Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000215729
Ethics application status
Approved
Date submitted
2/08/2021
Date registered
7/02/2022
Date last updated
7/02/2022
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of two different mouthrinses on patients with gingival inflammation.
Scientific title
A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of two different mouthrinses on patients with gingival inflammation.
Secondary ID [1] 304939 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
periodontal disease 323088 0
periodontal inflammation 323089 0
Gingivitis 324218 0
SARS-CoV-2 infection 325087 0
Condition category
Condition code
Alternative and Complementary Medicine 320662 320662 0 0
Herbal remedies
Oral and Gastrointestinal 320663 320663 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The following mouthrinses will be evaluated:
-Group A: containing Propolis resin extract (1:3), Plantago lanceolata leaves extract (1:10), Salvia officinalis leaves extract (1:1) and 1.75% of essential oils from Salvia officinalis, Syzygium aromaticum buds, Mentha piperita leaves, Commiphora myrrha oleoresin and Pistacia lentiscus oleoresin (Fitomedical snc, Binasco, Milan, Italy).
- Group B: containing 0,09% of chlorhexidine (CHX) and CITROX® (formulation deriving from the extract of bitter orange peel) (Curaprox Italia S.r.l. , Bolzano, Italy).
The patients will use the assigned mouthrinses twice a day for two weeks. At baseline a single examiner , with more than 8 years of practice, will collect the clinical parameters. All patients will receive a written instruction of the tested mouthrinses and their right dosage. The participants will be instructed to gargle 10 ml of the mouthrinse for a period of 60 seconds, after which the mouthrinse is spit out. Moreover, they will be instructed to not rinse/eat anything for 30 minutes after mouthrinse use. The patients will continue to perform their routine oral home care, adding only the assigned mouthrinse. Patient self-report diary will be use to monitor adherence of the patient to intervention.
Intervention code [1] 322126 0
Treatment: Other
Comparator / control treatment
Group C contains only 0.12% of CHX and it will be used as gold standard.
Control group
Active

Outcomes
Primary outcome [1] 328487 0
The bleeding index on 6 surfaces using full mouth bleeding score.
Timepoint [1] 328487 0
Baseline; 2 weeks post intervention commencement
Secondary outcome [1] 399153 0
The plaque index on 6 surfaces using full mouth plaque score (FMPS).
Timepoint [1] 399153 0
Baseline; 2 weeks post intervention commencement
Secondary outcome [2] 402705 0
The patient taste appreciation using 10-cm Visual Analogue Score (VAS).
Timepoint [2] 402705 0
Baseline; 2 weeks post intervention commencement
Secondary outcome [3] 402706 0
The extrinsic stain using modified Lobene stain index.
Timepoint [3] 402706 0
Baseline; 2 weeks post intervention commencement
Secondary outcome [4] 405686 0
Detection and concentration of SARS COV-2
Timepoint [4] 405686 0
Baseline; 2 weeks post intervention commencement

Eligibility
Key inclusion criteria
minimum of 20 teeth, good physical health, gingivitis, periodontitis stages I or II
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) active caries
2) wearers of dentures and of orthodontic appliances;
3) severe malocclusion;
4) use of oral antiseptics in the previous three months;
5) subjects with medical disorders;
6) undergoing antibiotic or other antimicrobial therapy in the previous 3 months;
7) the presence of any systemic disease that could alter the production or composition of the saliva or dental plaque;
8) individuals with an allergy to any ingredients used in the study;
9) pregnant women.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random table was performed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will be a single-center, randomized, double-blind, parallel-group clinical trial. Calculation of number of subjects will be centred on the principal outcome, i.e. the difference of full mouth bleeding score (FMBS) values between groups. Group sample sizes of 25 achieve 80% power to detect non -inferiority using one-sided, two sample equal-variance t-test. The margin of non-inferiority is -4.0. The actual difference between the means is assumed to be 0.0. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviation of 5.0 in both groups. Since an attrition of 10% of the subjects is assumed, 82 subjects will planned to be included

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
14/04/2022
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment outside Australia
Country [1] 24020 0
Italy
State/province [1] 24020 0
Marche

Funding & Sponsors
Funding source category [1] 309322 0
University
Name [1] 309322 0
Polytechnic University of Marche
Country [1] 309322 0
Italy
Primary sponsor type
University
Name
Polytechnic University of Marche
Address
Dipartimento di Scienze Cliniche Specialistiche ed Odontostomatologiche, Università Politecnica delle Marche, Via Tronto 10, 60126 Ancona
Country
Italy
Secondary sponsor category [1] 310294 0
None
Name [1] 310294 0
Address [1] 310294 0
Country [1] 310294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309146 0
Comitato Etico Regionale delle Marche
Ethics committee address [1] 309146 0
Ethics committee country [1] 309146 0
Italy
Date submitted for ethics approval [1] 309146 0
13/05/2021
Approval date [1] 309146 0
24/06/2021
Ethics approval number [1] 309146 0
MTHW-CLX/HERB-2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113146 0
Prof Giovanna Orsini
Address 113146 0
Department of Clinical Sciences and Stomatology, Polytechnic University of Marche,
Via Tronto 10, 60236, Ancona
Country 113146 0
Italy
Phone 113146 0
+393472483290
Fax 113146 0
Email 113146 0
[email protected]
Contact person for public queries
Name 113147 0
Angelo Putignano
Address 113147 0
Department of Clinical Sciences and Stomatology, Polytechnic University of Marche,
Via Tronto 10, 60126 Ancona
Country 113147 0
Italy
Phone 113147 0
+390712206224
Fax 113147 0
Email 113147 0
[email protected]
Contact person for scientific queries
Name 113148 0
Giovanna Orsini
Address 113148 0
Department of Clinical Sciences and Stomatology, Polytechnic University of Marche,
Via Tronto 10, 60126 Ancona
Country 113148 0
Italy
Phone 113148 0
+393472483290
Fax 113148 0
Email 113148 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Policy of our University and Ethics Committee.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA comprehensive SARS-CoV-2-human protein-protein interactome reveals COVID-19 pathobiology and potential host therapeutic targets.2023https://dx.doi.org/10.1038/s41587-022-01474-0
N.B. These documents automatically identified may not have been verified by the study sponsor.