The Effect of SOW Mouthwash on the Level of IL_1β in GCF and Some Clinical Periodontal Parameters for Patients With Gingivitis
Primary Purpose
Generalized Gingivitis
Status
Unknown status
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Super Oxide water
Chlorhexidine mouthwash
Distilled water
Sponsored by
About this trial
This is an interventional health services research trial for Generalized Gingivitis
Eligibility Criteria
Inclusion Criteria:
1. patient with generalized gingivitis. 2. no antibiotic treatment during a 3-month period prior to the start of the trial.
3. no regular medication with anti-inflammatory compounds. 4. no history of allergy to oral care products. 5. no regular use of oral antiseptics.
Exclusion Criteria:
- 1. Patients who refuse to write an informed consent form. 2. Smokers. 3. Female patients
Sites / Locations
- Baghdad university college of dentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
super oxidized water group
chlorhexidene group
distilled water
Arm Description
Outcomes
Primary Outcome Measures
measuring interleukin -1 beta
measure interleukin -1 beta in gingival crevicular fluid by using ELISA
Secondary Outcome Measures
measuring plaque accumulation
measure plaque accumulation on the teeth by measuring the plaque index using periodontal probe
measuring gingival inflammation
measure gingival inflammation by measuring the gingival index using periodontal probe
measure the gingival sulcus erosion
measure the gingival sulcus erosion and destruction by measuring the bleeding on probing index using periodontal probe
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04328753
Brief Title
The Effect of SOW Mouthwash on the Level of IL_1β in GCF and Some Clinical Periodontal Parameters for Patients With Gingivitis
Official Title
The Effect of Super Oxidized Water Mouthwash on the Level of IL_1β in Gingival Crevicular Fluid and Some Clinical Periodontal Parameters for Patients With Gingivitis: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
May 20, 2020 (Anticipated)
Study Completion Date
June 24, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Forty-five adult male patients with generalized gingivitis participated in the double blinded randomized controlled parallel study divided into three groups, two mouth rinses and distilled water( negative control) used during seven days periods as adjunctive to regular mechanical oral hygiene, one group received super oxidized water mouth rinses(microsafe®) three times daily and the second group received Alcohol-free chlorhexidine 0.12% solution(kin gingival®) twice dialy and the third group received distilled water (negative control).
The first visit included PLI measurement after that we removed the supra gingival plaque by cotton roll to avoid contamination with the periopaper strip during GCF collection, then GCF collected from targeted sites(upper incisors, labial side) after that the other clinical periodontal parameters ( GI and BOP) were measured and then scaling was done after sample collection because of gingival bleeding which occur during scaling then inform the patient to use the coded bottle which gave to the participant by the assistant not involve in the study so the researcher did not know the type of mouthwash that was given to the participant( CHX twice daily while SOW three times daily) .The mouthwashes was given for one week with routine mechanical dental home care(brushing and flossing).The codded bottle was gave randomly by a decision on that day for example on Sunday we gave all the participants code 1 and on other days we gave to other participants code 2 or code 3.
In the second visit the PLI was measured first , then the sample was collected from the same teeth after that the other periodontal parameters were collected again ( GI and BOP).
Detailed Description
One of the most predominant periodontal diseases is the plaque induced gingivitis. : For the past 20 years, super-oxidized solutions have been shown to be powerful antimicrobials and disinfectants via oxidative damage. The taste is better than chlorhexidine and doesn't stain the teeth. Some individuals experience a slight burning sense in the mouth when gargling. They should be taught to spit out the solution. The burning sensation then dispels. Microsafe®, a recently presented super-oxidized solution for gingival care, offers a completely improved approach to treatment of gingivitis. The neutral pH, super oxidized water was certified as an antiseptic in México in 2004. Animal tests were initially conducted to show that Microsafe® does not make irritation or sensitization in skin and mucosa. Interleukin 1 beta is one from interleukin family and it is released by many cells such as macrophage to control immune response.
Aims of the study
The aim of the study is to determine the effect of super oxidized water mouthwash on the pro inflammatory cytokines (IL_1β) in the gingival crevicular fluid and its effect on some clinical periodontal parameters (plaque index, gingival index and bleeding on probing index) compared to chlorhexidine in participants who continue to perform regular mechanical oral hygiene.
Objective To evaluate the efficacy of SOW on IL_1β by using ELISA technique Null hypothesis SOW has anti inflammatory effect by reducing IL_1β and some clinical periodontal parameters (plaque index, gingival index and bleeding on probing index) when used by the patients with regular mechanical oral hygiene.
Alternative hypothesis The effect of SOW mouth rinse(microsafe®) is less than Alcohol-free CHX 0.12% mouth rinse(kin gingival®) on the the inflammatory marker IL_1βand some clinical parameters (PI,GI and BOP).
Materials and methods
Forty-five adult male patients with generalized gingivitis participated in the double blinded randomized controlled parallel study divided into three groups, two mouth rinses and distilled water( negative control) used during seven days periods as adjunctive to regular mechanical oral hygiene, one group received super oxidized water mouth rinses(microsafe®) three times daily and the second group received Alcohol-free chlorhexidine 0.12% solution(kin gingival®) twice dialy and the third group received distilled water (negative control).
The first visit included PLI measurement after that we removed the supra gingival plaque by cotton roll to avoid contamination with the periopaper strip during GCF collection, then GCF collected from targeted sites(upper incisors, labial side) after that the other clinical periodontal parameters ( GI and BOP) were measured and then scaling was done after sample collection because of gingival bleeding which occur during scaling then inform the patient to use the coded bottle which gave to the participant by the assistant not involve in the study so the researcher did not know the type of mouthwash that was given to the participant( CHX twice daily while SOW three times daily) .The mouthwashes was given for one week with routine mechanical dental home care(brushing and flossing).The codded bottle was gave randomly by a decision on that day for example on Sunday we gave all the participants code 1 and on other days we gave to other participants code 2 or code 3.
In the second visit the PLI was measured first , then the sample was collected from the same teeth after that the other periodontal parameters were collected again ( GI and BOP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Gingivitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Forty-five adult male patients with generalized gingivitis participated in the double blinded randomized controlled parallel study divided into three groups, two mouth rinses and distilled water( negative control) used during seven days periods as adjunctive to regular mechanical oral hygiene, one group received super oxidized water mouth rinses(microsafe®) three times daily and the second group received Alcohol-free chlorhexidine 0.12% solution(kin gingival®) twice dialy and the third group received distilled water (negative control).
Masking
Outcomes Assessor
Masking Description
third professional person give the one of opaque coded bottle to the participant
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
super oxidized water group
Arm Type
Experimental
Arm Title
chlorhexidene group
Arm Type
Active Comparator
Arm Title
distilled water
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Super Oxide water
Other Intervention Name(s)
SOW
Intervention Description
Microsafe®, a recently available super-oxidized solution for gingival care, offers a completely improved approach for treatment of gingivitis. The neutral pH, super oxidized water was certified as an antiseptic .
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Other Intervention Name(s)
CHX
Intervention Description
CHX is a regular bisbiguanide artificial antiseptic containing of two biguanide groups and four chlorophenyl rings linked by a hexamethylene bridge. The dicationic nature of CHX makes it interacting strongly with anions, which is related to its safety, efficacy, and side effects. It is available in three forms, digluconate, acetate and hydrochloride salts. CHX has broad spectrum antimicrobial activity
Intervention Type
Other
Intervention Name(s)
Distilled water
Other Intervention Name(s)
D.W
Intervention Description
act as a negative control in this study
Primary Outcome Measure Information:
Title
measuring interleukin -1 beta
Description
measure interleukin -1 beta in gingival crevicular fluid by using ELISA
Time Frame
one week
Secondary Outcome Measure Information:
Title
measuring plaque accumulation
Description
measure plaque accumulation on the teeth by measuring the plaque index using periodontal probe
Time Frame
one week
Title
measuring gingival inflammation
Description
measure gingival inflammation by measuring the gingival index using periodontal probe
Time Frame
one week
Title
measure the gingival sulcus erosion
Description
measure the gingival sulcus erosion and destruction by measuring the bleeding on probing index using periodontal probe
Time Frame
one week
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Forty-five adult male patients with generalized gingivitis
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. patient with generalized gingivitis. 2. no antibiotic treatment during a 3-month period prior to the start of the trial.
3. no regular medication with anti-inflammatory compounds. 4. no history of allergy to oral care products. 5. no regular use of oral antiseptics.
Exclusion Criteria:
1. Patients who refuse to write an informed consent form. 2. Smokers. 3. Female patients
Facility Information:
Facility Name
Baghdad university college of dentistry
City
Baghdad
ZIP/Postal Code
+964
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Jawad Mohammed Ali, Higher Diploma
Phone
+9647719891780
Email
alijmohammedali0@gmail.com
First Name & Middle Initial & Last Name & Degree
Saif Sehaam Saliem, MSc
Phone
+9647901529484
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of SOW Mouthwash on the Level of IL_1β in GCF and Some Clinical Periodontal Parameters for Patients With Gingivitis
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