Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy

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: Completed
• Conditions: Periodontitis, Adult
• Intervention / Treatment: 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

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: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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 Outcome Measures

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.	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.	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.	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.	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.	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.	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.	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.	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.	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

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Elizabeth Mayer, RDH,MS, LSUHSC SCHOOL OF DENTISTRY (DEPT. OF PERIODONTICS)

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2018
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: periodontitis; Non-surgical periodontal therapy; scaling, subgingival
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID 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