement of sufficiently long dental implants.

Group I; Group II

platelet rich fibrin membrane around the nerve PROCEDURE

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

Group I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry ,Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Sensation Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eman S Shalaby, ass.lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman S Shalaby, ass.lecturer

CONTACT

+20-01004762274; emmoshalaby@gmail.com

Abdelmoez M Al-Sharkawy, lecturer

CONTACT

+20-01223194207; moezshark@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded ,participant and outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: * Randomized clinical trial. * double blinded, with 1:1 allocation ratio, parallel design.

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 16, 2019
• Study Start: November 28, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

EG (1)