Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy
Primary Purpose
Periodontitis, Adult
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning
Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning
Sponsored by
About this trial
This is an interventional other trial for Periodontitis, Adult focused on measuring periodontitis, scaling, subgingival, Non-surgical periodontal therapy
Eligibility Criteria
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
Sites / Locations
- LSU Health New Orleans School of Dentistry (Dept of Periodontics)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Periodontal Endosccope
Traditional Loupes
Arm Description
One randomly assigned side of the mouth received deep cleaning treatment with the operator using a periodontal endoscope or Perioscopy® for magnification
One randomly assigned side of the mouth received deep cleaning treatment with the operator using traditional loupe magnification
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05293301
First Posted
February 10, 2022
Last Updated
March 14, 2022
Sponsor
Louisiana State University Health Sciences Center in New Orleans
1. Study Identification
Unique Protocol Identification Number
NCT05293301
Brief Title
Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy
Official Title
Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy: A Randomized, Split-Mouth Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2018 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Adult
Keywords
periodontitis, scaling, subgingival, Non-surgical periodontal therapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, split-mouth, single blinded
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periodontal Endosccope
Arm Type
Experimental
Arm Description
One randomly assigned side of the mouth received deep cleaning treatment with the operator using a periodontal endoscope or Perioscopy® for magnification
Arm Title
Traditional Loupes
Arm Type
Active Comparator
Arm Description
One randomly assigned side of the mouth received deep cleaning treatment with the operator using traditional loupe magnification
Intervention Type
Device
Intervention Name(s)
Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning
Intervention Description
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
Intervention Name(s)
Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning
Intervention Description
Deep cleaning or scaling and root planing (SRP) using tradional loupes for enhanced visualization on teeth, in the other half of the mouth
Primary Outcome Measure Information:
Title
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm
Description
Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.
Time Frame
3 months
Title
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.
Description
Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.
Time Frame
3 months
Title
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.
Description
The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.
Time Frame
3 months
Title
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.
Description
Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.
Time Frame
6 months
Title
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.
Description
Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.
Time Frame
6 months
Title
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.
Description
The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.
Time Frame
6 months
Title
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.
Description
Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.
Time Frame
12 months
Title
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.
Description
Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.
Time Frame
12 months
Title
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.
Description
The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.
Description
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.
Time Frame
3 months
Title
Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.
Description
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.
Time Frame
3 months
Title
Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.
Description
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.
Time Frame
3 months
Title
Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.
Description
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.
Time Frame
6 months
Title
Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.
Description
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.
Time Frame
6 months
Title
Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.
Description
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.
Time Frame
6 months
Title
Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.
Description
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.
Time Frame
12 months
Title
Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.
Description
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.
Time Frame
12 months
Title
Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Mayer, RDH,MS
Organizational Affiliation
LSUHSC SCHOOL OF DENTISTRY (DEPT. OF PERIODONTICS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSU Health New Orleans School of Dentistry (Dept of Periodontics)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy
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