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

• Status: Recruiting
• Trial end date: 2020-06-24
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Baghdad
• Collaborator: Specialized Arab Hospital
• Treatments: Chlorhexidine

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