Neurosensory Disorder Clinical Trial
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"
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of dentistry ,Cairo university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | electrophysiological assessment of the change in the neurosensory function of the inferior alveolar nerve | 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 | pre-operative assessment (base line) and two weeks postoperative | |
Primary | 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:
Complete absence of sensations. Almost no sensation. Reduced sensation. Almost normal sensation. 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 | clinical assessment of the change in the neurosensory function of inferior alveolar nerve: | 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. |
pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative. | |
Secondary | clinical assessment of the change in the neurosensory function of inferior alveolar nerve : | 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. |
pre-operative assessment and (base line) 1 week,2 weeks, 1 month, three months,six months postoperative. | |
Secondary | clinical assessment of the change in the neurosensory function of inferior alveolar nerve | 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. | pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative. |
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