ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000421730p

Ethics application status

Submitted, not yet approved

Date submitted

28/01/2022

Date registered

14/03/2022

Date last updated

14/03/2022

Date data sharing statement initially provided

14/03/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of polyherbal mouthwash versus 0.2% Chlorhexidine mouthwash on patients for dental plaque, gingivitis, and gingival bleeding in Faisalabad, Pakistan: A randomized comparative clinical trial..

Scientific title

Effects of polyherbal mouthwash versus 0.2% Chlorhexidine mouthwash on patients for dental plaque, gingivitis, and gingival bleeding in Faisalabad, Pakistan: A randomized comparative clinical trial.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1273-7146

Trial acronym

Linked study record

Health condition

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

Dental plaque

Gingivitis

Gingival bleeding

Condition category

Condition code

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

The subjects in intervention arm shall receive herbal mouthwash, the product under test. Subject will be counseled to take 10ml of the mouthwash and rinse mouth with it for 1 minute, after brushing teeth. The frequency will be once daily at night for 30 days. The herbal mouthwash will contain essential oil extracts of clove, cardamom, cinnamon, peppermint leaves and fennel, and aqueous extracts of neem and miswak. The adherence shall be monitored by counting the returned of unused mouthwash bottles.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The subjects in intervention arm shall receive 0.2% chlorhexidine gluconate mouthwash, the standard product. Subject will be counseled to take 10ml of the mouthwash and rinse mouth with it for 1 minute, after brushing teeth. The frequency will be once daily at night for 30 days. The adherence shall be monitored by counting the returned of unused mouthwash bottles.

Control group

Active

Outcomes

Primary outcome [1]

Turesky Modification of the Quigley–Hein dental plaque index
The index score ranges from 0 to 5 as follows:
0= no plaque
1= separate flecks of plaque at the cervical margin of the tooth
2= a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth
3= a band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth
4= plaque covering at least one-third but less than two-thirds of the crown of the tooth
5= plaque covering two-thirds or more of the crown of the tooth

Timepoint [1]

At time of recruitment
At 30 days post-intervention commencement

Primary outcome [2]

Löe–Silness gingivitis index
The index score ranges from 0-4 as follows:

0= absence of inflammation
1= mild inflammation – slight change in color and little change in texture
2= moderate inflammation – moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing
3= severe inflammation – marked redness and hypertrophy. Tendency to spontaneous bleeding

Timepoint [2]

At time of recruitment
At 30 days post-intervention commencement

Primary outcome [3]

Sulcus Bleeding Index
The index score ranges from 0 to 5 as follows:

Score 0 – health looking papillary and marginal gingiva no bleeding on probing
Score 1 – healthy looking gingiva, bleeding on probing
Score 2 – bleeding on probing, change in color, no edema
Score 3 – bleeding on probing, change in color, slight edema
Score 4 –bleeding on probing, change in color, obvious edema
Score 5 –spontaneous bleeding, change in color, marked edema

Timepoint [3]

At time of recruitment
At 30 days post-intervention commencement

Secondary outcome [1]

Patient Satisfaction Level (designed specifically for this study)

This shall include 7 questions related to satisfaction to the treatment.
Each questions can be answered only in NO or YES. Satisfaction shall be based upon answering of questions. Questions shall be related to experience of participant of using the product.

Timepoint [1]

At the end of the study

Secondary outcome [2]

Adherence to treatment

It shall be assessed by checking number of empty or used bottles versus the unused bottles.

Timepoint [2]

It will be conducted after completion of intervention and before commencement of final data collection.

Secondary outcome [3]

Invitro culture sensitivity test

All subject of a group will be asked to open mouth and the investigator shall rub a cotton stick all around in the mouth and shall put it into a bottles containing normal saline. The bottles shall be mixed in a large container and shall be incubated at 37 Celsius for 24 hours. An inoculum shall be taken and shall be introduced into different petri dishes containing agar-medium for culturing of bacteria.
A drop of mouth wash under test shall be put in the medium in one location. After complete incubation of 3 days at 37 Celsius, the degree of inhibition shall be assessed to assess sensitivity.

Timepoint [3]

Sample will be taken at time of recruitment.

Eligibility

Key inclusion criteria

1. Patient with dental plaque and gingivitis
2. Patient with at least 28 teeth
3. Patient above age of 18 years
4. Patient below age of 70 years
5. Patient capable of giving consent

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Smokers & narcotic addicts
2. Pregnant and lactating patients
3. Patients taking anti-platelets and anti-coagulant medications
4. Foreign nationals
5. Patients having other infections
6. Patients having any disorders related to blood clotting
7. Dementia

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 shall be concealed to subject through use of coded labels so only Principal Investigator will know where the subject is allocated.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The data collected shall be analyzed by SPSS. Descriptive statistics including frequencies and percentages shall be presented for nominal and scale data respectively. In inferential statistics, correlation test will be applied to assess if there is any relation with group with indices and side effects. Further regression test will be applied to check if indices and side effects are dependent on group. ANOVA both one way and two way shall be run to determine intra and inter group variations in means. Paired sample t test, independent t test and chi-square test shall be run to determine significant difference between baseline data and final data.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/06/2022

Actual

Date of last participant enrolment

Anticipated

7/06/2022

Actual

Date of last data collection

Anticipated

7/07/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

PUNJAB

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr. Mustafa Ijaz

Address [1]

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Rd, Faisalabad City, Punjab 38000

Country [1]

Pakistan

Primary sponsor type

Individual

Name

Dr. Malik Hassan Mehmood

Address

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Rd, Faisalabad City, Punjab 38000

Country

Pakistan

Secondary sponsor category [1]

Individual

Name [1]

Dr. Rida Siddique

Address [1]

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Rd, Faisalabad City, Punjab 38000

Country [1]

Pakistan

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Institutional Review Board, Government College University Faisalabad

Ethics committee address [1]

Kotwali Rd, Government College University, Faisalabad City, Punjab 38000

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

15/12/2021

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This study is aimed for assessment of a herbal mouthwash on patients with dental plaque, gingivitis, gingival bleeding and its action comparison with standard 0.2% chlorhexidine mouthwash.  The study is designed as prospective, double blinded, randomized, active controlled clinical trial.  The endpoints will measured two times during the study, first at start, and second at finalizing.  The in-vitro tests shall also be conducted to confirm anti-bacterial activity of product in comparison to standard product.

Trial website

Trial related presentations / publications

Public notes

Dr. Mustafa Ijaz is an individual and is bearing the expenses of the study by himself and shall be the principal investigator of the project also.
Dr. Malik Hassan Mehmood, according to protocols followed in university, is primary sponsor and Co-PI of this study.

The material of optimum quality shall be procured from a vendor in Faisalabad. The material shall be kept separated and labelled.  The material shall be brought before an expert botanist for verification of material and issuance of specimen voucher.  After verification of each material, a lot number shall be allocated to each material.  
For collection of volatile oils, each material will be macerated with distilled water at 30 Celsius for 7 days.  The liquid shall be filtered and the macerate shall be subjected to Soxhlet distillator for collection of volatile oils.  The volatile oils shall be stored in amber colored bottles at room temperature and be allocated lot number
For making aqueous extract, the material shall be macerated in distilled water for 14 days.  After filtration, the filtrate shall be subjected to evaporation of water using rotary evaporator at 35 celcius, however caution will be taken that the extract is not so much dried.  A lightly viscous extract shall be taken out and shall be saved in amber colored bottles at room temperature.
The preparation, production and quality control shall be well-documented and batch controlled.  The extract and the product samples shall be tested for quantitative and qualitative analysis.  The result shall be attached with records, and upon this information, the release for usage by human will be considered.
The prepared mouthwash shall be stored in transparent plastic bottles and be stored at room temperature.  The bottle containing mouthwash for intervention Arm shall be marked as “A” and the bottle containing standard mouthwash for control arm shall be marked as “B”.  The label shall contain additional information like, production date, best before date, batch, produced by, precautions, usage and storage information.
The proposed main ingredients of mouthwash shall be:
1.	Essential oil extract of Clove
2.	Essential oil extract of Cardamom
3.	Essential oil extract of Cinnamon
4..	Essential oil extract of peppermint leaves
5.	Essential oil extract of Fennel
6.	Aqueous extract of Neem
7.	Aqueous extract of Miswak

Contacts

Principal investigator

Name

Dr Mustafa Ijaz

Address

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Rd, Faisalabad City, Punjab 38000

Country

Pakistan

Phone

+92412551354

Fax

mustafaijaz78@gmail.com

Contact person for public queries

Name

Mustafa Ijaz

Address

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Rd, Faisalabad City, Punjab 38000

Country

Pakistan

Phone

+92412551354

Fax

mustafaijaz78@gmail.com

Contact person for scientific queries

Name

Mustafa Ijaz

Address

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Rd, Faisalabad City, Punjab 38000

Country

Pakistan

Phone

+92412551354

Fax

mustafaijaz78@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All data after de-identification shall be shared.

When will data be available (start and end dates)?

Immediately following publication, no end date

Available to whom?

anyone who wishes to access it, only researchers who provide a methodologically sound proposal at discretion of Principal Investigator

Available for what types of analyses?

Available for meta-analysis

How or where can data be obtained?

By email to Principal Investigator at mustafaijaz78@gmail.com

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14404	Informed consent form				Informed consent shall be shared only as an eviden... [More Details]
14405	Ethical approval				Ethical approval will be uploaded once approval is... [More Details]

Results publications and other study-related documents

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