The Effect of SOW Mouthwash on the Level of IL_1β in GCF and Some Clinical Periodontal Parameters for Patients With Gingivitis

NCT ID: NCT04328753

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2020-06-24

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).

Conditions

Generalized Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

super oxidized water group

Group Type: EXPERIMENTAL

Super Oxide water

Intervention Type: DRUG

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 .

chlorhexidene group

Group Type: ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type: DRUG

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 water

Group Type: PLACEBO_COMPARATOR

Distilled water

Intervention Type: OTHER

act as a negative control in this study

Interventions

Super Oxide water

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

Chlorhexidine mouthwash

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: DRUG

Distilled water

act as a negative control in this study

Intervention Type: OTHER

Other Intervention Names

SOW; CHX; D.W

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Ali Jawad

Specialist dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baghdad university college of dentistry

Baghdad, , Iraq

Site Status: RECRUITING

Countries

Iraq

Facility Contacts

Ali Jawad Mohammed Ali, Higher Diploma

Role: primary

alijmohammedali0@gmail.com

+9647719891780

Saif Sehaam Saliem, MSc

Role: backup

+9647901529484

Other Identifiers

Baghdad University

Identifier Type: -

Identifier Source: org_study_id