PeriodontitisNCT03074565
Ultrasonic Versus Ultrasonic+ for Effective Sanative Therapy
A study testing Ultrasonic alone and Ultrasonic+ in people with Periodontitis and Periodontal Pocket, run by Brock University at 2 sites in Canada.
Trial summary
Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Non-surgical sanative therapy using a combination treatment of hand and ultrasonic instrumentation is the primary treatment option for patients with periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontal Pocket
- What is being tested?
- Ultrasonic alone and Ultrasonic+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesCanada
- Study dates
- 1 May 2017to 5 Feb 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both males and females age 19 years or older who are undergoing sanative therapy for moderate to severe chronic periodontitis are eligible.
- Chronic periodontitis has been classified as localized or generalized depending on whether <30% or >30% of sites are involved.
- Severity is based on the amount of clinical attachment loss (CAL) and is designated as slight (1-2 mm CAL), moderate (3-4 mm CAL) or severe (> 5 mm CAL).
Who cannot join
- Patients with dental implants,
- pregnancy,
- a recent history of antibiotic use (within 3 months prior to treatment) and
- inability to give consent for the study.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery
Fonthill, Ontario, L0S1E5
Brock University
St. Catharines, Ontario, L2S3A1
About this study
Official title: Comparison of Ultrasonic Versus Hand Instrumentation Plus Ultrasonic for Effective Sanative Therapy
Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Non-surgical sanative therapy using a combination treatment of hand and ultrasonic instrumentation is the primary treatment option for patients with periodontitis. However, the hand-held instrumentation requires continuous sharpening for optimal outcomes, which introduces tremendous variability as well as a large increase in time spent by the treating dental hygienists. Therefore, this study aimed to determine if ultrasonic instrumentation alone can provide similar improvements to periodontal outcomes compared to ultrasonic plus hand instrumentation.
Read the detailed description
Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Bacteria and the body's own immune system mediate the severity of periodontitis, where teeth may become loose, fall out or have to be removed. Non-surgical sanative therapy (also referred to as "deep cleaning") is the primary treatment option for patients with generalized chronic periodontitis. This includes debridement with both ultrasonic and hand instrumentation. Using this approach, surgery is avoided for 93% of patients who undergo sanative therapy at our private periodontal specialty practice (unpublished data). However, the hand-held instrumentation requires continuous sharpening for optimal performance, which introduces tremendous variability as well as a large increase in time spent by the hygienists. Ultrasonic instrumentation does not require sharpening, as a new instrument head is used for every new patient.
Therefore, given the interest in "contemporary instrumentation", meaning ultrasonic therapy alone, the primary objective of this study is to determine if similar improvements in periodontal indices can be achieved using ultrasonic instrumentation alone versus ultrasonic instrumentation in conjunction with hand instrumentation.
Secondary objectives included the following: i) to determine if the time required to complete sanative therapy is reduced using ultrasonic therapy alone, given the ultrasonic instruments do not require sharpening and less instrument changes by the hygienist are required during treatment. If the time is less for ultrasonic therapy alone, there is a potential cost-savings for the patient, as well as less time spent receiving therapy in the dental chair; ii) to determine if the treatment with ultrasonic therapy versus ultrasonic therapy and hand instrumentation is more comfortable for the patient; and iii) to determine if there is less sensitivity to the teeth with ultrasonic therapy alone compared to the combination of ultrasonic therapy and hand instrumentation.
- Conditions
- Periodontitis, Periodontal Pocket
- Being tested
- Ultrasonic alone, Ultrasonic+
- Keywords
- Sanative Therapy, Ultrasonic Therapy, Deep Scaling, Hand Scaling
- Medical subject headings
- Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic aloneDevice
Sanative therapy using ultrasonic instrumentation alone
Ultrasonic+Device
Sanative therapy using ultrasonic plus hand instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic alone | Experimental | Sanative therapy using ultrasonic instrumentation only. Receives: Device: Ultrasonic alone |
| Ultrasonic+ | Active comparator | Sanative therapy using ultrasonic plus hand instrumentation. Receives: Device: Ultrasonic+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal healing evaluated based on changes in mean probing depth (mm)
Healing is evaluated based on changes in mean probing depth
Measured: Baseline and between 8 and 12 weeks after sanative therapy
Secondary outcomes (3)
Plaque index
O'Leary Plaque Score Index is a score in the total amount of plaque present at 4 surfaces of a tooth
Measured: Baseline and between 8 and 12 weeks after sanative therapy
Bleeding on Probing
Inflammation is determined by percent of bleeding sites that are measured at 6 sites per tooth
Measured: Baseline and between 8 and 12 weeks after sanative therapy
Clinical Attachment Loss (Periodontal Attachment Loss)
Periodontal healing is evaluated based on changes in clinical attachment loss
Measured: Baseline and between 8 and 12 weeks after sanative therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 May 2017
- Primary completion5 Feb 2019
- Study completion5 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized to receive one of two treatment modalities on either the left or right side of the mouth on their first treatment visit. During the second treatment visit, subjects will receive the other treatment modality on the other side of the mouth.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
- Responsible party
- Principal investigator, Wendy E. Ward, Ph.D., Brock University
- Investigators
- Peter C Fritz, D.D.S., Study director, Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074565
- Sponsor's protocol ID
- 16-224
- Status last verified
- Jul 2019
- First submitted
- 1 Mar 2017
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasonic Versus Hand Instrumentation Plus Ultrasonic for Effective Sanative Therapy
- ClinicalTrials.gov ID
- NCT03074565
- Acronym / sponsor ID
- 16-224
- Conditions
- Periodontitis, Periodontal Pocket
- Keywords
- Sanative Therapy, Ultrasonic Therapy, Deep Scaling, Hand Scaling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
- Study start
- 1 May 2017 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 5 Feb 2019 (actual)
- First posted
- 9 Mar 2017 (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.
Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Non-surgical sanative therapy using a combination treatment of hand and ultrasonic instrumentation is the primary treatment option for patients with periodontitis. However, the hand-held instrumentation requires continuous sharpening for optimal outcomes, which introduces tremendous variability as well as a large increase in time spent by the treating dental hygienists. Therefore, this study aimed to determine if ultrasonic instrumentation alone can provide similar improvements to periodontal outcomes compared to ultrasonic plus hand instrumentation.
Detailed description
Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Bacteria and the body's own immune system mediate the severity of periodontitis, where teeth may become loose, fall out or have to be removed. Non-surgical sanative therapy (also referred to as "deep cleaning") is the primary treatment option for patients with generalized chronic periodontitis. This includes debridement with both ultrasonic and hand instrumentation. Using this approach, surgery is avoided for 93% of patients who undergo sanative therapy at our private periodontal specialty practice (unpublished data). However, the hand-held instrumentation requires continuous sharpening for optimal performance, which introduces tremendous variability as well as a large increase in time spent by the hygienists. Ultrasonic instrumentation does not require sharpening, as a new instrument head is used for every new patient.
Therefore, given the interest in "contemporary instrumentation", meaning ultrasonic therapy alone, the primary objective of this study is to determine if similar improvements in periodontal indices can be achieved using ultrasonic instrumentation alone versus ultrasonic instrumentation in conjunction with hand instrumentation.
Secondary objectives included the following: i) to determine if the time required to complete sanative therapy is reduced using ultrasonic therapy alone, given the ultrasonic instruments do not require sharpening and less instrument changes by the hygienist are required during treatment. If the time is less for ultrasonic therapy alone, there is a potential cost-savings for the patient, as well as less time spent receiving therapy in the dental chair; ii) to determine if the treatment with ultrasonic therapy versus ultrasonic therapy and hand instrumentation is more comfortable for the patient; and iii) to determine if there is less sensitivity to the teeth with ultrasonic therapy alone compared to the combination of ultrasonic therapy and hand instrumentation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to receive one of two treatment modalities on either the left or right side of the mouth on their first treatment visit. During the second treatment visit, subjects will receive the other treatment modality on the other side of the mouth.
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic alone | Experimental | Device: Ultrasonic aloneSanative therapy using ultrasonic instrumentation only. |
| Ultrasonic+ | Active comparator | Device: Ultrasonic+Sanative therapy using ultrasonic plus hand instrumentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both males and females age 19 years or older who are undergoing sanative therapy for moderate to severe chronic periodontitis are eligible.
- Chronic periodontitis has been classified as localized or generalized depending on whether <30% or >30% of sites are involved.
- Severity is based on the amount of clinical attachment loss (CAL) and is designated as slight (1-2 mm CAL), moderate (3-4 mm CAL) or severe (> 5 mm CAL).
Key exclusion criteria (4 listed)
- Patients with dental implants,
- pregnancy,
- a recent history of antibiotic use (within 3 months prior to treatment) and
- inability to give consent for the study.
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 |
|---|---|---|
| Ultrasonic aloneSanative therapy using ultrasonic instrumentation alone | Device | Ultrasonic alone |
| Ultrasonic+Sanative therapy using ultrasonic plus hand instrumentation | Device | Ultrasonic+ |
Primary outcome
Periodontal healing evaluated based on changes in mean probing depth (mm)
Time frame: Baseline and between 8 and 12 weeks after sanative therapy
Healing is evaluated based on changes in mean probing depth
3 secondary outcomes
Plaque index
Time frame: Baseline and between 8 and 12 weeks after sanative therapy
Bleeding on Probing
Time frame: Baseline and between 8 and 12 weeks after sanative therapy
Clinical Attachment Loss (Periodontal Attachment Loss)
Time frame: Baseline and between 8 and 12 weeks after sanative therapy
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 10 Jul 2019.
- 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.
Peter C Fritz, D.D.S. study director
Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic alone and Ultrasonic+ in people with Periodontitis and Periodontal Pocket, run by Brock University at 2 sites in Canada.
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 3 inclusion and 4 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Periodontal healing evaluated based on changes in mean probing depth (mm) (time frame: Baseline and between 8 and 12 weeks after sanative therapy). 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 10 Jul 2019.