Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy

Not Applicable

Completed

• Conditions: Periodontitis, Adult
• Interventions: Device: Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning; Device: Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning

• Registration Number: NCT05293301
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

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.

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 Timeline

• Study Start: 2018-08-17
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Study First Submitted: 2022-02-10
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Study First Posted: 2022-03-24
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodontal Endosccope	Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning	One randomly assigned side of the mouth received deep cleaning treatment with the operator using a periodontal endoscope or Perioscopy® for magnification
Traditional Loupes	Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning	One randomly assigned side of the mouth received deep cleaning treatment with the operator using traditional loupe magnification

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.	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.
Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.	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.
Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.	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.

Trial Locations

Locations (1)

LSU Health New Orleans School of Dentistry (Dept of Periodontics); 🇺🇸 New Orleans, Louisiana, United States