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NCT Number: NCT04192851

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

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.

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Key information

Conditions

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

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Pain assessment using Visual Analogue Scale

    Time frame: 2 weeks

    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. Postoperative edema

    Time frame: 2 weeks

    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.

  3. Radiographic Evaluation for Bone Density using Cone Beam CT

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2019
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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