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

Jaw Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192851
• Other study ID #: Tent-pole graft
• Status: Completed
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: July 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 30, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Jaw Abnormalities
• Jaw Deformity

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. Review. Erratum in: Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):56. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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