Protocol summary

Study aim
Fabrication and clinical study of the effect of lavender chewing gum on salivary Streptococcus mutans, salivary pH, plaque index, and gingival bleeding
Design
A clinical trial with the control group, with parallel groups, double-blind, randomized, with 57 participants. For randomization, sealed envelopes with predefined codes (code A: intervention and code B: control) that will be placed inside the bag will be used. Participants randomly select an envelope. After identifying the code, appropriate treatment is considered. The evaluator and the participant are not aware of any of the treatments.
Settings and conduct
Study of a double-blind, randomized (by random number table), with control and intervention group (lavender gum), on the staff of Tabriz University of Medical Sciences. Consume lavender gum for 2 weeks and then dental plaque and bacterial status of saliva will be checked. The evaluator and participant are not aware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion: Participants do not have systemic disease, Have acceptable oral hygiene (do not have a clear mass and plaque), Age range 18 to 65 years, People who have an average of 22 teeth, Do not be pregnant or breastfeeding Exclusion: Taking antibiotics or drugs that affect saliva, Use of an oral appliance, Smoking, and alcohol consumption, People with temporomandibular joint problem
Intervention groups
The staff of Tabriz University of Medical Sciences will be studied in two groups, the intervention (Chewing gum containing lavender extract) and the control (Chewing gum without lavender extract). The amount of chewing gum used by each person daily will be six pieces, one after each meal and three pieces during the day for at least 15 minutes for 14 consecutive days.
Main outcome variables
Plaque index and bleeding gums, number of Streptococcus mutans saliva colonies, saliva pH

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220122053799N1
Registration date: 2022-03-05, 1400/12/14
Registration timing: prospective

Last update: 2022-03-05, 1400/12/14
Update count: 0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Fatemeh Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 1996
Email address
mkoohsoltani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-06-04, 1401/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Fabrication and clinical study of the effect of lavender chewing gum on salivary Streptococcus mutans, salivary pH, plaque index, and gingival bleeding
Public title
Fabrication and evaluation of the effect of lavender gum in the mouth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants do not have systemic disease Have acceptable oral hygiene (no clear mass and plaque) Age range 18 to 65 years Do not be pregnant or breastfeeding Having an average of 22 teeth
Exclusion criteria:
Taking antibiotics or drugs that affect saliva Use oral appliance Smoking and alcohol consumption People with temporomandibular joint problems
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
The study will be conducted randomly among the staff of Tabriz University of Medical Sciences. The method of randomization is simple and its unit is individual. Randomization will be performed in such a way that the first group is identified by code A (intervention) and the second group by code B (control) and will be placed inside sealed envelopes; The envelopes are then placed in a bag and shaken. After returning to the place, people put their hands inside the bag and randomly take out an envelope. After viewing the code, the treatment will be given to the patient. The evaluator and participant are not aware of the type of groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is two-way blind and the outcome assessor, data analyst, and study participant are not aware of the type of groups. The researcher and outcome assessors are not aware of the randomization and segmentation of the Chewing gums among the participants and do not intervene. To blind the participants to the taste of chewing gum, the same flavoring is added to both types of chewing gum.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
No. 47, East 4th Floor, Mehdian Alley, Azari St., Valiasr Intersection, Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5167616775
Approval date
2022-01-12, 1400/10/22
Ethics committee reference number
IR.TBZMED.REC.1400.1003

Health conditions studied

1

Description of health condition studied
Dental caries
ICD-10 code
K02.3
ICD-10 code description
Arrested dental caries

Primary outcomes

1

Description
Gingival bleeding rate
Timepoint
Measure the percentage of plaque index at the beginning of the study (before the intervention) and 14 days after the start of chewing gum.
Method of measurement
Bleeding index using periodontal prop in Salcus at four levels (labial, Lingual and Interproximal)

2

Description
Check the percentage of license plate index
Timepoint
Measure the percentage of plaque index at the beginning of the study (before the intervention) and 14 days after the start of chewing gum.
Method of measurement
Plaque detector tablets

3

Description
Measurement of the number of Streptococcus mutans saliva colonies
Timepoint
Measure the percentage of plaque index at the beginning of the study (before the intervention) and 14 days after the start of chewing gum.
Method of measurement
The patient will be asked to collect saliva in the mouth for one minute and then pour it into a sterile Falcon graduated tube. To determine the number of Streptococcus mutans colonies, they should be sent to the microbiology laboratory and incubated in the specific medium of Mitis salivarius agar at 37 ° for 2 days and Streptococcus mutans were counted.

4

Description
Saliva pH
Timepoint
Measure the percentage of plaque index at the beginning of the study (before the intervention) and 14 days after the start of chewing gum.
Method of measurement
PH meter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Chewing lavender gum by extracting the plant by percolation method using 70% ethanol made in Tabriz Medical Research Center. The amount of gum used per person is six pieces of chewing gum daily, one after each meal and three pieces during The day will be for at least 15 minutes for 14 consecutive days.
Category
Treatment - Other

2

Description
Control group: Chewing gum without lavender extract, which is made in Tabriz Medical Research Center. The amount of chewing gum used by each person daily will be six pieces of chewing gum, one after each meal and three pieces during the day for at least 15 minutes for 14 consecutive days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Dental Hospital
Full name of responsible person
Fatemeh Safari
Street address
Dentistry Faculty of Tabriz, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
dent.fac@tbzmed.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Central office No. 2, Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Kooh Soltani
Position
Assistant Professor of oral and maxillofacial patholoy
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz, Daneshgah St., at the end of Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mkoohsoltani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Kooh Soltani
Position
Assistant Professor of oral and maxillofacial patholoy
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz, Daneshgah St., at the end of Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mkoohsoltani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Safari
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5167616775
Phone
+98 41 3329 1996
Email
fatemehsafari715@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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