Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy

March 14, 2022 updated by: Louisiana State University Health Sciences Center in New Orleans

Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy: A Randomized, Split-Mouth Clinical Trial

The purpose of this study was to compare the clinical outcomes of teeth deep cleaning or scaling and root planing (SRP) using a periodontal endoscope (Perioscopy®) versus traditional SRP using magnifying loupes for up to twelve months, utilizing a split mouth design.

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-five (25) patients were recruited for the study that exhibited mild to moderate periodontitis. SRP or deep cleaning was rendered by the same experienced hygienist, following random assignment of the left or right half of the mouth to either recieve deep cleaning by using a periodontal endoscope (Perioscopy®) or traditional deep cleaning using magnifying loupes. All the periodontal evaluations were done by the same periodontal resident at baseline, one month, three months, six months, and twelve months after deep cleaning.

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.
25

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

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • LSU Health New Orleans School of Dentistry (Dept of Periodontics)

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • in good general health
  • given a diagnosis of mild-moderate generalized chronic periodontitis per the 1999 world workshop classification of periodontal diseases and conditions
  • required whole mouth SRP
  • teeth had a maximum of 6mm probing pocket depth at any site
  • at least one molar present in each arch, excluding third molars.

Exclusion Criteria:

  • any requirement for antibiotic premedication prior to dental treatment
  • uncontrolled hypertension
  • uncontrolled diabetes
  • subject unwilling to sign the informed consent
  • subject needed any antibiotic intervention for unrelated conditions

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: Other
  • 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.
Experimental: Periodontal Endosccope
One randomly assigned side of the mouth received deep cleaning treatment with the operator using a periodontal endoscope or Perioscopy® for magnification
Device: Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning
Deep cleaning or scaling and root planing (SRP) using a Periodontal Endoscope or Perioscopy® for enhanced visualization, on teeth in one half of the mouth
Active Comparator: Traditional Loupes
One randomly assigned side of the mouth received deep cleaning treatment with the operator using traditional loupe magnification
Device: Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning
Deep cleaning or scaling and root planing (SRP) using tradional loupes for enhanced visualization on teeth, in the other half of the mouth

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
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm
Time Frame: 3 months
Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.
3 months
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.
Time Frame: 3 months
Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.
3 months
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.
Time Frame: 3 months
The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.
3 months
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.
Time Frame: 6 months
Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.
6 months
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.
Time Frame: 6 months
Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.
6 months
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.
Time Frame: 6 months
The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.
6 months
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.
Time Frame: 12 months
Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.
12 months
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.
Time Frame: 12 months
Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.
12 months
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.
Time Frame: 12 months
The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.
12 months

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
Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.
Time Frame: 3 months
Probing pocket depth (in mm) around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.
3 months
Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.
Time Frame: 3 months
Clinical attachment level (in mm) around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.
3 months
Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.
Time Frame: 3 months
Presence or absence of bleeding on probing around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.
3 months
Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.
Time Frame: 6 months
Probing pocket depth (in mm) around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.
6 months
Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.
Time Frame: 6 months
Clinical attachment level (in mm) around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.
6 months
Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.
Time Frame: 6 months
Presence or absence of bleeding on probing around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.
6 months
Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.
Time Frame: 12 months
Probing pocket depth around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.
12 months
Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.
Time Frame: 12 months
Clinical attachment level (in mm) around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.
12 months
Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.
Time Frame: 12 months
Presence or absence of bleeding on probing around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.
12 months

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.
Louisiana State University Health Sciences Center in New Orleans

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: Elizabeth Mayer, RDH,MS, LSUHSC SCHOOL OF DENTISTRY (DEPT. OF PERIODONTICS)

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.
August 17, 2018

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.
March 5, 2020

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.
March 5, 2020

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).
February 10, 2022

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.
March 14, 2022

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.
March 24, 2022

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 24, 2022

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.
March 14, 2022

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.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • IRB#9587

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

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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