The main objective of the project: To determine the effect of non-surgical periodontal treatment on biochemical indicators of metabolic syndrome
Design
The study is an unblinded two arm parallel group randomized, controlled clinical trial.This study will be conducted on 54 patients. Patients will be divided into two intervention and control groups. The sealed envelope website will be used for randomization.
Settings and conduct
Patients with stage 1 and 2 periodontitis who were referred to Gorgan Dental School during the study will be included in the study if they are eligible and will be randomly assigned to two intervention and control groups using a randomized block design. Blinding is not possible in this study due to the nature of non-surgical periodontal treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The metabolic syndrome of the individuals participating in this study was confirmed by an endocrinologist, and these patients also had chronic periodontitis stages 1 and 2 and were referred to the Faculty of Dentistry for treatment.
Exclusion criteria: Having any disease affecting periodontal tissue except metabolic syndrome, having undergone periodontal treatments in the past 6 months.
Intervention groups
Intervention group:The treatment for this group will be health education and non-surgical periodontal treatment.This treatment will include plaque removal, plaque control, supra- and sub-gingival scaling, root planing all of which is done using a piezoelectric device.
Control group: in the control group, health education will be used, which will be in the form of teaching the correct frequency and method of brushing teeth and the correct use of dental floss.
Evaluation of the effect of non-surgical periodontal treatment on biochemical indicators of metabolic syndrome: A Controlled Randomized Clinical Trial
Public title
Evaluation of the effect of non-surgical periodontal treatment on biochemical indicators of metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 1st or 2nd Stage of periodontitis
Ages between 35 to 60
Definitive metabolic syndrome diagnosis in both groups
Having at least 20 teeth
Consent for participation
Exclusion criteria:
Having any kind of disease that could effect periodontal tissue other than matabolic syndrome like: Papillon-lefevre، Treacher Collins، Aggressive periodontitis، AIDS and End Stage Renal Disease
Taking any medication that could effect periodontal tissue such as: Nifedipine and Phenytoin
Using orthodontic treatments or fixed long span prostheses or removable prostheses
Taking Anti-biotics، Immunosuppressive drugs or Non-steroidal anti-inflammatory drugs for one week in last six month
Using periodontal treatment in last six month
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Patients would be randomized into two groups by Randomized block method with blocks of size 4. The website sealed envelope with https://sealedenvelope.com address will be used to prepare a random list of patients and this work is prepared by a project associate who has no role in treating patients.
To keep the random list hidden until the beginning of patients treatment, opaque and identical envelopes will be used. Each envelope will have the patient number written on it and the treatment the patient should receive. Given that in this study, the intervention will include scaling of the patients' teeth, there is no possibility of blinding the patient and the treating physician to the treatment the patient will receive, and the patient and the treating dentist are aware of the type of treatment the patients will receive.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Falsafi Higher Education Complex, The beginning of Shasat Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2025-04-20, 1404/01/31
Ethics committee reference number
IR.GOUMS.REC.1404.023
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
2
Description of health condition studied
Non-surgical periodontal treatment
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Fasting blood sugar factor value in blood test
Timepoint
Measuring the level of fasting blood sugar before the intervention and 3 and 6 months after the end of intervention.
Method of measurement
Glucometer
2
Description
Triglycerides factor value in blood test
Timepoint
Measuring the level of triglyceride before the intervention and 3 and 6 months after the end of intervention.
Method of measurement
Triglyceride Oxidase method
3
Description
Cholesterol factor value in blood test
Timepoint
Measuring the level of cholesterol before the intervention and 3 and 6 months after the end of intervention.
Method of measurement
Cholesterol Oxidase method
4
Description
HDL factor value in blood test
Timepoint
Measuring the level of HDL before the intervention and 3 and 6 months after the end of intervention.
Method of measurement
Enzymatic method
5
Description
Abdominal obesity in centimeters
Timepoint
Measuring the level of abdominal obesity before the intervention and 3 and 6 months after the end of intervention.
Method of measurement
Tape measure
6
Description
Blood pressure
Timepoint
Measuring Blood pressure before the intervention and 3 and 6 months after the end of intervention.
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
1
Description
Gingival recession
Timepoint
Measuring the amount of gingival recession before the intervention and 3 and 6 months after the end of the intervention
Method of measurement
Williams periodontal probe
2
Description
Clinical Attachment Loss
Timepoint
Measurement of clinical attachment loss before intervention and 3 and 6 months after the end of intervention.
Method of measurement
Williams periodontal probe
3
Description
Pocket probing depth
Timepoint
Measurement of pocket probe depth before intervention and 3 and 6 months after the end of intervention
Method of measurement
Williams periodontal probe
4
Description
Plaque index
Timepoint
Measurement of plaque index before intervention and 3 and 6 months after the end of intervention.
Method of measurement
Silness & Loe index
5
Description
Bleeding on probing
Timepoint
Measurement of bleeding on probing before the intervention and 3 and 6 months after the end of the intervention
Method of measurement
Williams periodontal probe
Intervention groups
1
Description
Intervention group:The intervention group treatment is built on oral health education and non-surgical periodontal therapy.The oral health educations content consists brushing techniques and frequency and flossing, which will be demonstrated to all patients in a one on one oral health instruction (OHI) session in dental school by a certified instructor which is the dentistry student who is in charge of the research. In the second step, treatment which is non-surgical periodontal therapy with a Woodpecker model:UDSL piezoelectric device will be delivered to the intervention group in a single session with no time limit.The treatment will contain plaque removal as a result of supra- and sub-gingival scaling,using the device mentioned prior in the text, Plaque control, root planing using a periodontal curette, and chemical agents such as Chlorhexidine mouthwash with 0.2% concentration as an adjunct. after that ,a monthly plaque control program will be executed by the operator on phone calls. patients will be clinically examined in 3 and 6 months afterwards and clinical periodontal parameters, fasting blood sugar, blood lipids, abdominal obesity and blood pressure will be assessed and compared to pre-treatment parameters.
Category
Treatment - Other
2
Description
Control group: In the control group, only oral health education will be used. The content of health education, including: the correct number and method of brushing and flossing, will be presented orally and individually to all patients in the control group at the beginning of the study in the dental school by the dental student implementing the project.Then, both the measurement of factors related to periodontal conditions and the measurement of metabolic syndrome factors will be performed by the dental student when the patient visits the dental school. After that, the monthly plaque control program is also followed up by the operator over the phone. Control group will be examined 3 months and 6 months later, and their clinical periodontal parameters, fasting blood sugar, blood lipids, abdominal obesity, and blood pressure will be examined and compared with before treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry faculty of Golestan University of Medical Sciences
Full name of responsible person
Amirreza Ahmadinia
Street address
Faculty of dentistry, Golestan University of Medical Sciences, 5th Shahriar, Shahriar town
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3262 7824
Email
ar.ahmadinia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Gholamreza Roshandel
Street address
Vice President for Research and Technology, Second Floor,Central Library Building, Falsafi Higher Education Complex, beginning of Shasat Kola Road
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
roshandel@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Amir reza Ahmadinia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Golestan University of Medical Sciences, 5th Shahriar, Shahriar town
City
Gorgan
Province
Golestan
Postal code
4916648679
Phone
+98 17 3253 6270
Fax
Email
ar.ahmadinia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Amir reza Ahmadinia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Golestan University of Medical Sciences, 5th Shahriar, Shahriar town
City
Gorgan
Province
Golestan
Postal code
4916648679
Phone
+98 17 3253 6270
Fax
Email
ar.ahmadinia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Amir reza Ahmadinia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Golestan University of Medical Sciences, 5th Shahriar, Shahriar town
City
Gorgan
Province
Golestan
Postal code
4916648679
Phone
+98 17 3253 6270
Fax
Email
ar.ahmadinia@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