DENT IMPLANTSPhase 4NCT04187053
Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation
A Phase 4 study testing Conventional mechanical therapy, Saline and Methylene Blue in people with DENT IMPLANTS and LASER, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare clinical outcomes (change in bleeding sites (BOP) and probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic therapy (aPDT) and assess the microbiologic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DENT IMPLANTS, LASER
- What is being tested?
- Conventional mechanical therapy, Saline and Methylene Blue
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2020to 6 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- at least one implant with peri-implant inflammation that requires non-surgical treatment.
- Peri-implant diseases included are peri-implant mucositis and peri-implantitis
- Criteria for diagnosis of peri-implant mucositis or peri-implantitis:
- Red, swollen gingival tissues surrounding the implant
- Presence of bleeding and/or suppuration on gentle probing around the implant
- Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth)
- May or may not have progressive bone loss in relation to radiographic bone levels assessed either 1 year following restoration of the implant OR ≥3mm of radiographic bone loss from the implant platform -systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.
Who cannot join
- current heavy smokers (>10 cigarettes/day)
- have diabetes or other systemic diseases that may comprise healing
- take antibiotics within 3 months before the procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston School of Dentistry
Houston, Texas, 77030
About this study
Official title: Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical Treatment of Peri-implant Disease
The purpose of this study is to compare clinical outcomes (change in bleeding sites (BOP) and probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic therapy (aPDT) and assess the microbiologic profile of plaque samples before and after treatment with or without aPDT samples.
- Conditions
- DENT IMPLANTS, LASER
- Being tested
- Conventional mechanical therapy, Saline, Methylene Blue, Light emitting laser, Non-light emitting laser
- Keywords
- Dental implants, Laser, Antimicrobial photodynamic therapy, Low level laser therapy, Peri-implant mucositis, Peri-implantitis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional mechanical therapyProcedure or surgery
Both experimental and sham arms will receive the Conventional mechanical therapy
SalineDrug
Sham group will receive saline as a sham for methylene blue
Methylene BlueDrug
Experimental arm will receive methylene blue
Light emitting laserDevice
Experimental arm will receive Light emitting laser
Non-light emitting laserDevice
Sham group will receive Non-light emitting laser
| Study group | Role | What they receive |
|---|---|---|
| Conventional mechanical therapy with aPDT adjunct | Experimental | Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline. Receives: Procedure: Conventional mechanical therapy; Drug: Methylene Blue; Device: Light emitting laser |
| Conventional mechanical therapy with sham aPDT treatment | Sham comparator | Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser Receives: Procedure: Conventional mechanical therapy; Drug: Saline; Device: Non-light emitting laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Probing Pocket Depth
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.
Measured: Baseline
Mean Probing Pocket Depth
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.
Measured: 6 weeks post treatment
Mean Probing Pocket Depth
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.
Measured: 12 weeks post treatment
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Measured: Baseline
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Measured: 6 weeks post treatment
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Measured: 12 weeks post treatment
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.
Measured: Baseline
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.
Measured: 6 weeks post treatment
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.
Measured: 12 weeks post treatment
Number of Sites With Plaque Per Participant
Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.
Measured: Baseline
Number of Sites With Plaque Per Participant
Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.
Measured: 6 weeks post treatment
Number of Sites With Plaque Per Participant
Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.
Measured: 12 weeks post treatment
Max Probing Pocket Depth
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.
Measured: Baseline
Max Probing Pocket Depth
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.
Measured: 6 weeks post treatment
Max Probing Pocket Depth
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.
Measured: 12 weeks post treatment
Secondary outcomes (4)
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
Plaque samples will be taken from the deepest probing site of each implant at baseline and 12 weeks after aPDT. To assess bacteria in the sample, the V4 region of the 16S rRNA gene will be PCR amplified and sequenced, and 16S rRNA gene data will then be analyzed to determine the alpha diversity of the microbiota community at the implant site. In this study, the minimum alpha diversity is 1 and the maximum is 2501. A higher alpha diversity indicates a higher number of bacterial or taxonomic "units" in the sample.
Measured: Baseline
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
Plaque samples will be taken from the deepest probing site of each implant at baseline and 12 weeks after aPDT. To assess bacteria in the sample, the V4 region of the 16S rRNA gene will be PCR amplified and sequenced, and 16S rRNA gene data will then be analyzed to determine the alpha diversity of the microbiota community at the implant site. In this study, the minimum alpha diversity is 1 and the maximum is 2501. A higher alpha diversity indicates a higher number of bacterial or taxonomic "units" in the sample.
Measured: 12 weeks post treatment
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
PISF samples will be taken from six sites of each implant at baseline and 12 weeks after aPDT. The levels of interleukin IL-1a, IL-1b, IL-6, IL-8, IL-10, IL-12, IL-7A, tumor necrosis factor (TNF)-a, C-reactive protein, osteoprotegerin, leptin, and adiponectin will be determined using multiplex proteomic immunoassays.
Measured: Baseline
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
PISF samples will be taken from six sites of each implant at baseline and 12 weeks after aPDT. The levels of interleukin IL-1a, IL-1b, IL-6, IL-8, IL-10, IL-12, IL-7A, tumor necrosis factor (TNF)-a, C-reactive protein, osteoprotegerin, leptin, and adiponectin will be determined using multiplex proteomic immunoassays.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start14 Feb 2020
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DENT IMPLANTSStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Laser Dentistry
- Responsible party
- Principal investigator, Jiayin Tan, The University of Texas Health Science Center, Houston
- Investigators
- Jiayin Tan, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187053
- Sponsor's protocol ID
- HSC-DB-19-0873
- Status last verified
- Jan 2024
- First submitted
- 26 Nov 2019
- Last updated
- 21 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical Treatment of Peri-implant Disease
- ClinicalTrials.gov ID
- NCT04187053
- Acronym / sponsor ID
- HSC-DB-19-0873
- Conditions
- DENT IMPLANTS, LASER
- Keywords
- Dental implants, Laser, Antimicrobial photodynamic therapy, Low level laser therapy, Peri-implant mucositis, Peri-implantitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Academy of Laser Dentistry
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Posted 29 Dec 2023
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 compare clinical outcomes (change in bleeding sites (BOP) and probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic therapy (aPDT) and assess the microbiologic profile of plaque samples before and after treatment with or without aPDT samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional mechanical therapy with aPDT adjunct | Experimental | Procedure: Conventional mechanical therapy, Drug: Methylene Blue, Device: Light emitting laserTraditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline. |
| Conventional mechanical therapy with sham aPDT treatment | Sham comparator | Procedure: Conventional mechanical therapy, Drug: Saline, Device: Non-light emitting laserControl group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- at least one implant with peri-implant inflammation that requires non-surgical treatment.
- Peri-implant diseases included are peri-implant mucositis and peri-implantitis
- Red, swollen gingival tissues surrounding the implant
- Presence of bleeding and/or suppuration on gentle probing around the implant
- Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth)
Key exclusion criteria (3 listed)
- current heavy smokers (>10 cigarettes/day)
- have diabetes or other systemic diseases that may comprise healing
- take antibiotics within 3 months before the procedure
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 |
|---|---|---|
| Conventional mechanical therapyBoth experimental and sham arms will receive the Conventional mechanical therapy | Procedure or surgery | Conventional mechanical therapy with aPDT adjunct, Conventional mechanical therapy with sham aPDT treatment |
| SalineSham group will receive saline as a sham for methylene blue | Drug | Conventional mechanical therapy with sham aPDT treatment |
| Methylene BlueExperimental arm will receive methylene blue | Drug | Conventional mechanical therapy with aPDT adjunct |
| Light emitting laserExperimental arm will receive Light emitting laser | Device | Conventional mechanical therapy with aPDT adjunct |
| Non-light emitting laserSham group will receive Non-light emitting laser | Device | Conventional mechanical therapy with sham aPDT treatment |
Primary outcome
Mean Probing Pocket Depth
Time frame: Baseline
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.
Mean Probing Pocket Depth
Time frame: 6 weeks post treatment
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.
Mean Probing Pocket Depth
Time frame: 12 weeks post treatment
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Time frame: Baseline
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Time frame: 6 weeks post treatment
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Time frame: 12 weeks post treatment
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
Time frame: Baseline
Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
Time frame: 6 weeks post treatment
Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
Time frame: 12 weeks post treatment
Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.
Number of Sites With Plaque Per Participant
Time frame: Baseline
Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.
Number of Sites With Plaque Per Participant
Time frame: 6 weeks post treatment
Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.
Number of Sites With Plaque Per Participant
Time frame: 12 weeks post treatment
Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.
Max Probing Pocket Depth
Time frame: Baseline
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.
Max Probing Pocket Depth
Time frame: 6 weeks post treatment
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.
Max Probing Pocket Depth
Time frame: 12 weeks post treatment
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.
4 secondary outcomes
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
Time frame: Baseline
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
Time frame: 12 weeks post treatment
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
Time frame: Baseline
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jiayin Tan, DDS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional mechanical therapy, Saline and Methylene Blue in people with DENT IMPLANTS and LASER, run by The University of Texas Health Science Center, Houston 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 3 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 21 Feb 2024. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Probing Pocket Depth (time frame: Baseline). The study lists 15 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 21 Feb 2024.