Periodontal DiseasesAIRTIMNCT07203872
Inflammation-resolution Therapy in MINST of Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial
A study testing IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwash in people with Periodontal Diseases and Periodontitis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess whether and how a mouthwash containing an ingredient that reduces inflammation in combination with a recently developed treatment is more effective at improving advanced gum disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontal Diseases, Periodontitis
- What is being tested?
- IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwash
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2025to 1 May 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70
- Diagnosis of periodontitis stage III-IV
- Presence of at least 1 deep intrabony defect (both PPD and radiographic defects >6mm)
- Full-mouth dichotomous plaque score>30%
- Willing to voluntarily sign the informed consent.
Who cannot join
- Previous periodontal treatment to the study site within 6 months
- Use of systemic antibiotics within 3 months
- Weekly regular use of non-steroidal anti-inflammatory drugs
- Contributing medical history according to the examining clinician (e.g. diabetes mellitus)
- Smoking history (current or within 5 years)
- Allergic to any ingredient present in the products used in study.
Show all 9Show fewer
- Presence of systemic diseases, which affects bone and/or connective tissue metabolism
- Concurrent participation in other clinical studies.
- Pregnant or breastfeeding.
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
Oral Clinical Research Unit (OCRU) at King's College London (KCL)
London, SE1 9RT
Luigi Nibali, Professor, 02071888801 ext. 57284, luigi.nibali@kcl.ac.uk
Luigi Nibali, Professor
About this study
Official title: Adjunctive Inflammation-resolution Therapy in Minimally-invasive Treatment of Deep Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial
The aim of this study is to assess whether and how a mouthwash containing an ingredient that reduces inflammation in combination with a recently developed treatment is more effective at improving advanced gum disease. Advanced gum disease, also called periodontitis, is an inflammation of the gums which results in decrease in bone levels supporting teeth and can result in tooth loss. Minimally invasive non-surgical treatment (MINST) is a type of deep cleaning of teeth which involves removal of plaque beneath the gum margin and reduces inflammation. In this trial we will assess the additional benefits of combining deep cleaning (MINST) with the use of a mouthwash known to have a beneficial effect on tissue healing by helping the body to 'switch off' inflammation in periodontitis. Participants may be part of a control group, where you they be treated by MINST and provided with a placebo mouthwash The placebo mouthwash does not contain the active ingredient which reduces inflammation. Neither the participants nor the investigators can decide or be aware of which mouthwash the participants be given, as this will be determined randomly and the two mouthwash packages look the same.
The duration of the study will be over six months and will consist of a total of seven appointments. The aim of this study is to assess whether we can achieve better outcomes using this mouthwash and the healing of thegums will be assessed clinically. In addition, other parameters such as saliva samples, blood samples and plaque samples will be collected throughout the study, which allows us to examine the healing process in more detail and will help us understand how exactly the combination of MINST and the mouthwash improve healing.
Read the detailed description
This is a pilot randomised controlled trial comparing patients being treated with MINST non-surgical therapy with an adjunctive test or placebo mouthwash. This will be a single centre trial in the Department of Periodontology at Guy's Dental Hospital. Patients will be recruited and treated at this centre as per the inclusion criteria. The primary outcome is PPD reduction at 6 months in test vs control group, and the secondary outcomes are CAL reduction at 6 months, changes in inflammatory/tissue degradation/repair biomarkers in saliva and GCF between baseline and 6 months post-treatment.
- Conditions
- Periodontal Diseases, Periodontitis
- Being tested
- IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwash, Placebo mouthwash
- Keywords
- MINST, non-surgical, mouthwash
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwashDevice
adjunctive anti-inflammatory mouthwash
Placebo mouthwashDevice
Contains all the inactive ingredients as the test mouthwash without the LXA4
| Study group | Role | What they receive |
|---|---|---|
| MINST + test adjunctive anti-inflammatory mouthwash | Experimental | Patients being treated with MINST non-surgical therapy with an adjunctive test mouthwash (IsoDent Paro Strong) Receives: Device: IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwash |
| MINST + placebo mouthwash | Placebo comparator | Patients being treated with MINST non-surgical therapy with an adjunctive placebo mouthwash Receives: Device: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
Measure of depth of periodontal pocket taken with periodontal probe (in mm)
Measured: 6 months
Secondary outcomes (5)
Pocket closure
Reduction of pocket below 5 mm
Measured: 6 months
Clinical attachment level
Measure of periodontal attachment level taken with periodontal probe (in mm) (sum of pocket depth and gingival recession)
Measured: 6 months
Patient-related outcome measures
OHIP-14 score recorded by patients in OHIP-14 questionnaire
Measured: 6 months
Composite outcome
Combination of reduction of pocket depth<5mm and clinical attachment level gain of at least 3 mm (baseline- 3 months)
Measured: 6 months
Changes in biomarkers
Changes in levels of mcirobial, inflammatory and host-response biomarkers in gingival crevicular fluid, subgingival plaque, saliva and blood at different points after treatment
Measured: day 1, day 7, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203872
- Sponsor's protocol ID
- 343438
- Acronym
- AIRTIM
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Van Dyke TE, Sima C. Understanding resolution of inflammation in periodontal diseases: Is chronic inflammatory periodontitis a failure to resolve? Periodontol 2000. 2020 Feb;82(1):205-213. doi: 10.1111/prd.12317.
PubMed 31850636Serhan CN, Chiang N. Resolution phase lipid mediators of inflammation: agonists of resolution. Curr Opin Pharmacol. 2013 Aug;13(4):632-40. doi: 10.1016/j.coph.2013.05.012. Epub 2013 Jun 6.
PubMed 23747022Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.
PubMed 26257238
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Inflammation-resolution Therapy in Minimally-invasive Treatment of Deep Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07203872
- Acronym / sponsor ID
- AIRTIM / 343438
- Conditions
- Periodontal Diseases, Periodontitis
- Keywords
- MINST, non-surgical, mouthwash
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 2 Oct 2025 (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.
The aim of this study is to assess whether and how a mouthwash containing an ingredient that reduces inflammation in combination with a recently developed treatment is more effective at improving advanced gum disease. Advanced gum disease, also called periodontitis, is an inflammation of the gums which results in decrease in bone levels supporting teeth and can result in tooth loss. Minimally invasive non-surgical treatment (MINST) is a type of deep cleaning of teeth which involves removal of plaque beneath the gum margin and reduces inflammation. In this trial we will assess the additional benefits of combining deep cleaning (MINST) with the use of a mouthwash known to have a beneficial effect on tissue healing by helping the body to 'switch off' inflammation in periodontitis. Participants may be part of a control group, where you they be treated by MINST and provided with a placebo mouthwash The placebo mouthwash does not contain the active ingredient which reduces inflammation. Neither the participants nor the investigators can decide or be aware of which mouthwash the participants be given, as this will be determined randomly and the two mouthwash packages look the same.
The duration of the study will be over six months and will consist of a total of seven appointments. The aim of this study is to assess whether we can achieve better outcomes using this mouthwash and the healing of thegums will be assessed clinically. In addition, other parameters such as saliva samples, blood samples and plaque samples will be collected throughout the study, which allows us to examine the healing process in more detail and will help us understand how exactly the combination of MINST and the mouthwash improve healing.
Detailed description
This is a pilot randomised controlled trial comparing patients being treated with MINST non-surgical therapy with an adjunctive test or placebo mouthwash. This will be a single centre trial in the Department of Periodontology at Guy's Dental Hospital. Patients will be recruited and treated at this centre as per the inclusion criteria. The primary outcome is PPD reduction at 6 months in test vs control group, and the secondary outcomes are CAL reduction at 6 months, changes in inflammatory/tissue degradation/repair biomarkers in saliva and GCF between baseline and 6 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINST + test adjunctive anti-inflammatory mouthwash | Experimental | Device: IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwashPatients being treated with MINST non-surgical therapy with an adjunctive test mouthwash (IsoDent Paro Strong) |
| MINST + placebo mouthwash | Placebo comparator | Device: Placebo mouthwashPatients being treated with MINST non-surgical therapy with an adjunctive placebo mouthwash |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 70
- Diagnosis of periodontitis stage III-IV
- Presence of at least 1 deep intrabony defect (both PPD and radiographic defects >6mm)
- Full-mouth dichotomous plaque score>30%
- Willing to voluntarily sign the informed consent.
Key exclusion criteria (9 listed)
- Previous periodontal treatment to the study site within 6 months
- Use of systemic antibiotics within 3 months
- Weekly regular use of non-steroidal anti-inflammatory drugs
- Contributing medical history according to the examining clinician (e.g. diabetes mellitus)
- Smoking history (current or within 5 years)
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 |
|---|---|---|
| IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwashadjunctive anti-inflammatory mouthwash | Device | MINST + test adjunctive anti-inflammatory mouthwash |
| Placebo mouthwashContains all the inactive ingredients as the test mouthwash without the LXA4 | Device | MINST + placebo mouthwash |
Primary outcome
Probing pocket depth
Time frame: 6 months
Measure of depth of periodontal pocket taken with periodontal probe (in mm)
5 secondary outcomes
Pocket closure
Time frame: 6 months
Clinical attachment level
Time frame: 6 months
Patient-related outcome measures
Time frame: 6 months
Composite outcome
Time frame: 6 months
Changes in biomarkers
Time frame: day 1, day 7, 1 month, 3 months, 6 months
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 2 Oct 2025.
- Background: PubMed 31850636Van Dyke TE, Sima C. Understanding resolution of inflammation in periodontal diseases: Is chronic inflammatory periodontitis a failure to resolve? Periodontol 2000. 2020 Feb;82(1):205-213. doi: 10.1111/prd.12317.
- Background: PubMed 23747022Serhan CN, Chiang N. Resolution phase lipid mediators of inflammation: agonists of resolution. Curr Opin Pharmacol. 2013 Aug;13(4):632-40. doi: 10.1016/j.coph.2013.05.012. Epub 2013 Jun 6.
- Background: PubMed 26257238Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwash in people with Periodontal Diseases and Periodontitis, run by Guy's and St Thomas' NHS Foundation Trust 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 5 inclusion and 9 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 2 Oct 2025. 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?
Contact Luigi Nibali (+44 (0)20 7123 4843, luigi.nibali@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07203872, which also lists 3 linked publications.
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 2 Oct 2025.