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

Primary Purpose

Jaw Deformity

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Tent Pole Technique

About this trial

This is an interventional treatment trial for Jaw Deformity

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tent Pole Grafting Technique

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

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.

Radiographic Evaluation for Bone Density using Cone Beam CT

A Cone Beam Computerized Tomography was obtained to assess the gained bone height &density.

Secondary Outcome Measures

Full Information

NCT ID

NCT04192851

First Posted

December 7, 2019

Last Updated

July 25, 2020

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04192851

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

January 20, 2019 (Actual)

Primary Completion Date

November 15, 2019 (Actual)

Study Completion Date

November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Jaw Deformity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tent Pole Grafting Technique

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Tent Pole Technique

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain assessment using Visual Analogue Scale

Description

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

Title

Postoperative edema

Description

Time Frame

2 weeks

Title

Radiographic Evaluation for Bone Density using Cone Beam CT

Description

A Cone Beam Computerized Tomography was obtained to assess the gained bone height &density.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asmaa M Abd ElFattah, BDS

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Abd El Aziz F Khalil, PhD

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lydia N.F Melek, PhD

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry, Alexandria University

City

Alexandria

ZIP/Postal Code

21512

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

19885447

Citation

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.

Results Reference

background

PubMed Identifier

19885448

Citation

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

Results Reference

background

PubMed Identifier

18437791

Citation

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.

Results Reference

background

PubMed Identifier

18332757

Citation

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.

Results Reference

background

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

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