ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

AEHMPP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

periodontal disease

periodontal inflammation

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Oral and Gastrointestinal

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]

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]

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]

Baseline and 3 months post-intervention commencement

Primary outcome [2]

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]

Baseline and 3 months post-intervention commencement

Secondary outcome [1]

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]

Baseline and 3 months post-intervention commencement

Secondary outcome [2]

Difference in mean change of probing depth level was assessed using periodontal probes.

Timepoint [2]

Baseline and 3 months post-intervention commencement

Secondary outcome [3]

Difference in mean change of clinical attachment level, using periodontal probes.

Timepoint [3]

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

Sex

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

6/02/2018

Date of last participant enrolment

Anticipated

Actual

8/05/2018

Date of last data collection

Anticipated

4/09/2018

Actual

Sample size

Target

40

Accrual to date

Final

34

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Marche Area

Funding & Sponsors

Funding source category [1]

University

Name [1]

Polytechnic University of Marche

Address [1]

Via Tronto 10, Ancona

Country [1]

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]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comitato Etico Regionale delle Marche

Ethics committee address [1]

Azienda Ospedaliero-Universitaria Ospedali Riuniti,  Via Conca 71, 60126 Ancona

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

10/11/2017

Approval date [1]

22/03/2018

Ethics approval number [1]

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

Prof Giovanna Orsini

Address

Department of Clinical Sciences and Stomatology, Polytechnic University of Marche,
Via Tronto 10, Ancona

Country

Italy

Phone

+393472483290

Fax

+390712206221

Email

[email protected]

Contact person for public queries

Name

Angelo Putignano

Address

Department of Clinical Sciences and Stomatology, Polytechnic University of Marche,
Via Tronto 10, 60126 Ancona

Country

Italy

Phone

+390712206224

Fax

+390712206221

Email

[email protected]

Contact person for scientific queries

Name

Giovanna Orsini

Address

Department of Clinical Sciences and Stomatology, Polytechnic University of Marche,
Via Tronto 10, 60126 Ancona

Country

Italy

Phone

+393472483290

Fax

+390712206221

Email

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23810	Other				final published paper

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4085	Plain language summary	No		The final study sample consisted of 34 healthy in... [More Details]
4714	Study results article	Yes		Front Physiol. 2019 May 22;10:632. doi: 10.3389/fp... [More Details]	375405-(Uploaded-19-06-2019-16-02-40)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Efficacy of an all-natural polyherbal mouthwash in patients with periodontitis: A single-blind randomized controlled trial.	2019	https://dx.doi.org/10.3389/fphys.2019.00632

N.B. These documents automatically identified may not have been verified by the study sponsor.