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Comparison of the effect of using chlorhexidine and Listerine mouthwash after Scaling and Root Planning(SRP) on Matrix metalloproteinase_8(MMP-8) salivary factor and periodontal indexes in gingivitis patients.

Protocol summary

Study aim
Investigating the use of mouthwash after SRP in the treatment of gingivitis and preventing its transformation into periodontitis
Design
The number of 45 patients in this clinical trial study with a control group and parallel groups without blinding, who referred to the periodontology department of Qom Dental School for scaling and root planning, were divided into 3 groups based on the entry and exit criteria by randomization using the 4 and 6 blocks method. they turn Group 1: 15 patients receiving ultrasonic SRP + Listerine mouthwash twice a day for ten days. Group 2: 15 patients receiving ultrasonic SRP + chlorhexidine mouthwash twice a day for ten days. Group 3: 15 patients who receive only ultrasonic SRP (without mouthwash)
Settings and conduct
Before and one month after performing dental interventions, the amount of bleeding on probing (BOP), pocket depth (PD), CAL, plaque index (PI), gingival index (GI) and salivary MMP-8 of all three groups of patients are measured.
Participants/Inclusion and exclusion criteria
Entry criteria: 1- age over 18 years, 2- clinical signs and symptoms of gingivitis such as calculus on the tooth surfaces, especially on the lingual surface of the anterior mandible and buccal surface of posterior maxilla, inflammation and bleeding gums on probing, 3- FMPI more than 20%. 4- FMBI more than 20 percent Exclusion criteria: 1- diabetes, 2- smoking, 3- corticosteroid use, 4- pregnancy and breastfeeding, 5- presence of periodontitis with probing depth more than 3 mm, 6- presence of periodontitis with CAL more than 2 mm in interproximal levels. , 7- Presence of implant, 8- Presence of composite veneer or laminate, 9- Presence of crown.
Intervention groups
Two of the three groups receive mouthwash. The control group does not receive any intervention
Main outcome variables
reducing plaque accumulation; tooth discoloration; Change in sense of taste

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240405061414N1
Registration date: 2024-08-08, 1403/05/18
Registration timing: prospective

Last update: 2024-08-08, 1403/05/18
Update count: 0
Registration date
2024-08-08, 1403/05/18
Registrant information
Name
Hossein Taghizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3886 0301
Email address
bendettahosein@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of using chlorhexidine and Listerine mouthwash after Scaling and Root Planning(SRP) on Matrix metalloproteinase_8(MMP-8) salivary factor and periodontal indexes in gingivitis patients.
Public title
Effect of Mouthwash after SRP on MMP-8 factor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Older than 18 years old Signs and Clinical symptoms of gingivitis Full mouth plaque index(FMPI) higher up 20 percent Full mouth bleeding index(FMBI) higher up 20 percent
Exclusion criteria:
Diabetes Cigarette Smoker Steroid User Pregnancy and lactation Present of periodontitis with probing depth(PD) upper than 3mm Present of periodontitis with Clinical attachment loss(CAL) upper than 2mm in proximal Present of implant Present of veneer and laminate Present of crown and pontic
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 45
More than 1 sample in each individual
Number of samples in each individual: 2
Before and one month later after SRP get salivary sample
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with block of six. In this way, by giving the number of samples to the output software, there are 8 groups of 6, which indicate for us in which group the first patient is, in which group the second patient is, and so on.
Blinding (investigator's opinion)
Double blinded
Blinding description
Bottles of mouthwashes and placebo are coded with the letters A, B and C, which no one except the researcher knows how to code.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of qom university of medical sciences
Street address
No. 96, Yadeghar Emam Blv, Shahid musavi St, Qom Town
City
Qom
Province
Ghoum
Postal code
3713874586
Approval date
2024-07-22, 1403/05/01
Ethics committee reference number
IR.MUQ.REC.1403.099

Health conditions studied

1

Description of health condition studied
Gingivitis
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases

Primary outcomes

1

Description
Level of MMP-8 salivary factor
Timepoint
Before and one month later dental procedure
Method of measurement
Eliza kite

Secondary outcomes

1

Description
Bleeding on probing
Timepoint
before and one month later dental procedure
Method of measurement
Bleeding Point Index

2

Description
Plaque Index
Timepoint
before and one month later dental procedure
Method of measurement
Leo and Silness index

3

Description
Gingival Index
Timepoint
before and one month later dental procedure
Method of measurement
Leo and Silness index

4

Description
Clinical attachment loss
Timepoint
before and one month later dental procedure
Method of measurement
The distance between the CEJ and the depth of the pocket was measured using a periodontal probe at six surface

5

Description
Probing depth
Timepoint
before and one month later dental procedure
Method of measurement
The distance from the gingival margin to the junctional epithelium was measured by the periodontal probe in these six levels

Intervention groups

1

Description
Intervention group:
Category
Treatment - Drugs

2

Description
Control group:
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical university of Qom
Full name of responsible person
Hossein Taghizadeh
Street address
No.96 Shahid Musavi street ، Yadeghare Emam blv ، Qom Town
City
Qom
Province
Ghoum
Postal code
3713874586
Phone
+98 25 3887 0301
Email
bendettahosein@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Taghizadeh
Street address
No.96 Shahid Musavi street ، Yadeghare Emam Blv ، Qom Town
City
Qom
Province
Ghoum
Postal code
3713874586
Phone
+98 25 3887 0301
Email
bendettahosein@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
50
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
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Taghizadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.96 Shahid Musavi street ، Yadeghare Emam blv ، Qom Town
City
Qom
Province
Ghoum
Postal code
3713874586
Phone
+98 25 3887 0301
Email
bendettahosein@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hosein Taghizadeh
Position
دانشجو
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.96 Shahid Musavi street ، Yadeghare Emam blv ، Qom Town
City
Qom
Province
Ghoum
Postal code
3713874586
Phone
+98 25 3887 0301
Email
bendettahosein@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Taghizade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.96 Shahid Musavi street ، Yadeghare Emam Blv ، Qom Town
City
Qom
Province
Ghoum
Postal code
3713874586
Phone
+98 25 3887 0301
Email
bendettahosein@gmal.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants data file-General study protocol-
When the data will become available and for how long
Immediately after printing the results-Clinical study report and code
To whom data/document is available
researchers
Under which criteria data/document could be used
research works
From where data/document is obtainable
09129386877
What processes are involved for a request to access data/document
Phone Number- Email- Fast
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