Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy

NCT ID: NCT05293301

Last Updated: 2022-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-17

Study Completion Date

2020-03-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Periodontitis, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized, split-mouth, single blinded
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Periodontal Endosccope

One randomly assigned side of the mouth received deep cleaning treatment with the operator using a periodontal endoscope or Perioscopy® for magnification

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Traditional Loupes

One randomly assigned side of the mouth received deep cleaning treatment with the operator using traditional loupe magnification

Group Type ACTIVE_COMPARATOR

Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Mayer, RDH,MS

Role: PRINCIPAL_INVESTIGATOR

LSUHSC SCHOOL OF DENTISTRY (DEPT. OF PERIODONTICS)

Locations

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

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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IRB#9587

Identifier Type: -

Identifier Source: org_study_id

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