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Trial registered on ANZCTR


Registration number
ACTRN12618001192279
Ethics application status
Approved
Date submitted
26/06/2018
Date registered
17/07/2018
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Anti-inflammatory effect of an herbal mouthwash in periodontal patients
Scientific title
Anti-inflammatory effect of an herbal mouthwash in periodontal patients
Secondary ID [1] 295283 0
Nil
Universal Trial Number (UTN)
Trial acronym
AEHMPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
periodontal disease 308520 0
periodontal inflammation 308521 0
Condition category
Condition code
Alternative and Complementary Medicine 307491 307491 0 0
Herbal remedies
Oral and Gastrointestinal 307492 307492 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
To assess the anti-inflammatory effect of a poly herbal mouthwash in periodontal patients after 3-month use and to compare it with placebo.
The mouthwash dose administered was 1ml diluted in a measuring cup (15ml) of water twice daily, for 1 minute
Participants adherence to the intervention was monitored by mouthwash bottle returns.
Intervention code [1] 301650 0
Treatment: Other
Comparator / control treatment
Control group: patients using placebo mouthwash
Test group: patients using herbal mouthwash
Placebo mouthwash was prepared using 2 ml of glycerin (sweetening agent), cinnamon and vanilla flavoring agents, and brown food coloring, dissolved in 1 liter of distilled water and placed in 100 ml brown-colored opaque bottles marked only with number’s patient.
Control group
Placebo

Outcomes
Primary outcome [1] 306464 0
Differences in mean reduction of inflammation index.
Inflammation was measured by recording the bleeding index FMBS (Full Mouth Bleeding Score) on 6 dental surfaces of all teeth, using periodontal probes, according to the criteria of Ainamo and Bay (1975).
Timepoint [1] 306464 0
Baseline and 3 months post-intervention commencement
Primary outcome [2] 306465 0
Mouthwash safety was assessed using a questionnaire (specifically designed for this study) in which patients reported any adverse events, including redness of oral mucosa, mouth burning, desquamation, oral dryness, hard tissues brown spots, alteration of taste.
Timepoint [2] 306465 0
Baseline and 3 months post-intervention commencement
Secondary outcome [1] 348625 0
Difference in mean change of plaque accumulation index.
This was assessed using plaque index FMPS (Full Mouth Plaque Score), using plaque detectors, according to the criteria of O’Leary (1967).
Timepoint [1] 348625 0
Baseline and 3 months post-intervention commencement
Secondary outcome [2] 348626 0
Difference in mean change of probing depth level was assessed using periodontal probes.
Timepoint [2] 348626 0
Baseline and 3 months post-intervention commencement
Secondary outcome [3] 348627 0
Difference in mean change of clinical attachment level, using periodontal probes.
Timepoint [3] 348627 0
Baseline and 3 months post-intervention commencement

Eligibility
Key inclusion criteria
Systemically healthy, minimum 20 teeth, smoker and no smoker, diagnosis of severe or moderate periodontitis
Minimum age
20 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of antibiotics and anti-inflammatory drugs in previous 6 months, presence of orthodontic appliance, pregnant or lactating females, allergy to the mouthwash ingredients

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation was made according to previous studies (Mehta et al. 2013; Aspalli et al. 2014; Pradeep et al. 2016). The expected mean bleeding score at the end of the follow-up was evaluated to be reduced in the experimental group compared to the control (placebo) group. Using an unpaired t-test and assuming an alpha error of 0.05 and an expected withdrawal/dropout rate of 10%, a minimum of 20 participants per group were requested.
Mann-Whitney and Wilcoxon tests will be used to evaluate the data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10587 0
Italy
State/province [1] 10587 0
Marche Area

Funding & Sponsors
Funding source category [1] 299878 0
University
Name [1] 299878 0
Polytechnic University of Marche
Address [1] 299878 0
Via Tronto 10, Ancona
Country [1] 299878 0
Italy
Primary sponsor type
University
Name
Istitutional funds from Prof. Putignano and Prof Orsini
Address
Dipartimento di Scienze Cliniche Specialistiche ed Odontostomatologiche, Università Politecnica delle Marche, Via Tronto 10, 60126 Ancona
Country
Italy
Secondary sponsor category [1] 299229 0
None
Name [1] 299229 0
none
Address [1] 299229 0
none
Country [1] 299229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300747 0
Comitato Etico Regionale delle Marche
Ethics committee address [1] 300747 0
Azienda Ospedaliero-Universitaria Ospedali Riuniti, Via Conca 71, 60126 Ancona
Ethics committee country [1] 300747 0
Italy
Date submitted for ethics approval [1] 300747 0
10/11/2017
Approval date [1] 300747 0
22/03/2018
Ethics approval number [1] 300747 0
2017-0087 UN

Summary
Brief summary
Numerous studies on anti-plaque and anti-gingivitis agents provided strong evidence in favor of the use of antimicrobial agents such as mouthwashes as adjuncts to mechanical plaque control. Recently, essential oils containing mouthwashes have been demonstrated to be effective in reducing dental plaque and gingival inflammation. The present study was aimed to evaluate, after 3 months, the efficacy a newly-developed herbal mouthwash in patients suffering from moderate periodontal disease and to compare its efficacy to a placebo mouthwash.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84678 0
Prof Giovanna Orsini
Address 84678 0
Department of Clinical Sciences and Stomatology, Polytechnic University of Marche,
Via Tronto 10, Ancona
Country 84678 0
Italy
Phone 84678 0
+393472483290
Fax 84678 0
+390712206221
Email 84678 0
giovorsini@yahoo.com
Contact person for public queries
Name 84679 0
Prof Angelo Putignano
Address 84679 0
Department of Clinical Sciences and Stomatology, Polytechnic University of Marche,
Via Tronto 10, 60126 Ancona
Country 84679 0
Italy
Phone 84679 0
+390712206224
Fax 84679 0
+390712206221
Email 84679 0
a.putignano@univpm.it
Contact person for scientific queries
Name 84680 0
Prof Giovanna Orsini
Address 84680 0
Department of Clinical Sciences and Stomatology, Polytechnic University of Marche,
Via Tronto 10, 60126 Ancona
Country 84680 0
Italy
Phone 84680 0
+393472483290
Fax 84680 0
+390712206221
Email 84680 0
giovorsini@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary