Survival Rate of 2 Implant-supported Short-span Fixed Partial Dentures

June 2, 2024 updated by: Mohammed El-Sawy, Menoufia University

Survival Rate of 2 Implant-supported Short-span Fixed Partial Dentures in the Anterior Mandible: A Retrospective Study

Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability.1 Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.

Study Overview

Status

Status

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

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

The relationship between implants/ prosthetic components and the surrounding soft and hard tissues is complex and determines the final clinical result. For example, crestal bone resorption, frequently observed following implant placement or following loading, may be related to factors such as the establishment of the biologic width, the macro design of the cervical area of the implant and possible surface treatments, the type of implant/abutment connection, the positioning of the implant in relation to the bone crest, the width of the alveolar ridge, the distance between contiguous implants, the surgical procedure, and the effects of overloading and peri-implantitis. The establishment of the biologic width perse is related to a series of events that results in remodeling of the bone that surrounds the implants, a fact that has been observed by histomorphometry and radiographic analysis.

The aim of the present study was to compare and evaluate the survival rate and crestal bone levels around immediately placed implants in the esthetic zone with delayed, progressive, or immediately placed.

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.
Observational

Enrollment (Estimated)

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.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

N/A

Sampling Method

Probability Sample

Study Population

People over 25 and less than 50 years

Description

Inclusion Criteria:

  • fully dentulous people over 25 who complained of the mobility of 4 mandibular incisor teeth, or partially dentulous people who missed 2 mandibular central incisor teeth and had periodontally affected the neighboring lateral incisor teeth.
  • These individuals were subsequently treated with 2 implants supporting FPDs and following a delayed, progressive, or immediate loading protocol
  • Class 0 or 1 bone defects after tooth extraction, were only included in the study
  • The medical records included data regarding implant type, width, and length, surgical procedure, annual hygienist treatments, radiographs, and implant insertion date

Exclusion Criteria:

  • had less than 1 years of follow-up, had incomplete restorative or surgical data, had non-diagnostic radiographs, had more or less than 4 unit fixed partial denture
  • patients did not present for annual follow-up visits to evaluate oral hygiene measures or treat mechanical or technical complications.
  • Individuals with bone defects class 2, 3, 4, or 5 after mandibular lateral incisor tooth extraction were also excluded.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Group 1
immediately placed implants with a delayed loading protocol. Loading was performed after 3 months.
Other: Loading protocol
The prosthetic restoration and functional loading of the dental implant.
Group 2
immediately placed implants with a progressive loading protocol. Loading was performed after 5 weeks.
Other: Loading protocol
The prosthetic restoration and functional loading of the dental implant.
Group 3
immediately placed implants with an immediate loading protocol. The day of the surgery was also the day of loading.
Other: Loading protocol
The prosthetic restoration and functional loading of the dental implant.

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
Implant survival
Time Frame: 3 years
The implant is present at the follow-up examination but its condition is not specified.
3 years

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.
Menoufia 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.
February 1, 2024

Primary Completion (Estimated)

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 (Estimated)

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.
August 20, 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).
June 2, 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.
June 2, 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.
June 7, 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.
June 7, 2024

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.
June 2, 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.
June 1, 2024

More Information

Terms related to this study

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.
  • ADMNF-0020524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For a reasonable reason after contacting the corresponding author.

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.

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