Effect of Two Different Digital Construction Techniques of Implant-assisted Overdentures

December 15, 2024 updated by: Mansoura University

Effect of Two Different Digital Construction Techniques of Implant-assisted Overdentures: a 3-year Prospective Radiographic Study

twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups (n = 10 per group): Group A: received milled mandibular overdenture opposed by maxillary complete denture. Group B: received 3D-printed mandibular overdenture opposed by maxillary acrylic complete denture. peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Mansoura University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All patient wearing maxillary conventional denture.
  • All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
  • A Cone Beam Computed Tomography (CBCT) done to verify the accurate position and success of the inserted implant.
  • They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
  • At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna). This was detected by a tentative jaw relation.
  • All patients are of angel's class I maxillo-mandibular relationships.

Exclusion Criteria:

  • Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
  • Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
  • Long term immunosuppress and corticosteroid drug therapy.
  • Patient with abnormal habits as clenching and bruxism.
  • Smoking patient.
  • Uncooperative patients.
  • Neuromuscular diseases.
  • Patient with problems in TMJ.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: milled mandibular overdenture opposed by maxillary complete denture
A denture base milled from a pre-polymerized block of polymethylmethacrylate (Ivobase CAD) along with milled denture teeth from a block of tooth coloured material PMMA (SR Vivodent CAD).
Radiation: peri implant bone loss was assessed by CBCT
using CBCT, vertical bone loss (VBL) was measured at baseline (T0), at1 year(T1), at 3 years(T3)
Other: posterior ridge resorption was assessed by CBCT
posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.
Active Comparator: 3D-Printed mandibular overdenture
The printer (Rasdent 3d printer) was loaded with material of 3D-printed denture base and 3D- printed denture teeth (Dentca denture teeth shade A2). The mandibular denture teeth were printed as one unit then bonded to the lower printed denture base.
Radiation: peri implant bone loss was assessed by CBCT
using CBCT, vertical bone loss (VBL) was measured at baseline (T0), at1 year(T1), at 3 years(T3)
Other: posterior ridge resorption was assessed by CBCT
posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
peri implant bone loss
Time Frame: at baseline (T0), at1 year(T1), at 3 years(T3)
peri implant bone loss was assessed by CBCT
at baseline (T0), at1 year(T1), at 3 years(T3)
posterior ridge resorption
Time Frame: at baseline (T0), at 1 year( T1), at 3 years (T3).
posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.
at baseline (T0), at 1 year( T1), at 3 years (T3).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A01010024RP

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

Yes

product manufactured in and exported from the U.S.

Yes

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.

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