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| Name | Class |
|---|---|
| King's College London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINST + test adjunctive anti-inflammatory mouthwash | Experimental | Patients being treated with MINST non-surgical therapy with an adjunctive test mouthwash (IsoDent Paro Strong) |
|
| MINST + placebo mouthwash | Placebo Comparator | Patients being treated with MINST non-surgical therapy with an adjunctive placebo mouthwash |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwash | Device | adjunctive anti-inflammatory mouthwash |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depth | Measure of depth of periodontal pocket taken with periodontal probe (in mm) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pocket closure | Reduction of pocket below 5 mm | 6 months |
| Clinical attachment level | Measure of periodontal attachment level taken with periodontal probe (in mm) (sum of pocket depth and gingival recession) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Nibali | Contact | +44 (0)20 7123 4843 | luigi.nibali@kcl.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Clinical Research Unit (OCRU) at King's College London (KCL) | London | SE1 9RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31850636 | Background | 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. | |
| 23747022 | 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. |
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| Placebo mouthwash | Device | Contains all the inactive ingredients as the test mouthwash without the LXA4 |
|
| 6 months |
| Patient-related outcome measures | OHIP-14 score recorded by patients in OHIP-14 questionnaire | 6 months |
| Composite outcome | Combination of reduction of pocket depth<5mm and clinical attachment level gain of at least 3 mm (baseline- 3 months) | 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 | day 1, day 7, 1 month, 3 months, 6 months |
| 26257238 | 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. |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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