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Completed

NCT Number: NCT05666414

Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy

The aim of this study was to assess the efficiency of the computer-guided interpositional sandwich osteotomy for the vertical bone gain and effects on vital structures (inferior dental nerve bundle) compared to free hand interpositional osteotomies.

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future University in Egypt

Cairo, New Cairo, 11865, Egypt

About this study

in this research a full digital sandwich osteotomy protocol was conducted to be compared with the conventional protocol. the investigators were seeking to determine the significance of using surgical computer software in sandwich interpositional bone grafting at atrophied posterior mandibles and how efficiently can it affect this technique.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • • Edentulous posterior mandibular ridge with vertical loss of alveolar bone with remaining bone height (4-7 mm) above the mandibular canal
  • Good oral hygiene
  • Highly motivated patients
  • Patients seeking fixed prosthesis at posterior mandibular region.
  • Patients willing for a surgical procedures follow-up with an informed consent
  • Age range 20-65 years

Exclusion criteria

  • • Smokers
  • Individuals with dentulous posterior mandible ridge
  • Medically compromised patients
  • Patients with local pathosis at the surgical area suggested
  • Previously subjected to reconstructive procedures of the posterior mandible

Treatment and study plan

sandwich interpositional bone grafting computer guided

Procedure

performing the 2 vertical and the 1 horizontal osteotomies using a cutting patient specific guide and fixation of the vertically elevated bony segment after gap calculation using patient specific fixation guides

conventional interpositional bone grafting

Procedure

performing the conventional interpositional sandwich osteotomies free-hand and fixation of the mobilized bone segment free-hand

Primary outcomes

  1. amount of vertical bone gain

    Time frame: 4 months

    measure the amount of vertical bone gained after performing the interpositional sandwich osteotomy

Secondary outcomes

  1. neurosensory affection

    Time frame: 4 months

    measure the affection of the inferior alveolar nerve bundle after performing the interpositional sandwich osteotomy

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Assessment of Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy Technique in the Atrophied Posterior Mandible: a Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 27, 2022
Registry last updated
Jan 3, 2023

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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