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

NCT04328753 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-04-22

No results posted yet for this study

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

Interventions

DRUG

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 .

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

OTHER

Distilled water

act as a negative control in this study

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2020-05-20
Completion
2020-06-24

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04328753 on ClinicalTrials.gov