Chronic PeriodontitisNCT01808703
Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis
A study testing PeriZone PerioPatch and Scaling and root planing alone in people with Chronic Periodontitis, run by MIS Implant Technologies, Ltd at 2 sites in United States.
Trial summary
The purpose of this study is to determine if a topical, adhesive patch (PeriZone PerioPatch) applied to the gums after a deep tooth cleaning (scaling and root planing) reduces the signs of advanced gum disease (chronic periodontitis) more than the deep tooth cleaning alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- PeriZone PerioPatch and Scaling and root planing alone
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Sep 2013
- 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
- Adult males or females 18 years or older
- Able and willing to follow study procedures and instructions
- Must have read, understood and signed an informed consent form
- Present with at least 12 teeth in the functional dentition, excluding third molars
- Generalized, moderate to severe chronic periodontitis
- Present with at least two periodontal pockets (on separate teeth) measuring 6 mm or more and that bleed on probing
Who cannot join
- Gross oral pathology
- Chronic treatment (i.e., two weeks or more) with anti-inflammatory medications (steroids or nonsteroidal anti-inflammatory drugs) or any other medications known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporine and coumadin) within one month of the screening examination
- Antibiotic treatment within 3 month prior to the screening examination
- History of rheumatic fever, valvular disease, valve replacement or prosthetic joint replacement necessitating antibiotic prophylaxis
- Active infectious diseases such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
- Reported allergies to herbal products
Show all 10Show fewer
- Taking herbal product supplements
- Severe unrestored caries or any condition that is likely to require antibiotic treatment over the study
- Periodontal therapy (quadrant or maintenance scaling and root planing and/or periodontal surgical therapy) within 6 months prior to enrollment.
- Female patients who report being pregnant or lactating, or female patients who are of childbearing potential and who are not using hormonal, barrier methods of birth control (e.g., oral or parenteral contraceptives, diaphragm plus spermicide, condoms), or abstinence
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
School of Dentistry, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7450
Wendy Lamm, BS, 919-537-3418, wendy_lamm@dentistry.unc.edu
Rebecca S Wilder, MS
- Recruiting
G. W. Hirschfeld School of Dental Hygiene, Old Dominion University
Norfolk, Virginia, 23529
Gayle B McCombs, MS, 757-683-5150, gmccombs@odu.edu
Gayle B McCombs, MS
About this study
The purpose of this study is to determine if a topical, adhesive patch (PeriZone PerioPatch) applied to the gums after a deep tooth cleaning (scaling and root planing) reduces the signs of advanced gum disease (chronic periodontitis) more than the deep tooth cleaning alone. Eighty patients with advanced gum disease will be recruited and treated within this clinical trial. Patients will be evaluated for changes in gum measurements over a 12-week period.
Read the detailed description
Objectives: 1) to evaluate the efficacy of PeriZone PerioPatch (FDA approved device, 510K number K103054) in reducing pocket depth (PD) in subjects with moderate to severe chronic periodontitis; and 2) to assess the effect of PeriZone PerioPatch on secondary clinical outcomes associated with chronic periodontitis including bleeding on probing (BOP), clinical attachment level (CAL), Gingival Index (GI) and Plaque Index (PI).
Participants: A total of 80 participants with generalized moderate to severe chronic periodontitis will be recruited for this clinical trial.
Trial Design: This study is a multicenter, randomized, single blind, and controlled design trial with two parallel arms. The 2 arms of the study are:
- Arm A - Scaling and root planing plus PeriZone PerioPatch;
- Arm B - Scaling and root planing alone (control group).
Procedures (methods): After potential patients have been screened, informed consent forms are signed, and patients have completed the remaining screening evaluations, each patient will be randomized to a treatment group. Patients must present with generalized, moderate to severe chronic periodontitis defined as having at least two periodontal pockets measuring 6 mm or more and bleeding on probing (at Baseline).
Periodontal probing measurements (PD, CAL, GI and PI) will be performed at Baseline (prior to randomization), and at Weeks 4, 8 and 12. All subjects will receive scaling and root planing (full mouth during at most 2 sessions within two weeks following the Baseline exam). Thereafter, PeriZone PerioPatch will be dispensed to subjects per randomization for administration over the trial period (i.e., Days 1-6; Days 14-20; Days 28-30; Days 42-44). Intraoral soft tissue inspection will be performed at Screening, Baseline and at Weeks 4, 8 and 12. Adverse event collection will be performed at Weeks 4, 8 and 12. Compliance will be will be evaluated via collection of unused study devices.
Analysis Plan: Baseline and demographic data will be summarized by treatment. Adverse events and safety outcomes will be categorized by treatment and summarized with descriptive statistics. Changes in probing depths, bleeding scores, clinical attachment levels Gingival Index and Plaque Index scores (from Baseline) will be expressed as means per subjects and tested for inter-group differences using nonparametric rank analysis of covariance.
- Conditions
- Chronic Periodontitis
- Being tested
- PeriZone PerioPatch, Scaling and root planing alone
- Keywords
- Periodontitis, Periodontal pocket, Periodontal diseases
- Medical subject headings
- Chronic Periodontitis, Periodontitis, Periodontal Pocket, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeriZone PerioPatchDevice
The PeriZone PerioPatch is an approved barrier or device product intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa (510K number K103054). PerioPatch devices will be applied adjunctively following scaling and root planing).
Scaling and root planing aloneProcedure or surgery
Following completion of the Baseline examination, all randomized patients will receive full mouth scaling and root planing at a maximum of two visits within a 14-day time period (Weeks -2 to 0). Use of hand curettes and/or ultrasonic instruments will be permitted. Local or topical anesthesia may be used for patient comfort at the discretion of the clinician performing the scaling and root planing.
| Study group | Role | What they receive |
|---|---|---|
| Scaling and root planing plus PerioPatch | Experimental | All subjects in this group will receive scaling and root planing (full mouth during no more than 2 sessions within two weeks following the Baseline exam). Thereafter, PeriZone PerioPatch will be dispensed to subjects per randomization for administration over the trial period. Subjects will apply study patches (i.e., BID on Days 1, 28 and 42; QD on Days 2-6; Days 14-20, 29-30 and 43-44) to designated "treatment sites" (i.e., measuring 6 mm or more in pocket depth at Baseline). Receives: Device: PeriZone PerioPatch; Procedure: Scaling and root planing alone |
| Scaling and root planing alone | Active comparator | Subjects in this group will receive only scaling and root planing (full mouth during no more than 2 sessions within two weeks following the Baseline exam). Receives: Procedure: Scaling and root planing alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pocket depth (PD)from Baseline
PD will be measured from the free gingival margin to the base of the pocket and will be recorded in whole millimeters (mm). If a PD reading falls between two millimeter readings, the rule shall be to round down and the lower of the two readings will be recorded. All sites with PD of 5 mm or more will have two PD readings recorded (multiple-pass probing measurements) per examination time point. The average of the two PD readings will be the basis for deciding whether the site qualifies for treatment (average of two PD readings of 6 mm or more) at Baseline and the response to treatment (Weeks 4, 8 and 12).
Measured: At 4, 8 and 12 weeks
Secondary outcomes (4)
Change in clinical attachment level (CAL) from Baseline
CAL will be measured as the linear distance from the cemento-enamel junction (CEJ) to base of the pocket in mm. The examining clinician will measure CAL directly or indirectly (PD - recession). If a CAL reading falls between two millimeter readings, the rule shall be to round down and the lower of the two readings will be recorded.
Measured: At 4, 8 and 12 weeks
Change in percent bleeding on probing (BOP) from Baseline
Presence or absence of bleeding to manual probing recorded as a dichotomous variable as follows: 0 - No bleeding within 10 seconds after probing; 1 -Bleeding within 10 seconds after probing.
Measured: At 4, 8 and 12 weeks
Change in Gingival Index (GI) from Baseline
Degree of gingival inflammation recorded on an ordinal scale of 0-3 as follows (Loe \& Silness, 1963): 0- Normal gingiva; 1 - Mild inflammation (slight change in color, slight edema); no bleeding on palpation (i.e., sulcular sweep); 2 - Moderate inflammation (redness, edema, glazing); bleeding on palpation (i.e., sulcular sweep); 3 - Severe inflammation (i.e., marked redness, edema); ulceration, tendency to spontaneous bleeding.
Measured: At 4, 8 and 12 weeks
Change in Plaque Index (PI) from Baseline
Relative amount of supragingival plaque recorded on an ordinal scale of 0-3 as follows (Silness \& Loe, 1964: 0 - No plaque in the gingival area; 1 - A film of plaque adhering to the free gingival margin and the adjacent tooth. The plaque may be recognized only by running a probe across the tooth surface; 2 - Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye; 3 - Abundance of soft matter within the gingival pocket and/or on the gingival margin and the adjacent tooth surface.
Measured: At 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MIS Implant Technologies, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca S Wilder, MS, Principal investigator, University of North Carolina, Chapel HillGayle B McCombs, MS, Principal investigator, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808703
- Sponsor's protocol ID
- PZ12-02
- Other IDs
- MIS Implant Technologies Ltd.
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2013
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT01808703
- Acronym / sponsor ID
- PZ12-02
- Conditions
- Chronic Periodontitis
- Keywords
- Periodontitis, Periodontal pocket, Periodontal diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- MIS Implant Technologies, LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 11 Mar 2013 (estimated)
- 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 is to determine if a topical, adhesive patch (PeriZone PerioPatch) applied to the gums after a deep tooth cleaning (scaling and root planing) reduces the signs of advanced gum disease (chronic periodontitis) more than the deep tooth cleaning alone. Eighty patients with advanced gum disease will be recruited and treated within this clinical trial. Patients will be evaluated for changes in gum measurements over a 12-week period.
Detailed description
Objectives: 1) to evaluate the efficacy of PeriZone PerioPatch (FDA approved device, 510K number K103054) in reducing pocket depth (PD) in subjects with moderate to severe chronic periodontitis; and 2) to assess the effect of PeriZone PerioPatch on secondary clinical outcomes associated with chronic periodontitis including bleeding on probing (BOP), clinical attachment level (CAL), Gingival Index (GI) and Plaque Index (PI).
Participants: A total of 80 participants with generalized moderate to severe chronic periodontitis will be recruited for this clinical trial.
Trial Design: This study is a multicenter, randomized, single blind, and controlled design trial with two parallel arms. The 2 arms of the study are:
- Arm A - Scaling and root planing plus PeriZone PerioPatch;
- Arm B - Scaling and root planing alone (control group).
Procedures (methods): After potential patients have been screened, informed consent forms are signed, and patients have completed the remaining screening evaluations, each patient will be randomized to a treatment group. Patients must present with generalized, moderate to severe chronic periodontitis defined as having at least two periodontal pockets measuring 6 mm or more and bleeding on probing (at Baseline).
Periodontal probing measurements (PD, CAL, GI and PI) will be performed at Baseline (prior to randomization), and at Weeks 4, 8 and 12. All subjects will receive scaling and root planing (full mouth during at most 2 sessions within two weeks following the Baseline exam). Thereafter, PeriZone PerioPatch will be dispensed to subjects per randomization for administration over the trial period (i.e., Days 1-6; Days 14-20; Days 28-30; Days 42-44). Intraoral soft tissue inspection will be performed at Screening, Baseline and at Weeks 4, 8 and 12. Adverse event collection will be performed at Weeks 4, 8 and 12. Compliance will be will be evaluated via collection of unused study devices.
Analysis Plan: Baseline and demographic data will be summarized by treatment. Adverse events and safety outcomes will be categorized by treatment and summarized with descriptive statistics. Changes in probing depths, bleeding scores, clinical attachment levels Gingival Index and Plaque Index scores (from Baseline) will be expressed as means per subjects and tested for inter-group differences using nonparametric rank analysis of covariance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaling and root planing plus PerioPatch | Experimental | Device: PeriZone PerioPatch, Procedure: Scaling and root planing aloneAll subjects in this group will receive scaling and root planing (full mouth during no more than 2 sessions within two weeks following the Baseline exam). Thereafter, PeriZone PerioPatch will be dispensed to subjects per randomization for administration over the trial period. Subjects will apply study patches (i.e., BID on Days 1, 28 and 42; QD on Days 2-6; Days 14-20, 29-30 and 43-44) to designated "treatment sites" (i.e., measuring 6 mm or more in pocket depth at Baseline). |
| Scaling and root planing alone | Active comparator | Procedure: Scaling and root planing aloneSubjects in this group will receive only scaling and root planing (full mouth during no more than 2 sessions within two weeks following the Baseline exam). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult males or females 18 years or older
- Able and willing to follow study procedures and instructions
- Must have read, understood and signed an informed consent form
- Present with at least 12 teeth in the functional dentition, excluding third molars
- Generalized, moderate to severe chronic periodontitis
Key exclusion criteria (10 listed)
- Gross oral pathology
- Chronic treatment (i.e., two weeks or more) with anti-inflammatory medications (steroids or nonsteroidal anti-inflammatory drugs) or any other medications known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporine and coumadin) within one month of the screening examination
- Antibiotic treatment within 3 month prior to the screening examination
- History of rheumatic fever, valvular disease, valve replacement or prosthetic joint replacement necessitating antibiotic prophylaxis
- Active infectious diseases such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
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 |
|---|---|---|
| PeriZone PerioPatchThe PeriZone PerioPatch is an approved barrier or device product intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa (510K number K103054). PerioPatch devices will be applied adjunctively following scaling and root planing). | Device | Scaling and root planing plus PerioPatch |
| Scaling and root planing aloneFollowing completion of the Baseline examination, all randomized patients will receive full mouth scaling and root planing at a maximum of two visits within a 14-day time period (Weeks -2 to 0). Use of hand curettes and/or ultrasonic instruments will be permitted. Local or topical anesthesia may be used for patient comfort at the discretion of the clinician performing the scaling and root planing. | Procedure or surgery | Scaling and root planing alone, Scaling and root planing plus PerioPatch |
Primary outcome
Change in pocket depth (PD)from Baseline
Time frame: At 4, 8 and 12 weeks
PD will be measured from the free gingival margin to the base of the pocket and will be recorded in whole millimeters (mm). If a PD reading falls between two millimeter readings, the rule shall be to round down and the lower of the two readings will be recorded. All sites with PD of 5 mm or more will have two PD readings recorded (multiple-pass probing measurements) per examination time point. The average of the two PD readings will be the basis for deciding whether the site qualifies for treatment (average of two PD readings of 6 mm or more) at Baseline and the response to treatment (Weeks 4, 8 and 12).
4 secondary outcomes
Change in clinical attachment level (CAL) from Baseline
Time frame: At 4, 8 and 12 weeks
Change in percent bleeding on probing (BOP) from Baseline
Time frame: At 4, 8 and 12 weeks
Change in Gingival Index (GI) from Baseline
Time frame: At 4, 8 and 12 weeks
Change in Plaque Index (PI) from Baseline
Time frame: At 4, 8 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
Related trials for Chronic Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
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.
Rebecca S Wilder, MS principal investigator
University of North Carolina, Chapel Hill
Gayle B McCombs, MS principal investigator
Old Dominion University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeriZone PerioPatch and Scaling and root planing alone in people with Chronic Periodontitis, run by MIS Implant Technologies, Ltd at 2 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Mar 2013. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David W Paquette, DMD, DMSc ((631) 624-5937, david.paquette@stonybrook.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pocket depth (PD)from Baseline (time frame: At 4, 8 and 12 weeks). 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 11 Mar 2013.