Periodontitis, AdultNCT05293301
Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy
A study testing Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning and Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning in people with Periodontitis, Adult, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning and Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2018to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Health New Orleans School of Dentistry (Dept of Periodontics)
New Orleans, Louisiana, 70119
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis, Adult
- Being tested
- 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
- Keywords
- periodontitis, scaling, subgingival, Non-surgical periodontal therapy
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaningDevice
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 cleaningDevice
Deep cleaning or scaling and root planing (SRP) using tradional loupes for enhanced visualization on teeth, in the other half of the mouth
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Endosccope | Experimental | One randomly assigned side of the mouth received deep cleaning treatment with the operator using a periodontal endoscope or Perioscopy® for magnification Receives: Device: Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning |
| Traditional Loupes | Active comparator | One randomly assigned side of the mouth received deep cleaning treatment with the operator using traditional loupe magnification Receives: Device: Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start17 Aug 2018
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, split-mouth, single blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Mayer, RDH,MS, Principal investigator, LSUHSC SCHOOL OF DENTISTRY (DEPT. OF PERIODONTICS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293301
- Sponsor's protocol ID
- IRB#9587
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy: A Randomized, Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT05293301
- Acronym / sponsor ID
- IRB#9587
- Conditions
- Periodontitis, Adult
- Keywords
- periodontitis, scaling, subgingival, Non-surgical periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, split-mouth, single blinded
| Arm | Type | Receives |
|---|---|---|
| Periodontal Endosccope | Experimental | Device: Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaningOne randomly assigned side of the mouth received deep cleaning treatment with the operator using a periodontal endoscope or Perioscopy® for magnification |
| Traditional Loupes | Active comparator | Device: Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaningOne randomly assigned side of the mouth received deep cleaning treatment with the operator using traditional loupe magnification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaningDeep cleaning or scaling and root planing (SRP) using a Periodontal Endoscope or Perioscopy® for enhanced visualization, on teeth in one half of the mouth | Device | Periodontal Endosccope |
| Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaningDeep cleaning or scaling and root planing (SRP) using tradional loupes for enhanced visualization on teeth, in the other half of the mouth | Device | Traditional Loupes |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Mayer, RDH,MS principal investigator
LSUHSC SCHOOL OF DENTISTRY (DEPT. OF PERIODONTICS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning and Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning in people with Periodontitis, Adult, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm (time frame: 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.