Evaluation of the safety and the efficacy of a novel polyherbal mouthwash containing Emblica officinalis,Cinnamomum cassia,Silicate of magnesia,Nigella sativa and Eucalyptus globulus oil in patients with gingivitis:A randomized controlled trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- 1)DECREASE IN SALIVARY CRP LEVEL
Study Overview
Brief Summary
Periodontal diseases have adestructive effect on the supporting tooth tissues. The mildest form of thesediseases is gingivitis which is characterized by bleeding, plaque
formation andgum inflammation .Several lines of evidence haveshown that elimination of microbial dental plaque biofilm prevents gingivitis. In addition to mechanical oral
hygiene approaches, there is a need for additional measures to controlbacterial plaque formation by using antimicrobial dentifrices or anti-plaque
mouthwashes. Chlorhexidine, a bisguanideis considered benchmark of antimicrobial rinses due to its high substantivityand wide range of activity. Chlorhexidine is not a
‘Miraculous solution’ as it hasdefinite after effects like taste alteration, mucosal irritation, dry mouth,tooth discoloration, cytotoxic effect.Based on the ill-effects of
chlorhexidine, World Health Organization admonishedresearchers to probe the potential of herbs and plant extracts. Hence, finding newer antiplaqueand
antimicrobial agents with a natural origin is important to increasetreatment compliance and reduce adverse effects upon long-term application. In dentistry,
Herbal concentrateswere used to lessen inflammation, prevent dental caries, to heal gingivitis& periodontitis, and as antimicrobials & antioxidants. The
natural products used in thisstudy were Indian gooseberry (Emblica Officinalis), cinnamon(Cinnamomum Cassia), HydratedMagnesium silicate(silicate of
magnesia), Black seed(Nigella Sativa),Eucalyptus oil(Eucalyptus Globulus) .Theefficacy of all the substances were proven individually. The combined effect of
the substances was not studied previously . Thus the aim of the study was toevaluate the clinical safety and efficacy of polyherbal mouthwash containing Indian
gooseberry, Cinnamon, Hydrated magnesium silicate, black seed And Eucalyptus oil against commerciallyavailable chlorhexidine mouthwash.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •APPARENTLY HEALTHY INDIVIDUALS WITH PRESENCE OF ATLEAST 20 NATURAL TEETH DIAGNOSIS OF GINGIVITIS-DENTAL BIOFILM INDUCED.
Exclusion Criteria
- •PREGNANCY AND LACTATION 2)DECOMPENSATED SYSTEMIC DISEASE 3)DEGENERATIVE BONE DISEASE 4)SJOGREN SYNDROME 5)ADVANCED PERIODONTAL OR ORTHODONTIC DISEASE 6)HISTORY OF ORAL PROPHYLAXIS WITHIN 6 MONTHS 7)HISTORY OF TAKING ANTIBIOTICS,ANTICOAGULANT,IMMUNOSUPPRESSIVE,ANTI-INFLAMMATORY MEDICATION OR USING ANTI-BACTERIAL MOUTH RINSES FOR PAST 6 MONTHS.
- •SMOKING,DRUG AND ALCOHOL ABUSE.
Outcomes
Primary Outcomes
1)DECREASE IN SALIVARY CRP LEVEL
Time Frame: three months
2)DECREASE IN GINGIVAL INDEX,GINGIVAL BLEEDING INDEX,PLAQUE INDEX
Time Frame: three months
Secondary Outcomes
- effectiveness of polyherbal mouth wash(three months)