Evaluation of Tent-Pole Grafting Technique for Reconstruction of Mandibular Ridge Vertical Defects

Study Overview
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Brief Summary
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The aim of this study is to evaluate clinically and radio-graphically the efficiency of Tent- Pole grafting technique for reconstruction of anterior or posterior mandibular ridge defects using synthetic bone graft and Platelet Rich Fibrin (PRF) membrane.

Detailed Description
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Various techniques have been described for the reconstruction of large vertical defects before implant placement . In this study we assessed the efficacy of tenting the periosteum and soft tissue matrix with titanium screws maintaining a space for the graft material in order to augment large vertical defects of mandibular ridge (anterior or posterior region) using data from 12 patients . After 6 months we assessed the increase in bone height and density.

Official Title
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Evaluation of Tent-Pole Grafting Technique for Reconstruction of Mandibular Ridge Vertical Defects (Clinical and Radiographic Study)

Conditions
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Jaw Deformity

Intervention / Treatment
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* Procedure: Tent Pole Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with missing lower tooth or teeth and have a related large vertical bony defect . Patients with about 7mm residual bone hight and requiring about 5 mm increase in the vertical height of the mandibular alveolar ridge for future prosthetic rehabilitation. Patients with an acceptable oral hygiene and willing to improve it Exclusion Criteria: Presence of infection or local lesions. Parafunctional habits. Current chemotherapy or radiotherapy. Heavy smokers. Alcohol or drug abuse. Medically compromised patients with diseases that affect passively the clinical procedure or result.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm trial of 12 patients with mandibular large vertical defects treated using synthetic bone graft around titanium screws to tent out the soft tissue matrix.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tent Pole Grafting Technique<br>Bone graft [NanoBone® granulate 0,6 mm (24% Silica / 76% Hydroxylapatite)] is mixed with the patient blood and placed to cover the screws completely, the defect is overcorrected with particulate material in anticipation of future graft resorption. PRF membrane is prepared by: Ten milliliters of whole venous blood will be collected in sterile glass test tubes without anticoagulant. Then the test tubes will be placed in a table centrifuge machine at 3000 revolutions per minute (rpm) for 10 minutes.After separation of PRF, the membrane is prepared compression device. | Procedure: Tent Pole Technique<br>* All patients were operated under local or general anaesthesia according to the case and patient tolerability. The oral cavity was prepared by 0.12% chlorhexidine mouthrinses solution* for thirty seconds. Full thickness incision down to the bone with blade no.15. A periosteal elevator was used to perform mucoperiosteal flap. Gentle elevation of the flap Fixation of the screws over the alveolar ridge with about 5 mm of the screw threads will be exposed Bone graft was mixed with the patient blood and placed to cover the screws completely. PRF membrane was be placed over the grafted sites. Repositioning of the flap and suturing with 3/0 black silk suture material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment using Visual Analogue Scale | Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe) | 2 weeks | 
| Postoperative edema | Edema was evaluated by its ability to pit.The examiner fingers pressed into dependent area of the patient skin for 5 seconds. The finger sinks into the tissue and leave an impression when they are removed. The pitting was graded on a scale of +1 to +4 as follows: 1 (trace) slight indentation rapid return to normal. 2 (mild) the indentation returns to normal in a few seconds. 3 (moderate) 6 mm indentation rebounds in 10-20 seconds. 4 (severe) 8 mm indentation rebounds in more than 30 seconds. | 2 weeks | 
| Radiographic Evaluation for Bone Density using Cone Beam CT | A Cone Beam Computerized Tomography was obtained to assess the gained bone height &density. | 6 months |