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

Not Applicable

Completed

• Conditions: Jaw Deformity
• Interventions: Procedure: Tent Pole Technique

• Registration Number: NCT04192851
• Lead Sponsor: Nourhan M.Aly

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-01-20
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-30
• Study First Submitted: 2019-12-07
• Study First Submitted QC: 2019-12-07
• Study First Posted: 2019-12-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-25
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tent Pole Grafting Technique	Tent Pole Technique	* 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.

Primary Outcome Measures

Name	Time	Method
Radiographic Evaluation for Bone Density using Cone Beam CT	6 months	A Cone Beam Computerized Tomography was obtained to assess the gained bone height \&density.
Pain assessment using Visual Analogue Scale	2 weeks	Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Postoperative edema	2 weeks	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt