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Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation

केवल पंजीकृत उपयोगकर्ता ही लेखों का अनुवाद कर सकते हैं
साइन अप करने के लिए लॉग इन करें
लिंक क्लिपबोर्ड पर सहेजा गया है
स्थितिपूरा कर लिया है
प्रायोजक
Shaare Zedek Medical Center

कीवर्ड

सार

Gingivitis, defined as inflammation of the gingival tissues, has long been associated with bacterial accumulation [plaque] on the tooth surface adjacent to the gingiva, causing an inflammatory reaction. Experimental gingivitis in health adults can be induced by abstension from brushing teeth for 9 to 21 days, and can test the effects of numerous chemotherapeutic agents, rinses and toothpastes. Effective prevention of plaque accumulation can prevent destructive forms of periodontal disease.
A recent link has been established between localized gingival inflammation and systemic inflammation and a number of disease processes. Periodontal disease may lead to elevated C-reactive protein [CRP], considered a potential risk factor for cardiovascular disease and stroke. It has been shown that reducing gingival inflammation is accompanied with a significant decrease in serum CRP levels.
Naturopathic remedies for treating oral disease have been well documented in the medical and dental literature since early civilization, and have become more and more popular in recent years. We propose to study one such remedy, PERIORINSE. This remedy consists of a number of herbs, and has been shown to exhibit antibacterial and anti-inflammatory effects. Specifically, it has been shown to block the proteolytic effects seen in gingival inflammation . This study will evaluate the efficacy of this formulation, using currently accepted clinical testing protocols.
A Random sample of 100 healthy volunteers who fulfill all inclusion criteria and no exclusion criteria, will be included in the study. Patients will randomly selected to one of 4 treatment groups: PERIORINSE (n=25), CPC (Cepacol) mouthwash (25 patients), Listerine mouthwash (n=25), and placebo (colored water) mouthrinse. Patients will be examined at baseline, and Gingival Index taken for all teeth. A blood specimen will be taken to measure CRP levels as well. Patients will be given a full dental prophylaxis which includes scaling and tooth polishing, and given rinsing instructions and reminded to cease all other oral hygiene methods including brushing, flossing, and rinsing with any other rinse for a period of 14 days. On day 14, patients will be re-examined and Gingival Index taken for all teeth. Patients will be given a full dental prophylaxis which includes scaling and tooth polishing and required to reinstitute their original oral hygiene regimen. CRP levels will be measured again, as well.

खजूर

अंतिम सत्यापित: 06/30/2012
पहले प्रस्तुत किया गया: 04/19/2009
अनुमानित नामांकन प्रस्तुत किया गया: 04/20/2009
पहले पोस्ट किया गया: 04/21/2009
अंतिम अद्यतन प्रस्तुत किया: 07/15/2012
अंतिम अद्यतन पोस्ट: 07/16/2012
वास्तविक अध्ययन प्रारंभ दिनांक: 05/31/2009
अनुमानित प्राथमिक समापन तिथि: 05/31/2010
अनुमानित अध्ययन पूर्णता तिथि: 05/31/2010

स्थिति या रोग

Gingivitis

हस्तक्षेप / उपचार

Drug: PERIORINSE

Drug: CPC

Drug: Listerine

Drug: placebo

चरण

चरण 1/चरण 2

शाखा समूह

बांहहस्तक्षेप / उपचार
Experimental: PERIORINSE
naturopathic remedy
Drug: PERIORINSE
mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
Active Comparator: CPC
Cepacol, standard anti-bacterial mouthwash
Drug: CPC
mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
Active Comparator: Listerine
standard anti-bacterial mouthwash
Drug: Listerine
mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
Placebo Comparator: placebo
colored water
Drug: placebo
colored water mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

पात्रता मापदंड

युग अध्ययन के लिए पात्र 14 Years सेवा 14 Years
सेक्स अध्ययन के लिए पात्रAll
स्वस्थ स्वयंसेवकों को स्वीकार करता हैहाँ
मानदंड

Inclusion Criteria:

- Age 14-75.

- Clinical diagnosis of Gingivitis as measured by the Gingival index ≤ 0.5

- Healthy volunteer willing to cease all oral hygiene methods except for the mouthrinse for a period of three weeks.

- Have at least 24 teeth in their mouth

Exclusion Criteria:

- Pregnant or planning to become pregnant during the study period.

- Periodontal pockets greater than 5mm in 3 or more areas.

- History of periodontal treatment within the last month.

- Antibiotic treatment within the last month

- Use of any antimicrobial mouthrinse within the last month.

- Participation in another trial within one month prior to the study.

- Inability to comply with the trial protocol by not rinsing with mouthrinse 20% of time.

- Inability to comply, brushing the teeth or using another mouthrinse during the study period.

- Systemic Disease.

- On antibiotic or anti-inflammatory medication

- Cigarette-smoking

परिणाम

प्राथमिक परिणाम उपाय

1. Difference in the Gingival Index scores between the start and the end of the study [14 days]

माध्यमिक परिणाम उपाय

1. The difference in C-Reactive protein levels between the start and the end of the study. [14 days]

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