Clinical trial NCT04192851: 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
Overall status: COMPLETED
Phase: NA
Conditions: Jaw Deformity
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2019-12-10
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain assessment using Visual Analogue Scale
timeFrame: 2 weeks
measure: Postoperative edema
timeFrame: 2 weeks
measure: Radiographic Evaluation for Bone Density using Cone Beam CT
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Asmaa M Abd ElFattah, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Abd El Aziz F Khalil, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Lydia N.F Melek, PhD
role: STUDY_DIRECTOR
References:
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.
citation: Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
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.
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.