Periodontal DiseasesNCT03671512
Standard Root Planing vs. Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease
A study testing Periodontal Structure Repair (PSR) and Standard Root Planing in people with Periodontal Diseases, run by Periovance, Inc at 4 sites in United States.
Trial summary
This study evaluates the efficacy and safety of Periodontal Structure Repair device (PSR) compared to conventional periodontal therapy (scaling and root planing) for the treatment of periodontal pockets caused by periodontal disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Periodontal Structure Repair (PSR) and Standard Root Planing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Dec 2018to 9 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be in stable health as determined by lack of clinically significant abnormalities as assessed at screening.
- Subjects must have a minimum of 2 teeth with a pocket depth of 5 to 8 mm per quadrant in at least two quadrants of the mouth with bleeding on probing.
- Signed and dated informed consent form, meeting all criteria of current FDA regulations and approved by the assigned IRB.
- Subject must be willing and able to follow all the post treatment oral hygiene requirements.
- Subjects must be in stable systemic health.
Who cannot join
- History of allergy or sensitivity to any of the PSR paste ingredients or other products used in the PSR or Root Planing procedure.
- Subjects who demonstrate during the pre-treatment prophylaxis cleaning visit that they cannot adequately comply with post treatment dental hygiene requirements of the study.
- History or current evidence of chronic infectious disease, system disorders, organ dysfunction, cardiovascular disorders, stroke, renal or hepatic disorder, diabetes or bleeding disorders that may prevent the subject from tolerating the scaling and root planing or PSR device and procedure or any significant clinical illness within 90 days of the study start. If any doubt is present regarding the accuracy of the subject's medical history or their suitability to participate, appropriate consultation, e.g., the Chief Medical Officer of InClinca (the CRO) should be sought or the subject excluded.
- Wears braces or had any dental procedures within 2 weeks of entering the study. Any significant dental issues noted during the screening oral examination. Any ongoing clinically significant trauma or infectious diseases in the oral cavity.
- Any previous periodontal procedures including scaling and root planing within 6 months of entering the study.
- Presence of a medical condition requiring regular treatment with antibiotics or treatment with antibiotics within six months prior to entry into the study.
Show all 17Show fewer
- Presence of a medical condition requiring treatment with anticoagulant therapy or drugs, such as heparin or warfarin. Subjects prescribed ≤ 325 mg/day of aspirin should not be excluded and this treatment should not be stopped during their participation in this trial.
- History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
- Receipt of an Investigational drug as part of a research study within 30 days or 10 half-lives (whichever is longer) prior to entry into the trial.
- A clinically significant abnormality is detected in the subject's screening blood or urine samples (clinical chemistry, hematology, or urinalysis) that in the opinion of the investigator should prohibit inclusion into the trial.
- Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody at screening.
- Subject is not able to communicate well with the Investigator, to understand and comply with the requirements of the study, or to understand the written informed consent
- Subject is not suitable to participate in the study in the opinion of the Investigator
- Teeth with any furcation defects or mobility >2 will be excluded from treatment in both arms of the study.
- Medication that alters or affects healing such as chemotherapy, immune-suppressive medications within two months of study start.
- Subjects having received doses of corticosteroids in excess of 20mg per day within 2 months of study start.
- Subjects who are pregnant or planning to become pregnant during the course/duration of the clinical trial period.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama at Birmingham School of Dentistry
Birmingham, Alabama, 35294
Forsyth Institute
Cambridge, Massachusetts, 02142
University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, 27599
Stony Brook School of Dental Medicine
Stony Brook, New York, 11794-8703
About this study
Official title: A Phase III, Prospective, Randomized, Active Comparator-controlled, Parallel Group, Subject-paired Study Comparing Standard Root Planing vs. a Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease.
This study evaluates the efficacy and safety of Periodontal Structure Repair device (PSR) compared to conventional periodontal therapy (scaling and root planing) for the treatment of periodontal pockets caused by periodontal disease.
Read the detailed description
This is a multicenter, prospective, randomized, open, active comparator-controlled study with a parallel group, subject-paired design (i.e. the effect of both treatments can be observed in the same subject).
Subjects must have two quadrants of their mouth that each have at least two teeth with one or more pockets per tooth that are 5-8 mm in depth. Subjects having more than 2 quadrants will have the first 2 quadrants randomized to receive two different treatments (one quadrant root planing and one quadrant PSR procedure) from the group of available quadrants.
Investigators will assess the efficacy of the Periodontal Structure Repair device (PSR) as measured by a reduction in pocket depth.
- Conditions
- Periodontal Diseases
- Being tested
- Periodontal Structure Repair (PSR), Standard Root Planing
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Structure Repair (PSR)Device
Following local anesthesia, initial pocket preparation will be done by bur abrasion utilizing specially designed burs to plane the root surface and remove the inner lining of the pocket. Following bur abrasion, thin strips of gauze sponge are placed into the created space. After removing the gauze strips, PSR is inserted to fill the spaces beginning at the pocket bottom. The final step is placing a layer of cyanoacrylate on both the gingival margin and tooth supragingivally.
Standard Root PlaningDevice
Ultrasonics and hand instruments are used to remove any subgingival deposits on the roots. Standard instruments and standard application are used. Visual or instrument tactile inspection is used to verify the roots are hard-smooth and have been adequately cleaned.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Structure Repair (PSR) | Experimental | Periodontal pockets treated with PSR Receives: Device: Periodontal Structure Repair (PSR) |
| Standard Root Planing (SRP) | Active comparator | Periodontal pockets treated with SRP Receives: Device: Standard Root Planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periodontal pocket depth compared to standard root planing at 8 weeks
The pocket depth is measured using a Williams' periodontal probe. The probe is inserted into the pocket until resistance is met. The depth of the pocket is measured in millimeters (mm) indicated on the probe. Measure the distance from the gingival margin to the tip of the periodontal probe. Each pocket will have six measurement taken around the tooth. The pocket depth measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
Measured: 8 weeks
An acceptable safety profile at Visit Week 8 as evidenced by no clinically significant increase in the occurrence of select adverse events
The primary safety endpoints are to demonstrate an acceptable safety profile at Visit Week 8 as evidenced by no clinically significant increase in the occurrence of any of the following adverse events for the PSR-treated pockets versus the current standard of treatment for periodontal pockets (scaling and root planing):
- an increase in pocket depth ≥ 2 mm
- clinical signs and symptoms of an abscess
- pain localized to the treated teeth.
Measured: 8 weeks
Secondary outcomes (12)
Change in periodontal pocket depth compared to standard root planing at 12 and 16 weeks
The pocket depth is measured using a Williams' periodontal probe. Each pocket will have six measurements taken around the tooth at the following locations: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
Measured: 12 weeks and 16 weeks
Change in clinical attachment level compared to standard root planing at Visit Weeks 4, 8, 12 and 16
The gingival margin level measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
Measured: 4, 8, 12, 16 weeks
To evaluate the percentage of subjects who achieve 15% and 25% improvements over baseline for pocket depth reduction for PSR-treated versus root-planed teeth.
Each pocket will have six measurement taken around the tooth. The pocket depth measurements to be performed include: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal
Measured: 4, 8, 12, 16 weeks
To evaluate the percentage of subjects who achieve 15% and 25% improvements over baseline for clinical attachment level for PSR-treated versus root-planed teeth
The gingival margin level measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
Measured: 4, 8, 12, 16 weeks
Degree of inflammation following procedure
Inflammation measured the Gingival Index (Löe and Silness, 1963).
- 0 = Normal gingiva
- 1 = Mild inflammation: slight change in color, slight edema. No bleeding on probing.
- 2 = Moderate inflammation: redness, edema, and glazing. Bleeding on probing.
- 3 = Severe inflammation: marked redness and edema. Ulceration. Tendency for spontaneous bleeding.
Measured: 8 weeks
Degree of erythema following procedure
Gingival erythema - measured using the Modified Gingival Index (MGI) (Lobene et al. 1986)
- 0 = absence of inflammation;
- 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary;
- 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary;
- 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary;
- 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration.
Measured: 8 weeks
Presence or absence of bleeding on probing following procedure
Bleeding on probing will be reported by a yes/no response
Measured: 8 weeks
Degree of Pain using the Pain Quality Assessment Scale (PQAS), National Initiative on Pain Control™ (NIPC).
The scoring system will be used to grade the amount of pain felt by the subject in their mouth and jaw areas where the scaling and root planing or PSR treatment was performed.
Measured: 8 weeks
Gingival Infection: Presence of gingival infection
Presence of gingival infection will be recorded by a yes/no response in the case report form. If infection is present, the quadrant of the mouth will be recorded.
Measured: 8 weeks
Sensitivity
Subjects will be asked by the examining dental professional if they have experienced any temperature-related pain or discomfort in their teeth or gums.
Measured: 8 weeks
Tooth mobility of PSR-treated teeth versus standard root planing
Tooth mobility will be assessed using the Tooth Mobility Scale (Miller, 1985)
- Class 1: <1mm (horizontal) movement of the tooth
- Class 2: >1mm (horizontal) movement of the tooth
- Class 3: >1mm (horizontal and vertical mobility) of the tooth
Measured: 8 weeks
Safety profile of the PSR procedure versus standard root planing for management of periodontal pocket disease through Visit Week 16.
The full safety profile will be assessed by the following:
- Evaluate the adverse event (AE) safety profile of the PSR procedure versus STA for the management of periodontal pocket disease through the trial.
- Evaluate blood laboratory values at Baseline, Visit Week 12 and Visit Week 16.
- To evaluate the pocket depth effect of the PSR device and procedure versus STA over time (including 8 week, 12 week and 16 week assessments) utilizing a longitudinal analysis approach.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start6 Dec 2018
- Primary completion17 Jan 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For each subject, one quadrant will be randomized to PSR and the other quadrant will be randomized to conventional scaling and root planing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Periovance, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Fare, Study chair, Periovance, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671512
- Sponsor's protocol ID
- PSR-001
- Status last verified
- Mar 2020
- First submitted
- 11 Sep 2018
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Prospective, Randomized, Active Comparator-controlled, Parallel Group, Subject-paired Study Comparing Standard Root Planing vs. a Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease.
- ClinicalTrials.gov ID
- NCT03671512
- Acronym / sponsor ID
- PSR-001
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Periovance, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 14 Sep 2018 (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.
This study evaluates the efficacy and safety of Periodontal Structure Repair device (PSR) compared to conventional periodontal therapy (scaling and root planing) for the treatment of periodontal pockets caused by periodontal disease.
Detailed description
This is a multicenter, prospective, randomized, open, active comparator-controlled study with a parallel group, subject-paired design (i.e. the effect of both treatments can be observed in the same subject).
Subjects must have two quadrants of their mouth that each have at least two teeth with one or more pockets per tooth that are 5-8 mm in depth. Subjects having more than 2 quadrants will have the first 2 quadrants randomized to receive two different treatments (one quadrant root planing and one quadrant PSR procedure) from the group of available quadrants.
Investigators will assess the efficacy of the Periodontal Structure Repair device (PSR) as measured by a reduction in pocket depth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- For each subject, one quadrant will be randomized to PSR and the other quadrant will be randomized to conventional scaling and root planing.
| Arm | Type | Receives |
|---|---|---|
| Periodontal Structure Repair (PSR) | Experimental | Device: Periodontal Structure Repair (PSR)Periodontal pockets treated with PSR |
| Standard Root Planing (SRP) | Active comparator | Device: Standard Root PlaningPeriodontal pockets treated with SRP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be in stable health as determined by lack of clinically significant abnormalities as assessed at screening.
- Subjects must have a minimum of 2 teeth with a pocket depth of 5 to 8 mm per quadrant in at least two quadrants of the mouth with bleeding on probing.
- Signed and dated informed consent form, meeting all criteria of current FDA regulations and approved by the assigned IRB.
- Subject must be willing and able to follow all the post treatment oral hygiene requirements.
- Subjects must be in stable systemic health.
Key exclusion criteria (17 listed)
- History of allergy or sensitivity to any of the PSR paste ingredients or other products used in the PSR or Root Planing procedure.
- Subjects who demonstrate during the pre-treatment prophylaxis cleaning visit that they cannot adequately comply with post treatment dental hygiene requirements of the study.
- History or current evidence of chronic infectious disease, system disorders, organ dysfunction, cardiovascular disorders, stroke, renal or hepatic disorder, diabetes or bleeding disorders that may prevent the subject from tolerating the scaling and root planing or PSR device and procedure or any significant clinical illness within 90 days of the study start. If any doubt is present regarding the accuracy of the subject's medical history or their suitability to participate, appropriate consultation, e.g., the Chief Medical Officer of InClinca (the CRO) should be sought or the subject excluded.
- Wears braces or had any dental procedures within 2 weeks of entering the study. Any significant dental issues noted during the screening oral examination. Any ongoing clinically significant trauma or infectious diseases in the oral cavity.
- Any previous periodontal procedures including scaling and root planing within 6 months of entering 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 |
|---|---|---|
| Periodontal Structure Repair (PSR)Following local anesthesia, initial pocket preparation will be done by bur abrasion utilizing specially designed burs to plane the root surface and remove the inner lining of the pocket. Following bur abrasion, thin strips of gauze sponge are placed into the created space. After removing the gauze strips, PSR is inserted to fill the spaces beginning at the pocket bottom. The final step is placing a layer of cyanoacrylate on both the gingival margin and tooth supragingivally. | Device | Periodontal Structure Repair (PSR) |
| Standard Root PlaningUltrasonics and hand instruments are used to remove any subgingival deposits on the roots. Standard instruments and standard application are used. Visual or instrument tactile inspection is used to verify the roots are hard-smooth and have been adequately cleaned. | Device | Standard Root Planing (SRP) |
Primary outcome
Change in periodontal pocket depth compared to standard root planing at 8 weeks
Time frame: 8 weeks
The pocket depth is measured using a Williams' periodontal probe. The probe is inserted into the pocket until resistance is met. The depth of the pocket is measured in millimeters (mm) indicated on the probe. Measure the distance from the gingival margin to the tip of the periodontal probe. Each pocket will have six measurement taken around the tooth. The pocket depth measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
An acceptable safety profile at Visit Week 8 as evidenced by no clinically significant increase in the occurrence of select adverse events
Time frame: 8 weeks
The primary safety endpoints are to demonstrate an acceptable safety profile at Visit Week 8 as evidenced by no clinically significant increase in the occurrence of any of the following adverse events for the PSR-treated pockets versus the current standard of treatment for periodontal pockets (scaling and root planing): 1. an increase in pocket depth ≥ 2 mm 2. clinical signs and symptoms of an abscess 3. pain localized to the treated teeth.
12 secondary outcomes
Change in periodontal pocket depth compared to standard root planing at 12 and 16 weeks
Time frame: 12 weeks and 16 weeks
Change in clinical attachment level compared to standard root planing at Visit Weeks 4, 8, 12 and 16
Time frame: 4, 8, 12, 16 weeks
To evaluate the percentage of subjects who achieve 15% and 25% improvements over baseline for pocket depth reduction for PSR-treated versus root-planed teeth.
Time frame: 4, 8, 12, 16 weeks
To evaluate the percentage of subjects who achieve 15% and 25% improvements over baseline for clinical attachment level for PSR-treated versus root-planed teeth
Time frame: 4, 8, 12, 16 weeks
Degree of inflammation following procedure
Time frame: 8 weeks
Degree of erythema following procedure
Time frame: 8 weeks
Presence or absence of bleeding on probing following procedure
Time frame: 8 weeks
Degree of Pain using the Pain Quality Assessment Scale (PQAS), National Initiative on Pain Control™ (NIPC).
Time frame: 8 weeks
Gingival Infection: Presence of gingival infection
Time frame: 8 weeks
Sensitivity
Time frame: 8 weeks
Tooth mobility of PSR-treated teeth versus standard root planing
Time frame: 8 weeks
Safety profile of the PSR procedure versus standard root planing for management of periodontal pocket disease through Visit Week 16.
Time frame: 16 weeks
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 30 Mar 2020.
- 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.
Michael Fare study chair
Periovance, Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal Structure Repair (PSR) and Standard Root Planing in people with Periodontal Diseases, run by Periovance, Inc at 4 sites 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 5 inclusion and 17 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Change in periodontal pocket depth compared to standard root planing at 8 weeks (time frame: 8 weeks). The study lists 2 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 30 Mar 2020.