Effectiveness Evaluation of the Digital Workflow for Single-implant Immediate Loading

September 1, 2022 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Immediately implantation and immediate prosthesis could preserve the alveolar contour and gingival shape. The visiting time is quiet long. Pre-made prosthesis is a way to shorten the visiting time. But the implant has to be placed precisely. Novel digital workflow integrating dynamic navigation or static surgical guide to process one-visit single -implant immediate loading is possible. The study is to compare the x-guide dynamic navigation system or static guide system which one could assist the surgery more accuracy and place the prosthesis more smoothly.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient older than 18 years old, including both sexes. Every patient has 2 missing teeth in a jaw and one on each side. All the edentulous ridges suit the immediate loading criteria

Description

Inclusion Criteria:

  • 20 to 80 years old
  • Miss two functional opposing teeth in one quadrant or the same jaw
  • The situation of oral tissue satisfies the condition of implant immediate loading.

Exclusion Criteria:

  • catastrophic illness,
  • diabetes,
  • cardiovascular diseases,
  • osteoporosis,
  • head and neck cancer,
  • disabled
  • pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
dynamic navigation group or static guide group

Every patient has 2 missing in one jaw The missing tooth will be restored with one-visit single implant immediate loading.

One implant placed is assisted with dynamic navigation system, and the other one is assisted with static surgical guide.
Device: x-guide dynamic navigation system
One implant placement is assisted with x-guide dynamic navigation system. The other implant placement is assisted with static surgical guide
Other Names:
  • static surgical guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Record visiting time
Time Frame: during procedure
Record the time (minutes) in every clinical procedure
during procedure
Implant success rate
Time Frame: Change in periapical film of the implant on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
No osteointegration of implant
Change in periapical film of the implant on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
Prosthesis success rate
Time Frame: Change in photo on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
Morphology of the restoration
Change in photo on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
surgical complications
Time Frame: Post operation 1 week
pain, swelling, infection after surgery
Post operation 1 week
prosthetic success rates
Time Frame: Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
final pink aesthetic score
Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
Implant stability quotient (ISQ)
Time Frame: Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
implant stability
Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of incision
Time Frame: during the operation
flap or flapless
during the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators

National Health Research Institutes, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-F(II)-20220117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Single Missing Tooth Rehabilitation

Clinical Trials on x-guide dynamic navigation system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe