InflammationMANTRANCT05178563
Mechanisms of Acute Inflammation Following Periodontal Treatment
A study testing IPT+PDT in people with Inflammation and Periodontal Diseases, run by University College, London at 1 site in United Kingdom.
Trial summary
Periodontitis (gum disease) is a chronic inflammatory disease linked to a imbalance of oral microbiome. The most usual treatment involves removal of sub and supra-gingival plaque and calculus otherwise known as Non-surgical periodontal therapy (NSPT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Periodontal Diseases
- What is being tested?
- IPT+PDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male/Female subject must be 18 years of age or over.
- Affected by periodontitis, with at least 20 sites with PPD>4mm and have at least 20 teeth (excluding wisdom teeth).
- Have voluntarily signed the informed consent.
Who cannot join
- Presence of any systemic diseases (e.g., diabetes mellitus or cardiovascular, kidney, liver or lung disease).
- Pregnant or breastfeeding.
- Regular use of analgesic or antibiotics within 1 month before entering the study.
- Have untreated gross carious lesions and/or insufficient restorations.
- Allergic to any ingredient in the products provided within the trial as determined by the dental/medical professional monitoring the study.
- Concurrent participation in other clinical studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Eastman Dental Hospital
London
Francesco D'Aiuto, PhD
Marco Orlandi, PhD
About this study
Official title: Mechanisms of Acute Inflammation Following Periodontal Treatment (STUDENT STUDY)
Periodontitis (gum disease) is a chronic inflammatory disease linked to a imbalance of oral microbiome. The most usual treatment involves removal of sub and supra-gingival plaque and calculus otherwise known as Non-surgical periodontal therapy (NSPT). Ample evidence now indicates that Periodontitis and NSPT are linked to both local and systemic inflammation. This in turn also explains the association between periodontitis and a number of systemic diseases including cardiovascular diseases.
Vascular endothelium (the innermost lining of blood vessels) exerts protective, anti-inflammatory and anti-clotting functions. As the endothelium ages, and is exposed to the damaging effects of traditional cardiovascular risk factors such as elevated blood pressure, serum cholesterol, glucose and cigarette smoking; these protective properties appear diminished, leading to a state of endothelial dysfunction (ED). Understanding the mechanisms of ED in humans could lead to new therapeutic and/or preventive strategies of CV diseases. Sufficient evidence now suggests that periodontitis and its treatment (removal of sub and supra-gingival plaque and calculus-periodontal therapy) are linked to endothelial dysfunction. Studies have extensively characterized the time-course of a single session of non surgical periodontal treatment (IPT) associated with a one week acute inflammatory response. This substantial inflammatory response is also associated with ED assessed by flow-mediated dilation (FMD) of the brachial artery at 24 hrs.
Photodynamic therapy (PDT) helps kill the local pathogens, thus preventing their systemic dissemination; which may ultimately reduce the systemic host inflammatory response generated.
Read the detailed description
Periodontitis (gum disease) is a chronic inflammatory disease linked to a imbalance of oral microbiome. The most usual treatment involves removal of sub and supra-gingival plaque and calculus otherwise known as Non-surgical periodontal therapy (NSPT). Ample evidence now indicates that Periodontitis and NSPT are linked to both local and systemic inflammation. This in turn also explains the association between periodontitis and a number of systemic diseases including cardiovascular diseases.
Vascular endothelium (the innermost lining of blood vessels) exerts protective, anti-inflammatory and anti-clotting functions. As the endothelium ages, and is exposed to the damaging effects of traditional cardiovascular risk factors such as elevated blood pressure, serum cholesterol, glucose and cigarette smoking; these protective properties appear diminished, leading to a state of endothelial dysfunction (ED). Understanding the mechanisms of ED in humans could lead to new therapeutic and/or preventive strategies of CV diseases. Sufficient evidence now suggests that periodontitis and its treatment (removal of sub and supra-gingival plaque and calculus-periodontal therapy) are linked to endothelial dysfunction. Studies have extensively characterised the time-course of a single session of intense non surgical periodontal treatment (IPT) associated with a one week acute inflammatory response. This substantial inflammatory response is also associated with ED assessed by flow-mediated dilation (FMD) of the brachial artery at 24 hrs.
The efficacy of periodontal therapy is directly related to the ability of treatment to control the infection sustained by gum bacteria. Several chemical agents, such as antiseptic/bacteriostatic liquids, gels or membranes have been added to the conventional periodontal therapy with the view of improving clinical outcomes. The latest evidence advocates the use of lasers to eliminate bacteria in the periodontal pockets. Photodynamic therapy (PDT) is the process of eradication of target cells by reactive oxygen compound produced after activation of a photo-sensitiser by light of appropriate wavelength. Dental lasers used for PDT can be high-level lasers, low-level laser, and diode lasers. PDT used in dentistry for microbial killing, usually involves the use of low-intensity diode laser irradiation along with photosensitises as a means of arresting the anti-microbial activity.
Researchers and clinicians don't fully understand the mechanism underlying the local and systemic pathways involved in the role of periodontal/oral inflammation on systemic health and diseases Based on the evidence that PDT could kill the local pathogens, thus preventing their systemic dissemination; which may ultimately reduce the systemic host inflammatory response generated. The investigators hypothesized that using PDT before NSPT would result in less local and systemic inflammation/ED Understanding the mechanisms of ED in humans could lead to new beneficial and/or preventive strategies for cardio vascular disease.
- Conditions
- Inflammation, Periodontal Diseases
- Being tested
- IPT+PDT, IPT+Placebo
- Medical subject headings
- Inflammation, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPT+PDTProcedure or surgery
The experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT).
IPT+PlaceboProcedure or surgery
IPT+Placebo
| Study group | Role | What they receive |
|---|---|---|
| IPT+PDT | Experimental | The experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT). Receives: Procedure: IPT+PDT |
| ; IPT+Placebo | Sham comparator | This experimental arm consist of performing IPT in randomly assigning patients to receive sham use of photodynamic therapy(PDT). Receives: Procedure: IPT+Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to investigate the efficacy and safety of pre-treatment with photodynamic therapy on systemic vascular dysfunction (assessed via FMD) following a single session of non-surgical periodontal therapy (IPT) vs. IPT alone.
The primary outcome -Flow-mediated dilatation (an ultra-sound scan) of the brachial artery- at 24 hours between study groups to see changes in vessel wall elasticity.
Vessel Wall Elasticity (Vascular dysfunction) will be observed in the population of periodontitis patients who will undergo IPT with or without photodynamic therapy, using Flow mediated dilatation (FMD) which is an ultra-sound scan of brachial artery (before and after treatment).
FMD measurements will be done to assess the % change in vessel wall diameter.
Measured: 24 hours post op
Secondary outcomes (11)
FMD at different time points following treatment between study groups.
FMD at 0,1, 3, 7 and 180 days following treatment between study groups. FMD measurements will be done to assess the % change in vessel wall diameter.
Measured: 0, 1, 3, 7 and 180 days following treatment.
Pulse wave velocity (PWV) at different time points following treatment between study groups.
PWV at 0,1, 3, 7 and 180 days following treatment between study groups. Pulse wave velocity (PWV) is a measure of arterial stiffness between to measurement sites . PWV is measured according to pulse rate detected.
Measured: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
Evaluate the effect of PDT /IPT on acute phase biomarkers of systemic inflammation (hs-CRP, Serum amyloid A (SAA).
The values for biomarkers hs-CRP and SAA-mg/L,will be expressed in mg/L
The effect will be determined by changes in units of measurement for each blood marker as applicable.
Measured: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
Evaluate the effect of PDT /IPT on cellular adhesion molecule biomarkers of systemic inflammation comprising of (ICAM-1, VCAM-1)
The values forICAM-1 and VCAM-1 will be expressed in ng/mL
The effect will be determined by changes in units of measurement for each blood marker as applicable.
Measured: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
Evaluate the effect of PDT /IPT on cytokine biomarkers of systemic inflammation which are Interleukins (IL-6, IL-8, IL-10, IL-17A, IL-18, IL-23), Interferon (IFN- γ), Tumour necrosis factor (TNF-α), Monocyte chemotactic protein (MCP-1) and Thrombopoeitin (TPO)
The values for all these cytokines comprising of Interleukins(IL)- IL-6, IL-8, IL-10, IL-17A, IL-18, IL-23 will be expressed in pg/ml.
The value of IFN- γ-will be expressed in pg/ml.
The value of TNF-α will be expressed in pg/ml.
The value of MCP-1 will be expressed in pg/ml.
The value of TPO will be expressed in pg/ml.
The effect will be determined by changes in units of measurement for each cytokine blood marker which will be expressed in pg/ml for all these markers.
Measured: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
Evaluate the effect of PDT /IPT on lipid biomarkers of systemic inflammation- lipidemic markers comprising of HDL, LDL, TG.
The values for all lipidemic markers will be expressed as:
HDL-as mg/dL, LDL-mg/dL, TG- mmol/L
The effect will be determined by changes in units of measurement for each blood marker as applicable.
Measured: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on markers of endothelial function
Evaluate the effect of PDT /IPT on markers of endothelial activation (E-Selectin, ICAM-3, P-Selectin, Thrombomodulin) at different time points following treatment between study groups.
The value of these biomarkers will be expressed as E-Selectin- pg/ml, ICAM-3-ng/mL, P-Selectin- pg/ml, Thrombomodulin- pg/ml.
The effect will be determined by changes in units of measurement for each blood marker as applicable.
Measured: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on glycemic profile
Evaluate the effect of PDT /IPT on glycemic profile at different time points following treatment between study groups.
Glycemic values will be measured as blood glucose levels are measured in units called mmol/L (pronounced milli-moles-per-litre).
Measured: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on oxidative profile
Evaluate the effect of PDT /IPT on oxidative profile (d-ROMs) at different time points following treatment between study groups.
Oxidative profile (d-ROMs) will be measured in Carratelli units..
Measured: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT/IPT on the monocyte subset, monocyte platelet aggregate (MPA) , and circulating endothelial progenitor cells (EPC).
Evaluate the effect of PDT/IPT on the monocyte subset, monocyte platelet aggregate (MPA) , and circulating endothelial progenitor cells (EPC) assessed via flow cytometry in a population of patients suffering from periodontitis at different time points following treatment between study groups. The values will be determined by changes in cell count over time.
Measured: 0, 1, 3, 7 and 180 days following treatment.
Investigate the periodontal clinical parameters following IPT with and without the use of PDT.
Clinical periodontal parameters differences at following PDT+IPT or IPT. Clinical periodontal parameters will be recorded by a single calibrated examiner using a manual University of North Carolina (UNC-15) periodontal probe to see level of gingival margin with reference to a fixed point on the tooth (cementoenamel junction(CEJ)). The measurements will be recorded in millimetres.
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Sep 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178563
- Sponsor's protocol ID
- IRAS Project number 279840
- Acronym
- MANTRA
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Acute Inflammation Following Periodontal Treatment (STUDENT STUDY)
- ClinicalTrials.gov ID
- NCT05178563
- Acronym / sponsor ID
- MANTRA / IRAS Project number 279840
- Conditions
- Inflammation, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Periodontitis (gum disease) is a chronic inflammatory disease linked to a imbalance of oral microbiome. The most usual treatment involves removal of sub and supra-gingival plaque and calculus otherwise known as Non-surgical periodontal therapy (NSPT). Ample evidence now indicates that Periodontitis and NSPT are linked to both local and systemic inflammation. This in turn also explains the association between periodontitis and a number of systemic diseases including cardiovascular diseases.
Vascular endothelium (the innermost lining of blood vessels) exerts protective, anti-inflammatory and anti-clotting functions. As the endothelium ages, and is exposed to the damaging effects of traditional cardiovascular risk factors such as elevated blood pressure, serum cholesterol, glucose and cigarette smoking; these protective properties appear diminished, leading to a state of endothelial dysfunction (ED). Understanding the mechanisms of ED in humans could lead to new therapeutic and/or preventive strategies of CV diseases. Sufficient evidence now suggests that periodontitis and its treatment (removal of sub and supra-gingival plaque and calculus-periodontal therapy) are linked to endothelial dysfunction. Studies have extensively characterized the time-course of a single session of non surgical periodontal treatment (IPT) associated with a one week acute inflammatory response. This substantial inflammatory response is also associated with ED assessed by flow-mediated dilation (FMD) of the brachial artery at 24 hrs.
Photodynamic therapy (PDT) helps kill the local pathogens, thus preventing their systemic dissemination; which may ultimately reduce the systemic host inflammatory response generated.
Detailed description
Periodontitis (gum disease) is a chronic inflammatory disease linked to a imbalance of oral microbiome. The most usual treatment involves removal of sub and supra-gingival plaque and calculus otherwise known as Non-surgical periodontal therapy (NSPT). Ample evidence now indicates that Periodontitis and NSPT are linked to both local and systemic inflammation. This in turn also explains the association between periodontitis and a number of systemic diseases including cardiovascular diseases.
Vascular endothelium (the innermost lining of blood vessels) exerts protective, anti-inflammatory and anti-clotting functions. As the endothelium ages, and is exposed to the damaging effects of traditional cardiovascular risk factors such as elevated blood pressure, serum cholesterol, glucose and cigarette smoking; these protective properties appear diminished, leading to a state of endothelial dysfunction (ED). Understanding the mechanisms of ED in humans could lead to new therapeutic and/or preventive strategies of CV diseases. Sufficient evidence now suggests that periodontitis and its treatment (removal of sub and supra-gingival plaque and calculus-periodontal therapy) are linked to endothelial dysfunction. Studies have extensively characterised the time-course of a single session of intense non surgical periodontal treatment (IPT) associated with a one week acute inflammatory response. This substantial inflammatory response is also associated with ED assessed by flow-mediated dilation (FMD) of the brachial artery at 24 hrs.
The efficacy of periodontal therapy is directly related to the ability of treatment to control the infection sustained by gum bacteria. Several chemical agents, such as antiseptic/bacteriostatic liquids, gels or membranes have been added to the conventional periodontal therapy with the view of improving clinical outcomes. The latest evidence advocates the use of lasers to eliminate bacteria in the periodontal pockets. Photodynamic therapy (PDT) is the process of eradication of target cells by reactive oxygen compound produced after activation of a photo-sensitiser by light of appropriate wavelength. Dental lasers used for PDT can be high-level lasers, low-level laser, and diode lasers. PDT used in dentistry for microbial killing, usually involves the use of low-intensity diode laser irradiation along with photosensitises as a means of arresting the anti-microbial activity.
Researchers and clinicians don't fully understand the mechanism underlying the local and systemic pathways involved in the role of periodontal/oral inflammation on systemic health and diseases Based on the evidence that PDT could kill the local pathogens, thus preventing their systemic dissemination; which may ultimately reduce the systemic host inflammatory response generated. The investigators hypothesized that using PDT before NSPT would result in less local and systemic inflammation/ED Understanding the mechanisms of ED in humans could lead to new beneficial and/or preventive strategies for cardio vascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPT+PDT | Experimental | Procedure: IPT+PDTThe experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT). |
| ; IPT+Placebo | Sham comparator | Procedure: IPT+PlaceboThis experimental arm consist of performing IPT in randomly assigning patients to receive sham use of photodynamic therapy(PDT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male/Female subject must be 18 years of age or over.
- Affected by periodontitis, with at least 20 sites with PPD>4mm and have at least 20 teeth (excluding wisdom teeth).
- Have voluntarily signed the informed consent.
Key exclusion criteria (6 listed)
- Presence of any systemic diseases (e.g., diabetes mellitus or cardiovascular, kidney, liver or lung disease).
- Pregnant or breastfeeding.
- Regular use of analgesic or antibiotics within 1 month before entering the study.
- Have untreated gross carious lesions and/or insufficient restorations.
- Allergic to any ingredient in the products provided within the trial as determined by the dental/medical professional monitoring 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 |
|---|---|---|
| IPT+PDTThe experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT). | Procedure or surgery | IPT+PDT |
| IPT+PlaceboIPT+Placebo | Procedure or surgery | ; IPT+Placebo |
Primary outcome
The primary objective is to investigate the efficacy and safety of pre-treatment with photodynamic therapy on systemic vascular dysfunction (assessed via FMD) following a single session of non-surgical periodontal therapy (IPT) vs. IPT alone.
Time frame: 24 hours post op
The primary outcome -Flow-mediated dilatation (an ultra-sound scan) of the brachial artery- at 24 hours between study groups to see changes in vessel wall elasticity. Vessel Wall Elasticity (Vascular dysfunction) will be observed in the population of periodontitis patients who will undergo IPT with or without photodynamic therapy, using Flow mediated dilatation (FMD) which is an ultra-sound scan of brachial artery (before and after treatment). FMD measurements will be done to assess the % change in vessel wall diameter.
11 secondary outcomes
FMD at different time points following treatment between study groups.
Time frame: 0, 1, 3, 7 and 180 days following treatment.
Pulse wave velocity (PWV) at different time points following treatment between study groups.
Time frame: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
Time frame: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
Time frame: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
Time frame: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation.
Time frame: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on markers of endothelial function
Time frame: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on glycemic profile
Time frame: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT /IPT on oxidative profile
Time frame: 0, 1, 3, 7 and 180 days following treatment.
Evaluate the effect of PDT/IPT on the monocyte subset, monocyte platelet aggregate (MPA) , and circulating endothelial progenitor cells (EPC).
Time frame: 0, 1, 3, 7 and 180 days following treatment.
Investigate the periodontal clinical parameters following IPT with and without the use of PDT.
Time frame: 6 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPT+PDT in people with Inflammation and Periodontal Diseases, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Nov 2023. 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 Kingdom. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The primary objective is to investigate the efficacy and safety of pre-treatment with photodynamic therapy on systemic vascular dysfunction (assessed via FMD) following a single session of non-surgical periodontal therapy (IPT) vs. IPT alone. (time frame: 24 hours post op). 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 29 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.