Use of PerioTabsTM for patients with gingivitis
| ISRCTN | ISRCTN14006811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14006811 |
- Submission date
- 23/10/2020
- Registration date
- 01/12/2020
- Last edited
- 05/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Via Nizza 230
Turin
10100
Italy
 ORCID ID |
0000-0002-8798-7834 |
|---|---|
| Phone | +39 (0)116331522 |
| paologiacomo.arduino@unito.it |
Study information
| Study design | Prospective open-label single-arm pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| 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 |
| Study acronym | PTBGNV |
| Study objectives | 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(s) | Approved 01/09/2019, CIR-Dental School (Turin, Via Nizza 230, Italy; +39 (0)11 6331522; email: not provided), ref: CIR-PO-pga2019/09 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2017 |
| Completion date | 01/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Aged ≥ 18 2. Gingivitis diagnosis 3. No detectable oral mucosal lesions 4. Able to complete the present clinical trial |
| Key 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 |
| Date of first enrolment | 01/06/2018 |
| Date of final enrolment | 01/11/2018 |
Locations
Countries of recruitment
- Italy
Study participating centre
Turin
10133
Italy
Sponsor information
University/education
Via Nizza 230
Turin
10100
Italy
| Phone | +39 (0)116331522 |
|---|---|
| paologiacomo.arduino@unito.it | |
| Website | https://www.dentalschool.unito.it/it |
"ROR" |
https://ror.org/048tbm396 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2022 | 05/10/2022 | Yes | No |
Editorial Notes
05/10/2022: Publication reference added.
03/11/2020: Trial's existence confirmed by CIR-Dental School.
