Protocol summary

Study aim
Suggesting regular periodontal examinations and receiving SRP if the improvement of the condition of chronic periodontitis is effective on disease activity in patients with ankylosing spondylitis and periodontitis.
Design
In this study, 2 control groups will receive oral hygiene instructions only, while 2 treatment groups will receive a non-surgical periodontal intervention including SRP. Periodontal indices will be done in 6 and 12 weeks after the intervention, and after 12 weeks, the BASDAI index will be measured to investigate the effect of non-surgical periodontal treatment on the inflammatory condition of ankylosing spondylitis on the control group.
Settings and conduct
This clinical trial study was conducted on 96 patients with active ankylosing spondylitis and moderate to severe generalized chronic periodontitis who were referred to a rheumatology center and were assigned to four groups (24 people in each group) using the random block method. be. which include two general case groups (periodontal treatment) and control (no periodontal treatment).
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 years or older, confirmed diagnosis of active AS, moderate to severe diffuse chronic periodontitis, patients with at least 20 teeth.Exclusion criteria: taking antibiotics in a period of 3 months before the study, receiving non-surgical periodontal treatment in the last 6 months, smoking, severe liver or kidney failure, uncontrolled diabetes, heart disease, history of radiation therapy or chemotherapy, taking drugs with Possible effect on periodontium , severe dry mouth, pregnancy and breastfeeding patients who do not come to measure the investigated variables in the 6th and 12th weeks.
Intervention groups
2 treatment groups will receive a non-surgical periodontal intervention including SRP.
Main outcome variables
Bath Ankylosing Spondylitis Disease Activity(BASDAI)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161106030744N3
Registration date: 2023-08-21, 1402/05/30
Registration timing: prospective

Last update: 2023-08-21, 1402/05/30
Update count: 0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Elham Fakhari
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3227 2253
Email address
dr.fakhari@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-02, 1402/06/11
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of non-surgical periodontal treatment on disease activity in patients with ankylosing spondylitis
Public title
Evaluation of the effect of non-surgical periodontal treatment on disease activity in patients with ankylosing spondylitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18 years of age or older Confirmed diagnosis of active AS by a rheumatologist Moderate to severe generalized chronic periodontitis Patients who have at least 20 teeth
Exclusion criteria:
Antibiotic use in a period of 3 months before the study Received non-surgical periodontal treatment in the last 6 months smoking Severe liver or kidney failure Uncontrolled diabetes Heart disease History of radiation therapy or chemotherapy Taking drugs with a possible effect on the periodontium (such as cyclosporine, phenytoin, calcium channel blockers) Severe dry mouth Pregnancy and breastfeeding Patients who do not return to measure the investigated variables in the sixth and twelfth weeks
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
First, random blocks of eight containing four letters A, B, C, D (each letter is repeated twice) are generated, such as ABBDCACD. Then, among these 8 blocks, 12 blocks are randomly selected and a sequence of 96 is created, and each letter is placed in a sealed envelope, numbered from 1 to 96. These envelopes, which contain one of the letters A, B, C, D, are delivered by the rheumatologist to the qualified people. Only the generator of the random sequence of 96 knows about the contents of the envelopes. Patients go to the dental clinic with the envelopes and hand over the envelopes to the periodontist. People who have the letter A will be assigned to the first group and the letter B will be assigned to the second group and so on.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Gorgan - Hirkan Boulevard - Central Organization of Golestan University of Medical Sciences and Healthcare Services
City
gorgan
Province
Golestan
Postal code
4918936316
Approval date
2023-07-29, 1402/05/07
Ethics committee reference number
IR.GOUMS.REC.1402.132

Health conditions studied

1

Description of health condition studied
Periodontal disease - ankylosing spondylitis
ICD-10 code
Z40-Z54
ICD-10 code description
افرادی که برای رویه ها و مراقبت های بهداشتی خاص با خدمات بهداشتی مواجه می شوند

Primary outcomes

1

Description
Bath Ankylosing Spondylitis Disease Activity(BASDAI)
Timepoint
0_ 12 weeks after the intervention
Method of measurement
The BASDAI consists of a 0-10 scale (0 being no problem and 10 being the worst problem) that is used to answer 6 questions related to the 5 main AS symptoms.

Secondary outcomes

1

Description
Periodontal indices (PI, GI, PPD, GBI, CAL)
Timepoint
0_ 6 weeks after the intervention_ 12 weeks after the intervention
Method of measurement
CAL: The distance from Cej to the apical depth of the probe is in millimeters. GBI: whether probing causes bleeding (+) or not (-) is assessed. PPD: the distance from the free margin of the gingiva to the bottom of the sulcus depth in millimeters. GI: ​​evaluation of the intensity and amount of gingival inflammation with BOP of the tooth. PI: It is based on the registration of soft debris and mineral deposits on the following teeth: upper right first molar, upper right lateral, upper left first premolar, lower left first molar, lower left lateral and lower right first premolar.

Intervention groups

1

Description
The first group: patients with AS and PD who take non-steroidal anti-inflammatory drugs (NSAID) who will receive non-surgical periodontal intervention including SRP. The second group: patients with AS and PD who take anti-tumor necrosis factor (TNF) drugs (with or without NSAID) who will receive non-surgical periodontal intervention including SRP
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The office of Dr. Mehrdad Aghaei, specialist in rheumatology
Full name of responsible person
دکترمهرداد آقایی
Street address
22 Adalat St., Valiasr St., 2nd floor, Saru building
City
gorgan
Province
Golestan
Postal code
4916631757
Phone
+98 17 3233 5574
Email
info@drmehrdadaghaei.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr.Narges Beigam Mirbehbahani
Street address
beginning of shast kola road
City
gorgan
Province
Golestan
Postal code
49341-74515
Phone
+98 17 3245 1660
Email
mirbeh@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
Dr Elham Fakhari
Position
assisstant professor Periodontics
Latest degree
Specialist
Other areas of specialty/work
Periodontics specialist
Street address
gorgan-in front of Edalat 97-dentistry clinic of golestan university of medical science
City
gorgan
Province
Golestan
Postal code
49169-53363
Phone
+98 17 3255 0700
Fax
+98 17 3255 0702
Email
Dr.fakhari@goums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Elham Fakhari
Position
assisstant professor Periodontics
Latest degree
Specialist
Other areas of specialty/work
Periodontics specialist
Street address
gorgan-in front of Edalat 97-dentistry clinic of golestan university of medical science
City
gorgan
Province
Golestan
Postal code
49169-53363
Phone
+98 17 3255 0700
Fax
+98 17 3255 0702
Email
Dr.fakhari@goums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Elham Fakhari
Position
assisstant professor Periodontics
Latest degree
Specialist
Other areas of specialty/work
Periodontics specialist
Street address
gorgan-in front of Edalat 97-dentistry clinic of golestan university of medical science
City
gorgan
Province
Golestan
Postal code
49169-53363
Phone
+98 17 3255 0700
Fax
+98 17 3255 0702
Email
Dr.fakhari@goums.ac.ir
Web page address

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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