Generalized GingivitisPhase 1/2NCT04328753
The Effect of SOW Mouthwash on the Level of IL_1β in GCF and Some Clinical Periodontal Parameters for Patients With Gingivitis
A Phase 1/2 study testing Super Oxide water, Chlorhexidine mouthwash and Distilled water in people with Generalized Gingivitis, run by University of Baghdad at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Generalized Gingivitis
- What is being tested?
- Super Oxide water, Chlorhexidine mouthwash and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIraq
- Study dates
- 1 Apr 2020to 24 Jun 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 1. Patients who refuse to write an informed consent form. 2. Smokers. 3. Female patients
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Baghdad university college of dentistry
Baghdad, +964
Ali Jawad Mohammed Ali, Higher Diploma, +9647719891780, alijmohammedali0@gmail.com
Saif Sehaam Saliem, MSc, +9647901529484
About this study
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
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).
Read the 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).
- Conditions
- Generalized Gingivitis
- Being tested
- Super Oxide water, Chlorhexidine mouthwash, Distilled water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Oxide waterDrug
Also called SOW
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 .
Chlorhexidine mouthwashDrug
Also called CHX
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
Distilled waterOther
Also called D.W
act as a negative control in this study
| Study group | Role | What they receive |
|---|---|---|
| super oxidized water group | Experimental | Not described Receives: Drug: Super Oxide water |
| chlorhexidene group | Active comparator | Not described Receives: Drug: Chlorhexidine mouthwash |
| distilled water | Placebo comparator | Not described Receives: Other: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring interleukin -1 beta
measure interleukin -1 beta in gingival crevicular fluid by using ELISA
Measured: one week
Secondary outcomes (3)
measuring plaque accumulation
measure plaque accumulation on the teeth by measuring the plaque index using periodontal probe
Measured: one week
measuring gingival inflammation
measure gingival inflammation by measuring the gingival index using periodontal probe
Measured: one week
measure the gingival sulcus erosion
measure the gingival sulcus erosion and destruction by measuring the bleeding on probing index using periodontal probe
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Apr 2020
- Primary completion20 May 2020 (estimated)
- Study completion24 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized GingivitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Jawad, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328753
- Sponsor's protocol ID
- Baghdad University
- Status last verified
- Apr 2020
- First submitted
- 24 Mar 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04328753
- Acronym / sponsor ID
- Baghdad University
- Conditions
- Generalized Gingivitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 24 Jun 2020 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| super oxidized water group | Experimental | Drug: Super Oxide water |
| chlorhexidene group | Active comparator | Drug: Chlorhexidine mouthwash |
| distilled water | Placebo comparator | Other: Distilled water |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Patients who refuse to write an informed consent form. 2. Smokers. 3. Female patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super Oxide waterAlso: SOWMicrosafe®, 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 . | Drug | super oxidized water group |
| Chlorhexidine mouthwashAlso: CHXCHX 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 | Drug | chlorhexidene group |
| Distilled waterAlso: D.Wact as a negative control in this study | Other | distilled water |
Primary outcome
measuring interleukin -1 beta
Time frame: one week
measure interleukin -1 beta in gingival crevicular fluid by using ELISA
3 secondary outcomes
measuring plaque accumulation
Time frame: one week
measuring gingival inflammation
Time frame: one week
measure the gingival sulcus erosion
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Super Oxide water, Chlorhexidine mouthwash and Distilled water in people with Generalized Gingivitis, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring interleukin -1 beta (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.