Clinical trial NCT05293301: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis, Adult
Keywords: periodontitis
scaling, subgingival
Non-surgical periodontal therapy
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, split-mouth, single blinded
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm
timeFrame: 3 months
measure: Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.
timeFrame: 3 months
measure: Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.
timeFrame: 3 months
measure: Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.
timeFrame: 6 months
measure: Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.
timeFrame: 6 months
measure: Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.
timeFrame: 6 months
measure: Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.
timeFrame: 12 months
measure: Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.
timeFrame: 12 months
measure: Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.
timeFrame: 3 months
measure: Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.
timeFrame: 3 months
measure: Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.
timeFrame: 3 months
measure: Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.
timeFrame: 6 months
measure: Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.
timeFrame: 6 months
measure: Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.
timeFrame: 6 months
measure: Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.
timeFrame: 12 months
measure: Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.
timeFrame: 12 months
measure: Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.
timeFrame: 12 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU Health New Orleans School of Dentistry (Dept of Periodontics)
state: Louisiana
Study officials:
affiliation: LSUHSC SCHOOL OF DENTISTRY (DEPT. OF PERIODONTICS)
name: Elizabeth Mayer, RDH,MS
role: PRINCIPAL_INVESTIGATOR
References: