The INORE study (INulin and Oral REsilience)

Recruiting

• Conditions: Oral health

• Registration Number: NL-OMON23990
• Lead Sponsor: SH-TKI, ACTA, TNO, Philips, Wrigley

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

1.Willing and able to give written informed consent and willing and able to comply to all study procedures
2.Mentally-competent and 16-35 years
3.ASA I, healthy as assessed by a medical questionnaire
4.Non-smoking: definition non-smoker: <1 cigarette every day for at least one year (Lie, Timmerman et al. 1998)
5.Minimum of 20 natural teeth: at least one un-crowned first or second molar must be present in each quadrant
6.Having visited the dentist for a regular check-up within the last year and having finished the necessary treatment(s)
7.More than 20% and less than 50% bleeding on probing

Exclusion Criteria

1.Not meeting the inclusion criteria
2.ACTA dental student or ACTA employee
3.InHolland oral hygiene student or InHolland employee
4.Participation in a clinical study within the previous 30 days
5.Allergy/intolerance to the ingredients of the test product

General health and use of medication:
6.Smoker
7.Abuse of drugs or alcohol
8.Self-reported pregnancy or breastfeeding
9.Use of antibiotics during the last 3 months
10.Use of anti-inflammatory drugs on a regular basis
11.ASA II or more
12.Prescribed medication (except for contraceptives)

Oral health:
13.Overt dental caries
14.DMFS score > 15
15.Anyone with a dental pocket probing depth =4-5mm with bleeding on probing plus attachment loss = 2 mm (Dutch Periodontal Screening Index score 3+/ 4) or a pocket = 6 mm
16.Clearly inflamed gingiva at the screening, presented as >50% bleeding on probing (BOP)
17.Removable (partial) dentures
18.Removable night guard
19.Oral and/or peri-oral piercings
20.Apparent oral lesions (aphthous ulcers excluded)
21.Presence of orthodontic banding (except for lingual retention wire)
22.Ongoing or planned elective dental treatment involving endodontic treatment and crown and bridge preparation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the changes in microbial composition of the oral microbiome after two weeks of regular oral hygiene and use of inulin-containing mouth rinse (wash-in phase), followed by two weeks abstaining from any oral hygiene combined with the use of inulin-mouth rinse (experimental gingivitis phase), and the recovery period of two weeks with normal oral hygiene combined with inulin-mouth rinse use (recovery phase) compared to the baseline and a mouth-rinse containing a placebo rinse.

Secondary Outcome Measures

Name	Time	Method
To evaluate the changes 1) in gingival light absorption (GLA), 2) in proportion of the red fluorescing plaque (RFP) and 3) in gingival bleeding on marginal probing (BOMP) after two weeks of regular oral hygiene and use of inulin-containing mouth rinse (wash-in phase), followed by two weeks abstaining from any oral hygiene combined with the use of inulin-mouth rinse (experimental gingivitis phase), and the recovery period of two weeks with normal oral hygiene combined with inulin-mouth rinse use (recovery phase) compared to the baseline and a mouth-rinse containing a placebo rinse.