NCT05293301

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

February 10, 2022

Last Update Submit

March 14, 2022

Conditions

Periodontitis, Adult

Keywords

periodontitisscaling, subgingivalNon-surgical periodontal therapy

Outcome Measures

Primary Outcomes (9)

  • Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.

    12 months

Secondary Outcomes (9)

  • Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.

    3 months

  • Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.

    3 months

  • Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.

    3 months

  • Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.

    6 months

  • Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Periodontal Endosccope

EXPERIMENTAL

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

Traditional Loupes

ACTIVE COMPARATOR

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

Interventions

Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaningDEVICE

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

Periodontal Endosccope
Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaningDEVICE

Deep cleaning or scaling and root planing (SRP) using tradional loupes for enhanced visualization on teeth, in the other half of the mouth

Traditional Loupes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSU Health New Orleans School of Dentistry (Dept of Periodontics)

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Mayer, RDH,MS

    LSUHSC SCHOOL OF DENTISTRY (DEPT. OF PERIODONTICS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Follow up re-evaluation visits were performed by the same resident \~1month, 3 months, 6 months, and 1 year, who was blinded to lknowing which side of the mouth recieved what type of deep cleaning treatment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: prospective, randomized, split-mouth, single blinded
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

March 24, 2022

Study Start

August 17, 2018

Primary Completion

March 5, 2020

Study Completion

March 5, 2020

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)