Condition category
Oral Health
Date applied
23/10/2020
Date assigned
01/12/2020
Last edited
01/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Bacteria and microbial biofilm (plaque) are the most important causes of gum disease. Plaque control and efficient plaque removal are the two keystones for maintaining good oral health. Daily plaque accumulation can be prevented by tooth brushing and flossing, while plaque and calculus (hardened plaque) removal is performed during professional oral hygiene. However, efficient plaque control is not easy to obtain. Different toothpastes, gels and mouthwashes have been developed in an attempt to reduce bacterial adhesion to the teeth. Currently the gold standard is chlorhexidine (CHX), most widely recommended as a mouthwash, especially as a home-care treatment. Despite its proven antibacterial activity, CHX has been associated with staining and increased calculus formation. PerioTabsTM are a NitrAdineTM-based teeth and gum brushing solution. Several studies have demonstrated the anti-biofilm activity of NitrAdine in patients wearing removable dentures and orthodontic appliances. The aims of this study are to evaluate the effectiveness of 10-day use of PerioTabsTM combined with regular toothbrushing in patients suffering from gingivitis (gum inflammation), and secondly to investigate the presence of calculus, tooth discolouration and other adverse reactions.

Who can participate?
Adult patients with gingivitis

What does the study involve?
Patients are instructed to uses PerioTabsTM for 2 to 3 minutes once a day for 10 days in the evening. Each patient receives one PerioTabsTM box containing 10 small effervescent tablets and a container. Every evening, a fresh brushing solution is prepared by dissolving one small tablet in 15 ml of warm water using the provided container; while the tablet is dissolving, the toothbrush is immersed in the solution and left for 15 minutes, the time required for the tablet to completely dissolve. Patients then brush their teeth and gums (inner and outer) with the solution. It is recommended to immerse the toothbrush 2-3 times in the solution for a few seconds and brush again. After 2 minutes of brushing, patients are asked to rinse thoroughly their mouth with water and discard the remaining solution. No toothpaste or mouth rinse solution is used after the PerioTabsTM brushing session. The next morning, patients perform their routine daily oral hygiene using regular toothpaste. This scheme is maintained for the 10-day course of the treatment. Participants will be asked to attend professional oral hygiene before they begin the study and at follow-up visits at 10 days and 36 weeks after the beginning of the study. Participants will be asked to record the treatment’s unexpected effects in a diary.

What are the possible benefits and risks of participating?
Patients will be given a PerioTabsTM box and 10 capsules and will receive instructions for use. Patients will be able to contact their doctor for any eventuality. Patients will be regularly followed up to 6 months after the end of therapy.

Where is the study run from?
SICOR private dental office (Italy)

When is the study starting and how long is it expected to run for?
December 2017 to May 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof. Paolo Giacomo Arduino
paologiacomo.arduino@unito.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paolo G. Arduino

ORCID ID

https://orcid.org/0000-0002-8798-7834

Contact details

Via Nizza 230
Turin
10100
Italy
+39 (0)116331522
paologiacomo.arduino@unito.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Evaluating the clinical efficiency of PerioTabsTM, a new home-care based oral hygiene approach, for patients suffering from gingivitis: a prospective open-label single-arm pilot study

Acronym

PTBGNV

Study hypothesis

The use of PerioTabsTM, combined with regular tooth brushing for 10 days, could be useful in reducing plaque index and gingival index in patients suffering from gingivitis.

Ethics approval

Approved 01/09/2019, CIR-Dental School (Turin, Via Nizza 230, Italy; +39 (0)11 6331522; email: not provided), ref: CIR-PO-pga2019/09

Study design

Prospective open-label single-arm pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Gingivitis

Intervention

This is a prospective, open-label study, that involves giving a specific preparation (a non-antibiotic biofilm removal formulation based on NitrAdineTM) to a cohort of subjects with diagnosed gingivitis. Caucasian patients, attending a private practice office, Turin, Italy, are selected for the present study.

Patients are instructed to uses PerioTabsTM for 2 to 3 minutes once a day for 10 days in the evening. Each participating patient receives one PerioTabsTM box containing 10 small effervescent tablets and a container. Every evening, a fresh brushing solution is prepared by dissolving one small tablet in 15 ml of warm water using the provided container; while the tablet is dissolving, the toothbrush is immersed in the solution and left for 15 minutes, the time required for the tablet to completely dissolve. Patients then brush their teeth and gums (inner and outer) with the solution. It is recommended to immerse the toothbrush 2-3 times in the solution for a few seconds and brush again. After 2 minutes of brushing, patients are asked to rinse thoroughly their mouth with water and discard the remaining solution. No toothpaste or mouth rinse solution is used after the PerioTabsTM brushing session. The next morning, patients perform their routine daily oral hygiene using regular toothpaste. This scheme is maintained for the 10-day course of the treatment.

Intervention type

Drug

Phase

Not Applicable

Drug names

PerioTabsTM

Primary outcome measure

1. Gingival inflammation measured using Gingival Index (bleeding on probing) at baseline at 10 days and 36 weeks
2. Plaque formation measured using Plaque Index (PI) at baseline at 10 days and 36 weeks

Secondary outcome measures

1. Reported adverse events due to the treatment assessed from patient notes at the end of the study
2. Unexpected effects assessed from patient diary records collected at the end of the study

Overall trial start date

01/12/2017

Overall trial end date

01/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥ 18
2. Gingivitis diagnosis
3. No detectable oral mucosal lesions
4. Able to complete the present clinical trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Total final enrolment

30

Participant exclusion criteria

1. Unable or unwilling to provide informed consent
2. Significant psychiatric or cognitive impairment
3. Pregnant or breast-feeding women
4. Subjects with an history of allergy for ingredients present in PerioTabsTM
5. Subjects with carious teeth
6. Subjects affected by periodontitis or suffering from oral acute conditions requiring antibiotics

Recruitment start date

01/06/2018

Recruitment end date

01/11/2018

Locations

Countries of recruitment

Italy

Trial participating centre

SICOR dental private practice
Corso Sicilia 51
Turin
10133
Italy

Sponsor information

Organisation

University of Turin

Sponsor details

Via Nizza 230
Turin
10100
Italy
+39 (0)116331522
paologiacomo.arduino@unito.it

Sponsor type

University/education

Website

https://www.dentalschool.unito.it/it

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of the primary and secondary endpoints along with any other reportable data will be published in a peer-reviewed journal.

IPD sharing statement:
The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/01/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/11/2020: Trial's existence confirmed by CIR-Dental School.