Protocol summary

Study aim
Determining the effect of chlorhexidine, Persica and Protact mouthwashes on gingival healing after crown lengthening surgery
Design
A randomized clinical trial in the form of a randomized block with a control group, with parallel groups, double-blind on 33 patients. Choosing the type of group for each person through random allocation software 2
Settings and conduct
The study will be conducted on patients referred to Sari Dental Faculty who are candidates for tooth crown lengthening surgery. The study is double-blind and to blind the patients and the surgeon (researcher), the mouthwashes will be placed in the same dark bottles with different labels. Patients will use mouthwash for 2 weeks from the night of surgery, and then the variables will be checked and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients between 18 and 60 years old with indication of crown lengthening surgery Exclusion criteria: systemic disease, smokers, pregnant and breastfeeding women, being allergic to mouthwashes, using antibiotics in the last 3 months for 10 consecutive days, using drugs that interfere with gum healing and corticosteroids,
Intervention groups
Patients will be divided into three groups. Each group will be given one of chlorhexidine 0.2%, Persica and Protact mouthwashes. the patients will be asked to use mouthwashes for two weeks from the night of surgery according to the manufacturer's recommendations, and avoid washing their mouths, eating and drinking for half an hour after using the mouthwash. After surgery, all patients will be prescribed ibuprofen 400mg.
Main outcome variables
mouthwash taste through questionnaire and gingival index; Plaque index; Stain index and tongue color change are checked and recorded by the periodontist

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170502033770N2
Registration date: 2023-06-11, 1402/03/21
Registration timing: registered_while_recruiting

Last update: 2023-06-11, 1402/03/21
Update count: 0
Registration date
2023-06-11, 1402/03/21
Registrant information
Name
Hodis Ehsani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 4135
Email address
hehsani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of chlorhexidine, Persica and Protact mouthwash on gingival healing after crown lengthening surgery: a double-blinded randomized clinical trial
Public title
The effect of Persica and Protact herbal mouthwashes on the wound of gum surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be between 18 and 60. Patients with indications for clinical crown lengthening surgery on at least one tooth. Patients agree to participate in the study.
Exclusion criteria:
They have used antibiotics for 10 consecutive days in the past 3 months. They are allergic to mouthwash. Patients have diabetes or any other systemic disease. Patients take medications that interfere with gum healing, such as contraceptives. They use corticosteroids. They are pregnant or breastfeeding. They use cigarettes. They have pathological lesions in the oral mucosa. They have removable dental prostheses or orthodontics. They have periodontitis in the surgical area. The teeth are discolored due to systemic factors or drugs.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method will be used to assign samples to groups (type of mouthwash). First, the samples will be matched in terms of age, gender, periodontium condition and oral hygiene and people with similar status will be placed in a block. According to the total number of required samples (33 samples) and the number of mouthwashes, finally 11 blocks with matched samples will be considered as 3 samples in each block (number of mouthwashes). Selection of blocks and type of mouthwash for each sample will be done through random allocation software 2 and the samples will be placed in one of the groups by this software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. In order to blind patients, therapists and researchers, mouthwashes are placed in dark-colored bottles with the same appearance with different labels and are prescribed along with painkillers. According to the recommendations of the manufacturers, the mouthwash instructions leaflet is given to the patients in identical envelopes with different labels according to the mouthwash label, and the patients are asked to use the relevant mouthwash according to the leaflet.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Khazar Blvd, Sari Faculty of Dentistry (Tooba dental clinic)
City
Sari
Province
Mazandaran
Postal code
4816895475
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.MAZUMS.REC.1401.491

Health conditions studied

1

Description of health condition studied
Clinical dental crown lengthening surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
gingival index (GI)
Timepoint
Measurement of gingival index on the day of surgery and 14 days after surgery
Method of measurement
by periodontal probe

2

Description
plaque index (PI)
Timepoint
Measurement of plaque index on the day of surgery and 14 days after surgery
Method of measurement
by dental explorer

Secondary outcomes

1

Description
Stain index (SI)
Timepoint
14 days after surgery
Method of measurement
by periodontal probe

2

Description
Changing the color of the tongue
Timepoint
14 days after surgery
Method of measurement
observation

3

Description
taste of the mouthwash
Timepoint
14 days after surgery
Method of measurement
questionnaire

Intervention groups

1

Description
Control group: This group will be given Chlorhexidine 0.2% mouthwash (Iran Najo Company) and they will be asked to use 10 ml of mouthwash and swish it in their mouth for 30 seconds twice a day in the morning and at night after brushing teeth according to the manufacturer's recommendation for two weeks from the night of surgery. Patients will be asked to avoid washing their mouth, eating and drinking for half an hour after using the mouthwash. Also, after surgery, all patients will be prescribed ibuprofen 400mg
Category
Treatment - Drugs

2

Description
Intervention group: This group (the first intervention group) will be given Persica mouthwash (Porsina company) and they will be asked to dilute 15 drops of mouthwash with 15 ml of water and swish it in their mouth for 20 seconds 4 times a day according to the manufacturer's recommendation for two weeks from the night of surgery. Patients will be asked to avoid washing their mouth, eating and drinking for half an hour after using the mouthwash. Also, after surgery, all patients will be prescribed ibuprofen 400mg.
Category
Treatment - Drugs

3

Description
Intervention group: This group (the second intervention group) will be given Protact mouthwash (Zolangrespina company) and they will be asked to use 5 ml of mouthwash and swish it in their mouth for 1 minute 3 times a day (after breakfast, lunch and at night after brushing teeth) according to the manufacturer's recommendation for two weeks from the night of surgery. Patients will be asked to avoid washing their mouth, eating and drinking for half an hour after using the mouthwash. Also, after surgery, all patients will be prescribed ibuprofen 400mg.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sari Faculty of Dentistry
Full name of responsible person
Hadis Ehsani
Street address
Khazar Blvd, Sari Faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
hehsani@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hadis Ehsani
Street address
Khazar Blvd, Sari Faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
hehsani@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
حدیث احسانی
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd, Sari Faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
hehsani@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hadis Ehsani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd, Sari Faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
hehsani@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hadis Ehsani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd, Sari Faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
hehsani@mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
After the completion of the project, the results will be delivered in the form of a final report and in electronic form (on a CD) to the Vice-Chancellor of Research and Faculty of Dentistry of Mazandaran University of Medical Sciences.
When the data will become available and for how long
The decision regarding access to the data will be the responsibility of the vice president of research and the Faculty of Dentistry of Mazandaran University of Medical Sciences, as well as the supervisor.
To whom data/document is available
Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor
Under which criteria data/document could be used
The request should be sent to the responsible person after consultation with the research team, the data will be provided to the requesting person, and it is necessary to give reference to the data owners in the articles or wherever the data is to be used, and the use of the results only It is allowed by citing its source.
From where data/document is obtainable
Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor
What processes are involved for a request to access data/document
A written request to the vice president of research or the Faculty of Dentistry of Mazandaran University of Medical Sciences and also obtaining the consent of the supervisor.
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