Evaluation the effect of using ozonated water in non-surgical treatment of patients with chronic periodontitis
Design
Trial study(Phase 2) with parallel groups and design of a double-blind clinical trial design on 30 patients
Settings and conduct
This study is being done on patients referred to the periodontal department of Babol dental school. First, a clinician randomly divides the patients into two groups.Clinical parameters are measured by the second clinician (blind) and scaling is performed by the third clinician (blind).Parameter re-measurement is also performed by the second clinician.
Participants/Inclusion and exclusion criteria
Inclusion criteria: mild to moderate chronic periodontitis
Patient with o’leary plaque index equal or less than 20
Exclusion criteria:
Smoking
Intervention groups
The intervention group receives scaling and root planing (SRP) with ozonated-water. SRP includes full debridement of supragingival and subgingival plaque performed using a DTE D7 ultrasonic device. Full SRP is performed in two sessions of 40 minutes long each with a one-week interval in between the sessions. Each patient is followed up in four and eight weeks after the second treatment session. In each follow-up visit, the patient's clinical periodontal status is evaluated by periodontal pocket depth (PPD), clinical attachment level (CAL) and gingival index (GI).Patients in the control group receive scaling and root planing (SRP) with tap water(placebo).
Main outcome variables
Periodontal pocket depth (PPD); Clinical attachment loss (CAL); Gingival index (GI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090311001760N48
Registration date:2019-09-17, 1398/06/26
Registration timing:retrospective
Last update:2019-09-17, 1398/06/26
Update count:0
Registration date
2019-09-17, 1398/06/26
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-11, 1398/05/20
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of ozonated water in non-surgical patients with chronic periodontitis
Public title
Effect of ozonated water in scaling and root planing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Range age of 20-70 years
Mild to moderate chronic periodontitis
Patient with o’leary plaque index equal or less than 20
Exclusion criteria:
Smoking
Pregnancy and Lactation
Any types of systemic disease like hyperthyroidism, severe anemia, severe myasthenia, acute alcohol poisoning, recent myocardial infarction, active bleeding, etc.
Patients who received surgical or non-surgical or antibiotic therapies over the past 6 months.
People who should not use ultrasonic devices, including people who has infectious diseases and immune deficiency, those at risk of respiratory diseases.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization, randomization unit: individual, randomization tool: random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
The first clinician assigns patients randomly to control and intervention groups.
The second clinician which is blind toward the treatment, evaluates the clinical parameters.
Scaling and root planing procedures are performed by a third clinician, who is blind regarding whether ozonated water or tap water is being used.
The follow-up visits are performed by the second clinician, too.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrouz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2018-04-23, 1397/02/03
Ethics committee reference number
IR.MUBABOL.REC.1397.014
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
Periodontal pocket depth
Timepoint
baseline, 4 and 8 week after scaling and root planing (SRP)
Method of measurement
William's periodontal probe
2
Description
Clinical attachment loss
Timepoint
baseline, 4 and 8 week after SRP
Method of measurement
William's periodontal probe
3
Description
Gingival index
Timepoint
baseline, 4 and 8 week after SRP
Method of measurement
William's periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group receives scaling and root planing (SRP) with ozonated-water. SRP includes full debridement of supragingival and subgingival plaque performed using a DTE D7 ultrasonic device (Made in IR. Iran. by Ozonsazan Pasargad corporation. SS8 Ozone generator). Full SRP is performed in two sessions of 40 minutes long each with a one-week interval in between the sessions. The DTE D7 ultrasonic device consists of a water tank filled with ozonated-water. Based on the half-life of ozone molecules in water, the water tanks are refilled with fresh ozonated-water after 20 minutes. The maximum safe concentration of ozone in water, based on previous studies, is 8 ppm, and its proper concentration in different dentistry treatments, including periodontal non-surgical ones, 1.5 ppm. After the procedure, patients are instructed properly to adhere to oral and dental hygiene. Each patient is followed up in four and eight weeks after the second treatment session. In each follow-up visit, the patient's clinical periodontal status is evaluated by periodontal pocket depth (PPD), clinical attachment level (CAL) and gingival index (GI).
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group receive scaling and root planing (SRP) with tap water. SRP included full debridement of supragingival and subgingival plaque performed using a DTE D7 ultrasonic device. Full SRP is performed in two sessions of 40 minutes long each with a one-week interval in between the sessions. The DTE D7 ultrasonic device with a water tank that is filled with tap water. To ensure that the methods that are used for patients of the control group are seemingly equivocal to those of the intervention group, the water tank is refilled with tap water after 20 minutes, too.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Babol University of Medical Sciences
Full name of responsible person
Mojan Ghafouri
Street address
Babol University of Medical Sciences, Ganj Afrouz St
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9532
Email
ghafourimojan@gmail.com
Web page address
https://www.mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences, Ganj Afrouz St
City
Babol
Province
Mazandaran
Postal code
47176-47754
Phone
+98 11 3219 9592
Email
rezaghadimi@yahoo.com
Web page address
https://www.mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mojan Ghaforui
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Babol University of Medical Sciences, Ganj Afrouz St.
City
Babol
Province
Mazandaran
Postal code
47176-17745
Phone
+98 11 3219 9592
Email
ghafourimojan@gmail.com
Web page address
https://www.mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mohadese Yazdanpanah
Position
Periodontist/Assistant Professor of Faculty of Dentistry
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Babol University of Medical Sciences, Ganj Afrouz St.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
yazdanpanah.mohadese@com.yahoo
Web page address
https://dentistry.mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MA
Latest degree
Master
Other areas of specialty/work
Others
Street address
Babol University of Medical Sciences, Ganj Afrouz St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
0981132190578
Email
nghpasha@gmail.com
Web page address
https://www.mubabol.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