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

NCT04328753 | Unknown Phase 1 DMC

• 1 other identifier: Baghdad University
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Generalized Gingivitis

Outcome Measures

Primary Outcomes (1)

• measuring interleukin -1 beta

  measure interleukin -1 beta in gingival crevicular fluid by using ELISA

  one week

Secondary Outcomes (3)

• measuring plaque accumulation

  one week

• measuring gingival inflammation

  one week

• measure the gingival sulcus erosion

  one week

Study Arms (3)

super oxidized water group

EXPERIMENTAL

Drug: Super Oxide water

chlorhexidene group

ACTIVE COMPARATOR

Drug: Chlorhexidine mouthwash

distilled water

PLACEBO COMPARATOR

Other: Distilled water

Interventions

Super Oxide water 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 .

Also known as: SOW

super oxidized water group

Chlorhexidine mouthwash 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

Also known as: CHX

chlorhexidene group

Distilled water OTHER

act as a negative control in this study

Also known as: D.W

distilled water

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: Forty-five adult male patients with generalized gingivitis
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. patient with generalized gingivitis. 2. no antibiotic treatment during a 3-month period prior to the start of the trial.
• \. no regular medication with anti-inflammatory compounds. 4. no history of allergy to oral care products. 5. no regular use of oral antiseptics.

You may not qualify if:

• \. Patients who refuse to write an informed consent form. 2. Smokers. 3. Female patients

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Baghdad university college of dentistry

Baghdad, +964, Iraq

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: third professional person give the one of opaque coded bottle to the participant
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist dentist

Model Details: 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).

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 31, 2020
• Study Start: April 1, 2020
• Primary Completion: May 20, 2020
• Study Completion: June 24, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)