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Completed

NCT Number: NCT05293301

Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy

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.

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Key information

Conditions

Periodontitis, Adult Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LSU Health New Orleans School of Dentistry (Dept of Periodontics)

New Orleans, Louisiana, 70119, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning

Device

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

Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning

Device

Deep cleaning or scaling and root planing (SRP) using tradional loupes for enhanced visualization on teeth, in the other half of the mouth

Primary outcomes

  1. Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm

    Time frame: 3 months

    Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.

  2. Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.

    Time frame: 3 months

    Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.

  3. Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.

    Time frame: 3 months

    The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.

  4. Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.

    Time frame: 6 months

    Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.

  5. Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.

    Time frame: 6 months

    Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.

  6. Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.

    Time frame: 6 months

    The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.

  7. Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.

    Time frame: 12 months

    Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.

  8. Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.

    Time frame: 12 months

    Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.

  9. Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.

    Time frame: 12 months

    The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.

Secondary outcomes

  1. Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.

    Time frame: 3 months

    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.

  2. Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.

    Time frame: 3 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.

  3. Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.

    Time frame: 3 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.

  4. Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.

    Time frame: 6 months

    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.

  5. Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.

    Time frame: 6 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.

  6. Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.

    Time frame: 6 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.

  7. Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.

    Time frame: 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.

  8. Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.

    Time frame: 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.

  9. Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2022
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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