Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy

Study Overview
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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.

Official Title
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Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy: A Randomized, Split-Mouth Clinical Trial

Conditions
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Periodontitis, Adult

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, split-mouth, single blinded
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periodontal Endosccope<br>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<br>* 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<br>|
| Active Comparator: Traditional Loupes<br>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<br>* Deep cleaning or scaling and root planing (SRP) using tradional loupes for enhanced visualization on teeth, in the other half of the mouth<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, scaling, subgingival, Non-surgical periodontal therapy