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

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

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.

Study Overview

• Status: Completed
• Conditions: Jaw Deformity
• Intervention / Treatment: Procedure: Tent Pole Technique

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21512
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tent Pole Grafting 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.

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Collaborators: Alexandria University
• Investigators: Principal Investigator: Asmaa M Abd ElFattah, BDS, Faculty of Dentistry, Alexandria University, Egypt; Study Chair: Abd El Aziz F Khalil, PhD, Faculty of Dentistry, Alexandria University, Egypt; Study Director: Lydia N.F Melek, PhD, Faculty of Dentistry, Alexandria University, Egypt

Publications and helpful links

General Publications

• Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
• Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70. Erratum In: Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):56.
• Jensen SS, Terheyden H. Bone augmentation procedures in localized defects in the alveolar ridge: clinical results with different bone grafts and bone-substitute materials. Int J Oral Maxillofac Implants. 2009;24 Suppl:218-36.
• Le B, Burstein J, Sedghizadeh PP. Cortical tenting grafting technique in the severely atrophic alveolar ridge for implant site preparation. Implant Dent. 2008 Mar;17(1):40-50. doi: 10.1097/ID.0b013e318166d503.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2019
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: December 7, 2019
• First Submitted That Met QC Criteria: December 7, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 25, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Jaw Abnormalities
• Other Study ID Numbers: Tent-pole graft

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No