Generalized Gingivitis Clinical Trial
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).
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).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04662385 -
The Effect of Toothpaste Containing Aloe Vera on Gingivitis
|
Phase 2 |