PeriodontitisPhase 2NCT04093895
Trial to Evaluate Safety, Tolerability, Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis
A Phase 2 study testing PerioSept(r) in people with Periodontitis, run by Geistlich Pharma AG at 1 site in United States.
Trial summary
A Phase 2, uncontrolled, open-label, single arm study to evaluate the safety, tolerability and efficacy of PerioSept® (3%) as adjunct to Scaling and Root Planing in subjects with periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- PerioSept(r)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2019to 25 Sep 2020
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects male or female 18 to 80 years of age, inclusive.
- Subjects must be diagnosed with moderate to severe generalized periodontitis (ADA Classification Case Type III or IV) as determined by the investigator.
- Subjects must have at least 4 qualifying target teeth (having a dental pocket with PPD ≥ 6mm and BOP) (teeth having no endodontic disease - treated or untreated).
- Subjects must have at least 12 teeth in the functional dentition, excluding second and third molars In subjects with limited dentition, tooth loss should not be due to traumatic occlusion
- Females of childbearing potential must agree to use of birth control (hormonal, barrier method or abstinence). Hormonal contraceptives must have started not fewer than 30-days before baseline visit/Day 1.
- Subjects must sign informed consent document(s) prior to initiation of any study-specific procedures and treatments.
- Subjects who are able and willing to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- History of and/or known risk of life-threatening anaphylactic reactions to taurolidine, any of the components in the investigational drug product.
- Presence of an acute periodontal abscess.
- Subjects with healing disorders (e.g. uncontrolled diabetes mellitus, oral cancer) that could compromise wound healing and/or preclude periodontal surgery.
- Subjects who are taking medications that compromise wound healing presenting with clinical evidence of secondary hyperplastic gingival tissue reactions (e.g. calcium channel blockers or anti-seizure medications)
- Pregnant or nursing female subjects; women of child-bearing potential must have a negative urine pregnancy test.
- Use of systemic antibiotics and, topically applied oral antibiotics and other antimicrobial agents (e.g., chlorhexidine) within 45 days prior to Day 1 or expected use during the study trial period.
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- An existing condition that may warrant use of antibiotics during the study trial period.
- Known Human Immunodeficiency Virus infection or other immunodeficiency syndrome.
- Subjects with active infectious diseases (e.g. hepatitis, HIV or tuberculosis)
- Use of agents known to affect periodontal status during the trial and/or use within 45 days prior to Day 1 e.g. immunosuppressants, nasal or oral corticosteroids, calcium channel blockers, phenytoin or anticoagulants.
- Heavy smokers/tobacco users are excluded: defined as those smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day (smokeless nicotine products are NOT excluded)
- Participation in another clinical study with an investigational agent within 90 days prior to Day 1.
- Subjects who received oral health treatments/interventions within 90 days of Day 1, which the investigator believes may interfere with the periodontal parameters to be assessed in this study (e.g., significant dental and/or gum/oral tissue work).
- SRP or periodontal surgery within 12 months prior to Day 1.
- Subject who have a medical and/or dental condition (e.g. a current clinically unstable occlusal situation) and/or use medications/supplements which the investigator believes makes him/her unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® (3%) as Adjunct to Scaling and Root Planing in Subjects With Periodontitis
A Phase 2, uncontrolled, open-label, single arm study to evaluate the safety, tolerability and efficacy of PerioSept® (3%) as adjunct to Scaling and Root Planing in subjects with periodontitis.
Read the detailed description
Open-label, uncontrolled, single arm study to evaluate PerioSept® as adjunct to Scaling and Root Planing in Subjects with moderate to severe Periodontitis.
Up to 12 adult subjects will be enrolled to obtain at least 10 evaluable subjects.
4 study visits will take place for each enrolled subject (V1-V4 within 120 days). An additional optional follow-up visit (V5) at 6 Months might be added later on. On the baseline visit at Day 1 (V2) and if needed Day 2 (V2a) patients will undergo full mouth SRP followed by administration of PerioSept® 3% gel into gingival dental pockets. Treatment of PerioSept® 3% (without SRP) will be repeated at V3.
Eligible subjects must have a minimum of 4 qualifying target teeth defined as a tooth with at least one periodontal pocket with a probing pocket depth (PPD) >= 6mm and bleeding on probing (BOP) at baseline defined as study pockets. All study pockets will be treated with SRP and PerioSept®. Additional teeth identified by investigator as needing SRP per standard of care but not meeting target teeth criteria will be defined as non-target teeth/treatment sites and may also be treated with SRP and PerioSept®.
Dental parameters will only be assessed on the target teeth and each of the 6 sites associated with these teeth (assessment sites). Thus, each eligible patient will have at least 4 Target teeth, a minimum of 4 study pockets and a minimum of 24 assessment sites (6 sites per tooth x 4 target teeth, inclusive of the 4 study pockets) that will be assessed for all study outcome measures.
Overall for all 10 evaluable patients there will be at least 40 target teeth, 40 study pockets and 240 sites for which the study outcome measures will be assessed as specified further below.
Assessments will be conducted over a 12 weeks' and optional 24 weeks' (3 and 6 months respectively) period including safety assessments, assessments of dental parameters (PPD, Clinical attachment level, BOP, recession, Plaque index, Gingival Index) and tolerability assessment.
- Conditions
- Periodontitis
- Being tested
- PerioSept(r)
- Keywords
- Periodontitis, taurolidine, PerioSept
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerioSept(r)Drug
Also called Taurolidine
Scaling and root planing followed by 3% PerioSept(r) administration
| Study group | Role | What they receive |
|---|---|---|
| SRP and 3% PerioSept(r) | Experimental | Scaling and root planing followed by 3% PerioSept® drug administration Receives: Drug: PerioSept(r) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Mean probing pocket depth (PPD) reduction (mm) of all study pockets (pockets with PPD > 6 mm and bleeding on probing (BOP) at baseline on target teeth) at subject level and across all subjects
Mean probing pocket depth (PPD) reduction (mm) of all study pockets (pockets with PPD > 6 mm and bleeding on probing (BOP) at baseline on target teeth) at subject level and across all subjects
Measured: Baseline, Week 12
Secondary outcomes (16)
Efficacy: Mean PPD reduction (mm) of all study pockets per patient
Mean PPD reduction (mm) of all study pockets per patient
Measured: Baseline, Week 4
Efficacy: Number of study pockets changing from ≥ 6 mm PPD to ≤5 mm PPD
Number of study pockets changing from ≥ 6 mm PPD to ≤5 mm PPD
Measured: Baseline; Week 4, 12
Efficacy: Change in Clinical attachment level (CAL) of all study pockets
Change in CAL of all study pockets
Measured: Baseline; Week 4, 12
Efficacy: Change in plaque index (PI) of all study pockets
Change in PI of all study pockets
Measured: Baseline; Week 4, 12
Efficacy: Change in gingival index (GI) of all study pockets
Change in GI of all study pockets
Measured: Baseline; Week 4, 12
Efficacy: Change in BOP of all study pockets
Change in BOP of all study pockets
Measured: Baseline; Week 4, 12
Efficacy: Change in recession (REC) of all study pockets
Change in REC of all study pockets
Measured: Baseline; Week 4, 12
Efficacy: Change in PPD of all 6 assessment sites on target teeth
Change in PPD of all 6 assessment sites on target teeth
Measured: Baseline; Week 4, 12
Efficacy: Change in CAL of all 6 assessment sites on target teeth
Change in CAL of all 6 assessment sites on target teeth
Measured: Baseline; Week 4, 12
Efficacy: Change in PI of all 6 assessment sites on target teeth
Change in PI of all 6 assessment sites on target teeth
Measured: Baseline; Week 4, 12
Efficacy: Change in GI of all 6 assessment sites on target teeth
Change in GI of all 6 assessment sites on target teeth
Measured: Baseline; Week 4, 12
Efficacy: Change in BOP of all 6 assessment sites on target teeth
Change in BOP of all 6 assessment sites on target teeth
Measured: Baseline; Week 4, 12
Efficacy: Change in REC of all 6 assessment sites on target teeth
Change in REC of all 6 assessment sites on target teeth
Measured: Baseline; Week 4, 12
Safety/tolerability: Assessment of treatment-emergent adverse events based on dental examination
Assessment of treatment-emergent adverse events based on dental examination
Measured: Day -45 till Month 6
Tolerability: Clinician assessment of local irritation to include assessments of redness/erythema, inflammation/swelling, blisters or erosions, suppuration and other findings at the study treatment pockets or surrounding tissue.
Clinician assessment of local irritation to include assessments of redness/erythema, inflammation/swelling, blisters or erosions, suppuration and other findings at the study treatment pockets or surrounding tissue.
Measured: Day 1, 2, 28
Tolerability: Subject reported tolerability for pain, burning/stinging, sensitivity and taste based on a numeric rating scale
Subject reported tolerability for pain, burning/stinging, sensitivity and taste based on a numeric rating scale
Measured: Day 1, 2, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start26 Aug 2019
- Primary completion10 Jun 2020
- Study completion25 Sep 2020
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm, uncontrolled, open-label
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geistlich Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael McGuire, DDS, Principal investigator, PerioHealth Clinic Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093895
- Sponsor's protocol ID
- PSPD 2
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® (3%) as Adjunct to Scaling and Root Planing in Subjects With Periodontitis
- ClinicalTrials.gov ID
- NCT04093895
- Acronym / sponsor ID
- PSPD 2
- Conditions
- Periodontitis
- Keywords
- Periodontitis, taurolidine, PerioSept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Geistlich Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 18 Sep 2019 (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.
A Phase 2, uncontrolled, open-label, single arm study to evaluate the safety, tolerability and efficacy of PerioSept® (3%) as adjunct to Scaling and Root Planing in subjects with periodontitis.
Detailed description
Open-label, uncontrolled, single arm study to evaluate PerioSept® as adjunct to Scaling and Root Planing in Subjects with moderate to severe Periodontitis.
Up to 12 adult subjects will be enrolled to obtain at least 10 evaluable subjects.
4 study visits will take place for each enrolled subject (V1-V4 within 120 days). An additional optional follow-up visit (V5) at 6 Months might be added later on. On the baseline visit at Day 1 (V2) and if needed Day 2 (V2a) patients will undergo full mouth SRP followed by administration of PerioSept® 3% gel into gingival dental pockets. Treatment of PerioSept® 3% (without SRP) will be repeated at V3.
Eligible subjects must have a minimum of 4 qualifying target teeth defined as a tooth with at least one periodontal pocket with a probing pocket depth (PPD) >= 6mm and bleeding on probing (BOP) at baseline defined as study pockets. All study pockets will be treated with SRP and PerioSept®. Additional teeth identified by investigator as needing SRP per standard of care but not meeting target teeth criteria will be defined as non-target teeth/treatment sites and may also be treated with SRP and PerioSept®.
Dental parameters will only be assessed on the target teeth and each of the 6 sites associated with these teeth (assessment sites). Thus, each eligible patient will have at least 4 Target teeth, a minimum of 4 study pockets and a minimum of 24 assessment sites (6 sites per tooth x 4 target teeth, inclusive of the 4 study pockets) that will be assessed for all study outcome measures.
Overall for all 10 evaluable patients there will be at least 40 target teeth, 40 study pockets and 240 sites for which the study outcome measures will be assessed as specified further below.
Assessments will be conducted over a 12 weeks' and optional 24 weeks' (3 and 6 months respectively) period including safety assessments, assessments of dental parameters (PPD, Clinical attachment level, BOP, recession, Plaque index, Gingival Index) and tolerability assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm, uncontrolled, open-label
| Arm | Type | Receives |
|---|---|---|
| SRP and 3% PerioSept(r) | Experimental | Drug: PerioSept(r)Scaling and root planing followed by 3% PerioSept® drug administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects male or female 18 to 80 years of age, inclusive.
- Subjects must be diagnosed with moderate to severe generalized periodontitis (ADA Classification Case Type III or IV) as determined by the investigator.
- Subjects must have at least 4 qualifying target teeth (having a dental pocket with PPD ≥ 6mm and BOP) (teeth having no endodontic disease - treated or untreated).
- Subjects must have at least 12 teeth in the functional dentition, excluding second and third molars In subjects with limited dentition, tooth loss should not be due to traumatic occlusion
- Females of childbearing potential must agree to use of birth control (hormonal, barrier method or abstinence). Hormonal contraceptives must have started not fewer than 30-days before baseline visit/Day 1.
Key exclusion criteria (15 listed)
- History of and/or known risk of life-threatening anaphylactic reactions to taurolidine, any of the components in the investigational drug product.
- Presence of an acute periodontal abscess.
- Subjects with healing disorders (e.g. uncontrolled diabetes mellitus, oral cancer) that could compromise wound healing and/or preclude periodontal surgery.
- Subjects who are taking medications that compromise wound healing presenting with clinical evidence of secondary hyperplastic gingival tissue reactions (e.g. calcium channel blockers or anti-seizure medications)
- Pregnant or nursing female subjects; women of child-bearing potential must have a negative urine pregnancy test.
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 |
|---|---|---|
| PerioSept(r)Also: TaurolidineScaling and root planing followed by 3% PerioSept(r) administration | Drug | SRP and 3% PerioSept(r) |
Primary outcome
Efficacy: Mean probing pocket depth (PPD) reduction (mm) of all study pockets (pockets with PPD > 6 mm and bleeding on probing (BOP) at baseline on target teeth) at subject level and across all subjects
Time frame: Baseline, Week 12
Mean probing pocket depth (PPD) reduction (mm) of all study pockets (pockets with PPD > 6 mm and bleeding on probing (BOP) at baseline on target teeth) at subject level and across all subjects
16 secondary outcomes
Efficacy: Mean PPD reduction (mm) of all study pockets per patient
Time frame: Baseline, Week 4
Efficacy: Number of study pockets changing from ≥ 6 mm PPD to ≤5 mm PPD
Time frame: Baseline; Week 4, 12
Efficacy: Change in Clinical attachment level (CAL) of all study pockets
Time frame: Baseline; Week 4, 12
Efficacy: Change in plaque index (PI) of all study pockets
Time frame: Baseline; Week 4, 12
Efficacy: Change in gingival index (GI) of all study pockets
Time frame: Baseline; Week 4, 12
Efficacy: Change in BOP of all study pockets
Time frame: Baseline; Week 4, 12
Efficacy: Change in recession (REC) of all study pockets
Time frame: Baseline; Week 4, 12
Efficacy: Change in PPD of all 6 assessment sites on target teeth
Time frame: Baseline; Week 4, 12
Efficacy: Change in CAL of all 6 assessment sites on target teeth
Time frame: Baseline; Week 4, 12
Efficacy: Change in PI of all 6 assessment sites on target teeth
Time frame: Baseline; Week 4, 12
Efficacy: Change in GI of all 6 assessment sites on target teeth
Time frame: Baseline; Week 4, 12
Efficacy: Change in BOP of all 6 assessment sites on target teeth
Time frame: Baseline; Week 4, 12
Efficacy: Change in REC of all 6 assessment sites on target teeth
Time frame: Baseline; Week 4, 12
Safety/tolerability: Assessment of treatment-emergent adverse events based on dental examination
Time frame: Day -45 till Month 6
Tolerability: Clinician assessment of local irritation to include assessments of redness/erythema, inflammation/swelling, blisters or erosions, suppuration and other findings at the study treatment pockets or surrounding tissue.
Time frame: Day 1, 2, 28
Tolerability: Subject reported tolerability for pain, burning/stinging, sensitivity and taste based on a numeric rating scale
Time frame: Day 1, 2, 28
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 19 Oct 2020.
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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 McGuire, DDS principal investigator
PerioHealth Clinic Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PerioSept(r) in people with Periodontitis, run by Geistlich Pharma AG 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 7 inclusion and 15 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 19 Oct 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy: Mean probing pocket depth (PPD) reduction (mm) of all study pockets (pockets with PPD > 6 mm and bleeding on probing (BOP) at baseline on target teeth) at subject level and across all subjects (time frame: Baseline, Week 12). 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 19 Oct 2020.