Comparison of the effects of Chlorohexidine mouthwash 0/2% and alpha-pinen containing antiplaque mouthwash on periodontal index
Design
A randomized, blind, clinucal trial with parallel group design od 60 patients
Settings and conduct
This research is based on 60 people who refer to the periodontics department of the dental clinic of Kurdistan University of Medical Sciences. Patients are examined and all indicators are recorded. Then, the samples are carefully examined for supragingival calculus and the absence of periodontitis.
People are asked to use 15 cc of the mouthwash they received for two weeks twice a day for one minute.
Before using mouthwashes and two weeks later, people are examined and clinical indicators including plaque index, gingival index (Loe and Silness) and stain index (stain index by Loben method) will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: have at least 20 permanenr teeth, nonsmokers, being healthy, plaque index less than 2 , have gingivitis
Exclusion criteria: using antibiotics, dental prophilaxis during the last 3 months ,have 5 or more dental caries, pregnant or lactating women, taking anticoagulant drugs
Intervention groups
Patients will be randomly divided into three groups (A: chlorhexidine 0.2%; B: anti-plaque mouthwash containing alphapinen; C: control mouthwash (containing distilled water, aspartame and food coloring).
Main outcome variables
Plaque index ; gingival index ; stain index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220726055559N1
Registration date:2022-10-08, 1401/07/16
Registration timing:registered_while_recruiting
Last update:2022-10-08, 1401/07/16
Update count:0
Registration date
2022-10-08, 1401/07/16
Registrant information
Name
Shabnam Khalifehzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 2260
Email address
shabnam.kh63ii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2022-11-06, 1401/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Chlorohexidine mouthwash 0/2% and alpha-pinen containing antiplaque mouthwash on periodontal index
Public title
Effect of alpha-pinen containing qntiplaque mouthwash on periodontal index
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with at least 20 permanent teeth
Non-smoking patients
Being systematically healthy
Plaque indx > 2
Patients with gingivitis
Exclusion criteria:
Using topical or systemic antibiotics
Dental prophilaxis during the last 3 months
Patients with 5 or more dental caries require immediate restirative treatment
Pregnant or lactating women
Taking anticoagulant medications
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized block design is a type of experiment where participants who share certain characteristics are grouped together to form blocks, and then the treatment (or intervention) gets randomly assigned within each block. Each block has 20 participants and each block gets different mouthwash.
Blinding (investigator's opinion)
Double blinded
Blinding description
The mouthwash containing alphapinene and CHX 0.2% of the placebo mouthwash are poured into similar containers in order not to separate them due to their color and will be named with the letters a, b, c.
Patients who have the inclusion criterias will be selected. The nature of the procedure and possible complications and risks will be fully explained, and written informed consent will be obtained from each patient. Patients will be selected by systematic sampling and randomly divided into one of three groups (group A: chlorhexidine 0.2%; group B: anti-plaque mouthwash containing alphapinen; C: placebo mouthwash (containing distilled water, aspartame and food coloring). )
Participants and health personnel will be unaware of the type of mouthwash.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Science
Street address
Kurdistan University of Medical Science, Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
661713446
Approval date
2022-09-13, 1401/06/22
Ethics committee reference number
IR.MUK.REC.1401.208
Health conditions studied
1
Description of health condition studied
Generalized Gingivitis
ICD-10 code
K06.020
ICD-10 code description
Generalized gingival recession, unspecified
Primary outcomes
1
Description
Plaque index at first
Timepoint
14 days
Method of measurement
Clinical prrobing(silness and loe)
2
Description
Gingival index at first
Timepoint
14 days
Method of measurement
Clinical Probing(silness and loe)
3
Description
Stain index at first
Timepoint
14 days
Method of measurement
Clinical( loben method)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A this group will recieve Chlorohexidine 0/2% for 14 days. They will use it twice a day for about 2 mins.
Category
Treatment - Drugs
2
Description
Intervention group: B this group will recieve an alphapinen containing anti plaque mouthwash for 14 days. The will use it twice aday for about 2 mins.
Category
Treatment - Drugs
3
Description
Control group: C this group will recieve a placebo mouthwash containing: distilled water, aspartame, food colouring. They will use it for 14 days twice a week for about 2 min.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdistan University of Medical Science
Full name of responsible person
Elham Motallebi
Street address
Kurdistan University of Medical Science, Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
661713446
Phone
+98 87 3366 4643
Email
E.motallebi97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin maleki
Street address
Kurdistan University of Medical Science, Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
661713446
Phone
+98 87 3366 4643
Email
Maleki@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Elham Motallebi
Position
Dentisty student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 504, Razi 4 alley, Ghazi Ave, Vilashahr Town
City
Sanandaj
Province
Kurdistan
Postal code
6617774417
Phone
+98 87 3377 4526
Email
E.motallebi97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Shabnam Khalifezadeh
Position
Associate Profesosr
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 5, Shaghayegh Alley, Lotfi Ave, Shalman Blvs, Sanandaj City
City
Sanandaj
Province
Kurdistan
Postal code
6617975413
Phone
+98 87 3362 2260
Email
shabnam.kh63ii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Elham Motallebi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 504, Razi 4 alley, Ghazi Ave, Vilashahr Town
City
Sanandaj
Province
Kurdistan
Postal code
6617774417
Phone
+98 87 3377 4526
Email
E.motallebi97@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