An interventional study of Tent Pole Technique in Jaw Deformity, sponsored by Nourhan M.Aly. Completed at 1 site in Egypt. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-07-28.
Sponsored by Nourhan M.Aly · Not applicable, Interventional, and Treatment
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.
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.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's enrollment of 12 is below the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →Nourhan M.Aly is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
* 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
* 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
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)
Time frame: 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.
Time frame: 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.
Time frame: 6 months
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Jaw Abnormalities
Nourhan M.Aly