Effect of Implant Position on Clinical Outcomes

December 13, 2023 updated by: Mansoura University

Effect of Implant Position on Clinical Outcomes of Implant-retained Mandibular Overdenture. A 3-year Retrospective Study

the study aims to investigate the clinical influence of different implant locations; lateral incisor, canine, and first premolar areas; supporting 2-implant retained mandibular over-dentures with locator attachment on prosthesis retention and peri-implant health.

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

the study aims to investigate the clinical influence of different implant locations; lateral incisor, canine, and first premolar areas; supporting 2-implant retained mandibular over-dentures with locator attachment on prosthesis retention and peri-implant health.

  • Thirty-six edentulous patients will be recalled from the database set of the clinic of the removable prosthodontic department, Faculty of Dentistry, Mansoura University. Patients will be recruited from previous studies, having two-implant mandibular overdentures.
  • All selected patients with the following criteria: mandibular two implants retained overdenture opposing complete edentulous maxillary arch, attended the previous follow-up recalls with previous CBCT examination. Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will be excluded from the study.
  • The patients will be grouped based on the implant position:

Group I (12 patients): patients having mandibular two implants in lateral incisor positions.

Group II (12 patients): patients having mandibular two implants in the canine positions.

Group III (12 patients): patients having mandibular two implants in the premolar positions.

  • Implant-retained overdenture construction procedures:

    1. Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin. The mandibular tray was fabricated with holes above the implant sites and molded with green impression compound modeling plastic.
    2. Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.
    3. Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.

    4. The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing.

      Method of evaluation

  • Assessment of the peri-implant soft tissue health including Plaque index, Probing depth, and bleeding index. Also, evaluation of the peri-implant bone loss was done at one, two, and three years after insertion using a CBCT, following the methodology described by Elsyad et al.
  • Measurements of retention values: using the device of measuring the clinical retentive forces.
  • Assessment of patient satisfaction and Oral Health-Related Quality of Life: using a visual analog scale (VAS) questionnaire.

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.
36

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, 54790
        • Khloud Ezzat

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:

  • mandibular two implants retained overdenture opposing complete edentulous maxillary arch.
  • patients who attended the previous follow-up recalls with previous CBCT examination

Exclusion Criteria:

  • Patients who didn't attend previous follow-up recalls.
  • patients who didn't perform radiographic follow-up.
  • patients who had para-functional habits.

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: Double

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: lateral incisor group
patients having mandibular two implants in lateral incisor positions.
Device: overdenture retained by locator attachments.

• Implant-retained overdenture construction procedures:

  1. Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin.
  2. Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.
  3. Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.
  4. The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing.
Active Comparator: canine group
patients having mandibular two implants in the canine positions.
Device: overdenture retained by locator attachments.

• Implant-retained overdenture construction procedures:

  1. Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin.
  2. Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.
  3. Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.
  4. The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing.
Active Comparator: premolar group
patients having mandibular two implants in the premolar positions.
Device: overdenture retained by locator attachments.

• Implant-retained overdenture construction procedures:

  1. Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin.
  2. Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.
  3. Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.
  4. The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing.

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 bleeding
Time Frame: 3years
bleeding index
3years
peri-implant probing depth
Time Frame: 3 years
measurements of probing depth in mm
3 years
overdenture retention
Time Frame: 3 years
Measurements of retention values: using the device of measuring the clinical retentive forces
3 years
peri-implant plaque
Time Frame: 3 years
modified plaque index
3 years
patient satisfaction
Time Frame: 3 years
Assessment of patient satisfaction and Oral Health-Related Quality of Life: using a visual analog scale (VAS) questionnaire
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
bone loss
Time Frame: 3 years
evaluation of the peri-implant bone loss in mm
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.
Mansoura University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Khloud Ezzat, PhD, lecturer

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.
January 10, 2020

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.
January 30, 2023

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.
October 1, 2023

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, 2023

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, 2023

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 12, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
December 20, 2023

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 13, 2023

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, 2023

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.
  • A01011023RP

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.

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