Inflammation-resolution Therapy in MINST of Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial

NCT07203872 | Not Yet Recruiting

• 1 other identifier: 343438
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Periodontal Diseases; Periodontitis

Keywords

MINST; non-surgical; mouthwash

Outcome Measures

Primary Outcomes (1)

• Probing pocket depth

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

  6 months

Secondary Outcomes (5)

• Pocket closure

  6 months

• Clinical attachment level

  6 months

• Patient-related outcome measures

  6 months

• Composite outcome

  6 months

• Changes in biomarkers

  day 1, day 7, 1 month, 3 months, 6 months

Study Arms (2)

MINST + test adjunctive anti-inflammatory mouthwash

EXPERIMENTAL

Patients being treated with MINST non-surgical therapy with an adjunctive test mouthwash (IsoDent Paro Strong)

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

Device: Placebo mouthwash

Interventions

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

adjunctive anti-inflammatory mouthwash

MINST + test adjunctive anti-inflammatory mouthwash

Placebo mouthwash DEVICE

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

MINST + placebo mouthwash

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

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

London, SE1 9RT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 31850636 BACKGROUND

• Serhan 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.

  PMID: 23747022 BACKGROUND

• Nibali 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.

  PMID: 26257238 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Luigi Nibali

CONTACT

+44 (0)20 7123 4843; luigi.nibali@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 2, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

GB (1)