Protocol summary

Study aim
The aim of this study is to determine the effect of metformin gel in the treatment of acute severe periodontitis and compare with control group.
Design
Clinical trial with control group, double-blind, randomized
Settings and conduct
Patients referred to the Periodontitis Department of Zahedan School of Dentistry, who have been diagnosed with severe chronic periodontitis a questionnaire containing patient information and inflammatory criteria will be completed by the project manager. Then scaling will be performed for patients and health education for brushing and flossing will be fully explained to all patients. Patients are then referred to the secretary. They randomly select and open one of the 50 closed envelopes, this choice can be metformin gel or placebo. After probing the patient, 3 locations with a CAL greater than 5 mm were selected and the depth of the probe and the CAL are recorded. Then in the selected locations, 10 ml of the drug (metformin gel or placebo) are placed using a Canola needle. The volunteer is then advised to with full caution brush and floss for up to a week in places where medicine is placed. Candidates will be re-called after 3 weeks and 2 months. In the summons, the depth of the probe and the CAL are measured at the drug sites. Then according to the group in which the candidate is located, metformin gel or placebo is applied again to the affected areas. 4 months after the start of the study, in the third session of the call the previous measurements are performed again. The data collected at the beginning of treatment and call sessions are analyzed by statistical methods.
Participants/Inclusion and exclusion criteria
The study included 48 patients diagnosed with severe chronic periodontitis. Patient consent will be obtained from patients.
Intervention groups
Group A metformin gel 1% Group B placebo
Main outcome variables
clinical attachment lost

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200623047900N1
Registration date: 2020-06-29, 1399/04/09
Registration timing: prospective

Last update: 2020-06-29, 1399/04/09
Update count: 0
Registration date
2020-06-29, 1399/04/09
Registrant information
Name
Mohamad Hosein Foroutani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 4004
Email address
mh.forootani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-08-10, 1399/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of metformin gel in patients with severe chronic periodontitis and control group
Public title
Investigation of the effect of metformin gel on severe chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious consent of the patient to participate in the research The depth of the periodontal pocket is greater than or equal to 5 mm Do not consume alcohol and any tobacco Do not take antibiotics for three months before the visit No history of periodontal treatment 6 months before referral Non-consumption of systemic metformin Lack of any systemic disease that is effective in a person's periodontal condition. Not being pregnant or breastfeeding
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is used and 50 closed envelopes are prepared. People randomly select one and open it. Out of 50 envelopes, 25 envelopes will be allocated to Group A placebo and 25 envelopes to Group B 1% metformin gel.
Blinding (investigator's opinion)
Double blinded
Blinding description
Envelopes containing drug codes are kept with the secretary and medicines containing metformin gels and placebo are packaged in similar containers and in groups (A) and (B) are named and coded. The codes for each container are unknown to the patient, the researcher (student) and they will be kept confidential by the supervisor until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hesabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-05-10, 1399/02/21
Ethics committee reference number
IR.ZAUMS.REC.1399.089

Health conditions studied

1

Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
Clinical attachment loss
Timepoint
After 3 weeks, 2 months and 4 months after placing the drug deep in the Periodontal pocket
Method of measurement
Through a clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Use of 1% metformin gel
Category
Treatment - Drugs

2

Description
Control group: Using a placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahedan School of Dentistry, Department of Periodontology
Full name of responsible person
Mohamad Hosein Foroutni
Street address
Azadegan east St., Zahedan Dental School
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Fax
+98 54 3241 4003
Email
mh.forootani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohamad Hosein Foroutani
Street address
East Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Email
mh.forootani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Sanaz Isar
Position
Bachelor, Research Expert
Latest degree
Bachelor
Other areas of specialty/work
Library and Medical Information
Street address
East Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3341 5705
Email
Arbabi.Parvin@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Parvin Arbabi Kalati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
East Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Email
arbabi.parvin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohamad Hosein Foroutani
Position
Dentistry student
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
East Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Email
mh.forootani@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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