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

NCT04192851 | Completed

• 1 other identifier: Tent-pole graft
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaw Deformity

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Tent Pole Grafting Technique

EXPERIMENTAL

* 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

Interventions

Tent Pole Technique PROCEDURE

* 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

Tent Pole Grafting Technique

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (4)

• 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.

  PMID: 19885447 BACKGROUND

• Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.

  PMID: 19885448 BACKGROUND

• 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.

  PMID: 18437791 BACKGROUND

• 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.

  PMID: 18332757 BACKGROUND

MeSH Terms

Conditions

Jaw Abnormalities

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Asmaa M Abd ElFattah, BDS

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Abd El Aziz F Khalil, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Lydia N.F Melek, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of Dental Public Health

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2019
• First Posted: December 10, 2019
• Study Start: January 20, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 30, 2019
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

EG (1)