Completely Versus Partially Guided Zygomatic Implant

F

Fayoum University

Status

Enrolling

Conditions

Maxillary Deficiency
Alveolar Bone Loss

Treatments

Procedure: completely limiting computer generated surgical three-dimensional guide
Procedure: Partially limiting computer generated surgical three-dimensional guide

Study type

Interventional

Funder types

Other

Identifiers

NCT06227351
Zygomatic Implant

Details and patient eligibility

About

The aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.

Full description

According to World Oral Health Organization (WHO), losing teeth and arch edentulism is the result of a life long history of oral diseases like advanced dental caries and severe periodontal disease. Complete tooth loss estimated global average prevalence is 7% among people aged 20 years and 23% among people aged 60 years or older. Tooth loss lead to bone resorption in all direction. Non-grafting solutions have been developed to reduce risks, morbidity, and treatment time. These types of treatment are often preferred by patients, considering that they may minimize total treatment time and have less morbidity than staged procedures of grafting solutions.One of non-grafting solutions is the zygomatic implants. Zygomatic implants have shown improved clinical results compared with bone grafting in compromised maxillary bone.But the same as any surgical procedure, placing zygomatic implants has potential complication, such as: oro-antral communication, paresthesia or altered sensation of the infra orbital nerve also penetration of the orbital cavity may occur. In order to achieve the optimal position of zygomatic implant, computer-based planning has been introduced with the use of surgical guides. Surgical guides are classified according to design concepts for fabrication of surgical guide to non-limiting, partially limiting design and complete limiting. In partially limiting design,the first drill is used then the surgical guide is removed and the osteotomy and implant placement are completed in freehand while in complete limiting design all the instruments used in surgical procedure during implant placement are restricted. In literature, there is low evidence of using partially guided surgery for zygomatic implant and also of comparing the two designs with each other. the aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients older than 18 years.
  2. Patients with severe alveolar bone atrophy in posterior maxilla (residual alveolar crest less than 4 mm in height, in the area immediately distal to the canine pillar).

Exclusion criteria

  1. Patients with systemic conditions contra-indicating general anesthesia.
  2. Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
  3. Patients with acute maxillary sinus infection or maxillary sinus cyst.
  4. Restricted mouth opening (less than 3 cm inter-arch distance anteriorly).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

12 participants in 2 patient groups

completely limiting computer generated surgical three-dimensional guide
Active Comparator group
Description:
patients in this group will receive zygomatic implant placed in a completely fully guided technique using surgical guide,keys and sleeves.
Treatment:
Procedure: completely limiting computer generated surgical three-dimensional guide
Partially limiting computer generated surgical three-dimensional guide
Active Comparator group
Description:
patients in this group will receive zygomatic implant placed in a partially guided technique using surgical guide.The first drill only will be used with the guide then the guide will be removed and the whole procedure with the remaining drills will be completed in a free hand technique.
Treatment:
Procedure: Partially limiting computer generated surgical three-dimensional guide

Trial contacts and locations

1

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Central trial contact

Mohamed K Ghallab; Alshimaa A Shaban, Professor

Data sourced from clinicaltrials.gov

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