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NCT Number: NCT07203872

Inflammation-resolution Therapy in MINST of 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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral Clinical Research Unit (OCRU) at King's College London (KCL)

London, SE1 9RT, United Kingdom

Location contact

Luigi Nibali, Professor

CONTACT

[email protected]

02071888801 ext. 57284

Luigi Nibali, Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Presence of systemic diseases, which affects bone and/or connective tissue metabolism
  • Concurrent participation in other clinical studies.
  • Pregnant or breastfeeding.

Treatment and study plan

IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwash

Device

adjunctive anti-inflammatory mouthwash

Placebo mouthwash

Device

Contains all the inactive ingredients as the test mouthwash without the LXA4

Primary outcomes

  1. Probing pocket depth

    Time frame: 6 months

    Measure of depth of periodontal pocket taken with periodontal probe (in mm)

Secondary outcomes

  1. Pocket closure

    Time frame: 6 months

    Reduction of pocket below 5 mm

  2. Clinical attachment level

    Time frame: 6 months

    Measure of periodontal attachment level taken with periodontal probe (in mm) (sum of pocket depth and gingival recession)

  3. Patient-related outcome measures

    Time frame: 6 months

    OHIP-14 score recorded by patients in OHIP-14 questionnaire

  4. Composite outcome

    Time frame: 6 months

    Combination of reduction of pocket depth<5mm and clinical attachment level gain of at least 3 mm (baseline- 3 months)

  5. Changes in biomarkers

    Time frame: day 1, day 7, 1 month, 3 months, 6 months

    Changes in levels of mcirobial, inflammatory and host-response biomarkers in gingival crevicular fluid, subgingival plaque, saliva and blood at different points after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Nibali

CONTACT

[email protected]

+44 (0)20 7123 4843

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • King's College London

Registry information

Official study title

Adjunctive Inflammation-resolution Therapy in Minimally-invasive Treatment of Deep Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial

Acronym: AIRTIM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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