NCT02810184

Brief Summary

The investigators aim to determine the level of total bone volume remodeling at 6, 24 and 36 months post-surgery in patients who underwent immediate prosthetic rehabilitation through a cranial bone-grafted maxilla in combination with immediate provisional implant (IPI) placement.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

6.5 years

First QC Date

June 13, 2016

Last Update Submit

February 23, 2022

Conditions

Severely Atrophic Jaw

Keywords

bone augmentationlong-term bone volume changesimmediate provisional implant

Outcome Measures

Primary Outcomes (1)

  • mean total bone volume changes (%)

    6, 24, and 36 months post surgery

Secondary Outcomes (8)

  • correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes

    short-term (6 months)

  • correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes

    long-term (24 months)

  • correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes

    long-term (36 months)

  • correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes

    short-term (6 months)

  • correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes

    long-term (24 months)

  • +3 more secondary outcomes

Study Arms (1)

CBCT arm

all participating patients receive an additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume

Radiation: cone-beam computed tomography (CBCT)

Interventions

cone-beam computed tomography (CBCT)RADIATION

additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume

CBCT arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of all ages
  • Patients with moderate to extreme bone atrophy of the jaw (class IV to VI according to Cawood and Howell (Cawood \& Howell, 1988), caused by terminal periodontitis or edentulism
  • Patients requiring bone augmentation procedures through cranial bone-grafting for jaw reconstruction
  • Patients requesting immediate prosthetic rehabilitation, through the placement of an immediate provisional implant (IPI)-supported fixed bridge (immediate loading)

You may not qualify if:

  • Patients not fulfilling abovementioned criteria
  • Patients with severe uncontrollable diabetes
  • Patients with a smoking habit of \>10 cigarettes/day
  • Patients with severe sinusitis problems
  • Patients with insufficient cranial bone thickness
  • Patients with bone remodeling or systemic diseases, or undergoing systematically administered treatments affecting bone remodeling
  • Patients in whom postoperative complications (e.g. sinusitis, infections) occurred, will be excluded from the analysis, since these could be responsible for short-term bone volume loss confounding long-term results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Location

Study Officials

  • Johan Abeloos, MD, PhD

    Head of Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department, Division of Maxillofacial surgery

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 22, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2022

Study Completion

July 1, 2023

Last Updated

February 28, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)