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Evaluation of the effectiveness of mucoadhesive mouthwash containing propolis extract formulation on prevention and improvement of symptoms in patients with generalized chronic gingivitis

Protocol summary

Study aim
Determining the effect of propolis mouthwash on generalized chronic gingivitis
Design
Randomized clinical trial with two control groups, with parallel groups, double-blind, phase 2 on 78 patients using www.randomization.com for randomization.
Settings and conduct
We have three groups of 26 patients. For each patient, scaling is done first, then mouthwash is given, and we ask the patient to use mouthwash twice a day (10 cc/ turn) for 14 days. Indicators are measured twice, once before scaling and once at the end of day 14. Blinding is performed for the patient and the person examining the outcome. The study platform is Mashhad Dental School.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient does not have a systemic problem, Patient has generalized chronic gingivitis, Patient has filled out an informed consent form, Patient has no history of smoking Exclusion criteria: Pregnant patients, Patients who are unable to attend in follow up sessions, Patients receiving antibiotics systemically or topically, Breastfeeding patients, Using anti-inflammatory medications during the study, Using anti-coagulant medications during the study, Using immune-suppressive medications during the study, Patients receiving orthodontic therapy
Intervention groups
We have three groups, one group will receive mucoadhesive mouthwash of propolis (5%), and two control groups including placebo and chlorhexidine. We will ask the patient to use mouthwash twice a day (10 cc/ turn) for 14 days
Main outcome variables
Examination of plaque indices, BOP, gingival index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180130038558N1
Registration date: 2021-11-28, 1400/09/07
Registration timing: prospective

Last update: 2021-11-28, 1400/09/07
Update count: 0
Registration date
2021-11-28, 1400/09/07
Registrant information
Name
Naser Sargolzaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3602 5063
Email address
sargolzaien@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-01, 1400/09/10
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of mucoadhesive mouthwash containing propolis extract formulation on prevention and improvement of symptoms in patients with generalized chronic gingivitis
Public title
Effect of propolis on generalized chronic gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient does not have a systemic problem Patient has generalized chronic gingivitis Patient has filled out an informed consent form Patient has no history of smoking
Exclusion criteria:
Pregnant patients Patients who are unable to attend in follow up sessions Patients receiving antibiotics systemically or topically Breastfeeding patients Using anti-inflammatory medications during the study Using anti-coagulant medications during the study Using immune-suppressive medications during the study Patients receiving orthodontic therapy
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by block method, the size of blocks is equal to six with three members A and B and C in a ratio of 1: 1:1. Based on the sample size, 13 blocks are numbered in a different order from 1 to 13 and a random sequence of 13 blocks is determined using the site " http://www.randomization.com", then the sequence of treatment groups A and B and C is determined in envelopes with number 1 Up to 78, with the inclusion of each eligible person, the envelope corresponding to the person's number is opened and the treatment group is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the use of a placebo similar to the intervention treatment, the physician associated with the participants and participants will not be informed of the assigned treatment. Also, the analyst will be unaware of the treatment assigned to the three groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B and C. The placebo will be very similar in treatment in terms of shape, consistency, packaging, and smell.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2021-10-22, 1400/07/30
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1400.104

Health conditions studied

1

Description of health condition studied
Generalized Chronic Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis

Primary outcomes

1

Description
Examination of plaque indices
Timepoint
At the beginning of the study (before the start of the SRP) and 14 days later
Method of measurement
observation and check list of Turesky modification of the Quigley-Hein Plaque (MQH) Index

2

Description
Bleeding on probing (BoP)
Timepoint
At the beginning of the study (before the start of the SRP) and 14 days later
Method of measurement
observation and check list of Gingival bleeding index (GBI)

3

Description
Examination of gingival index
Timepoint
At the beginning of the study (before the start of the SRP) and 14 days later
Method of measurement
observation and check list of Modified Gingival Index (MGI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: mucoadhesive mouthwash with 5% propolis that every patient should use and rinse mouthwash for 30 seconds twice a day for 14 days and avoid eating and drinking for 30 minutes after use.
Category
Treatment - Drugs

2

Description
Control group: Cholorhexidin mouthwash that every patient should use and rinse mouthwash for 30 seconds twice a day for 14 days and avoid eating and drinking for 30 minutes after use.
Category
Treatment - Drugs

3

Description
Control group: Placebo mouthwash containing the base of propolis mouthwash that is the same as coloring, tasting, smelling and appearance. Every patient should use and rinse mouthwash for 30 seconds twice a day for 14 days and avoid eating and drinking for 30 minutes after use.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Dr. Nasser Sargolzaei
Street address
Vakil abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Email
sargolzaien@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayyur Mobarehan
Street address
University Street - next to Hoveyzeh Cinema - Ghorashi Building - Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Nasser Sargolzaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Periodontics
Street address
At the beginning of Vakilabad Boulevard, in front of Mellat Park - School of Dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Email
sargolzaen@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naser Sargolzaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
At the beginning of Vakilabad Boulevard, in front of Mellat Park - School of Dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Email
sargolzaien@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naser sargolzaie
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
At the beginning of Vakilabad Boulevard, in front of Mellat Park - School of Dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Email
sargolzaien@mums.ac.ir

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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