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Anti-inflammatory effect of an herbal mouthwash in periodontal patients

Not Applicable
Active, not recruiting
Conditions
periodontal disease
periodontal inflammation
Alternative and Complementary Medicine - Herbal remedies
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Registration Number
ACTRN12618001192279
Lead Sponsor
Istitutional funds from Prof. Putignano and Prof Orsini
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

Systemically healthy, minimum 20 teeth, smoker and no smoker, diagnosis of severe or moderate periodontitis

Exclusion Criteria

Use of antibiotics and anti-inflammatory drugs in previous 6 months, presence of orthodontic appliance, pregnant or lactating females, allergy to the mouthwash ingredients

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Differences in mean reduction of inflammation index.<br>Inflammation was measured by recording the bleeding index FMBS (Full Mouth Bleeding Score) on 6 dental surfaces of all teeth, using periodontal probes, according to the criteria of Ainamo and Bay (1975).[Baseline and 3 months post-intervention commencement ];Mouthwash safety was assessed using a questionnaire (specifically designed for this study) in which patients reported any adverse events, including redness of oral mucosa, mouth burning, desquamation, oral dryness, hard tissues brown spots, alteration of taste.<br>[Baseline and 3 months post-intervention commencement ]
Secondary Outcome Measures
NameTimeMethod
Difference in mean change of plaque accumulation index.<br>This was assessed using plaque index FMPS (Full Mouth Plaque Score), using plaque detectors, according to the criteria of O’Leary (1967).[Baseline and 3 months post-intervention commencement];Difference in mean change of probing depth level was assessed using periodontal probes.[Baseline and 3 months post-intervention commencement];Difference in mean change of clinical attachment level, using periodontal probes.[Baseline and 3 months post-intervention commencement]
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