Comparing the effect of a herbal mouthwash and chlorhexidine mouthwash on the inflammation of gums.

Not Applicable

Completed

• Conditions: plaque induced gingivitis

• Registration Number: CTRI/2018/02/011675
• Lead Sponsor: Shweta Sharda

Brief Summary

**Background and Aim:** Use of mouthwashes as an adjunct in the daily oralhygiene regimen has been strongly recommended by the dentists worldwide.Chlorhexidine has in fact been proven to be a gold standard in mouthwashes andis known to significantly reduce/prevent gingivitis. But owing to itsside-effects of tooth discoloration and transient taste alteration on its longterm use, there has been a constant effort to discover an equally efficientmouthwash with minimal or no side-effects. The aim of this study was toevaluate the effectiveness of a commercially available herbal mouthwash(Himalaya HiOra Regular) in comparison to 0.12% Chlorhexidine mouthwash inreducing gingivitis and salivary neutrophil count.

**Methods and Materials:** This study was a double blinded, randomized design.The herbal mouthwash (Himalaya HiOra Regular) was compared to 0.12%Chlorhexidine mouthwash (positive control).The patients gingival health statuswas evaluated using Gingival Index and Salivary Neutrophil Count (usingFluorescent Microscope) at baseline visit, 15th day and 30thday of intervention.

**Results:** Outof the 36 subjects randomized, none were lost to follow up and a total of  18 were analysed in Group A(Himalaya HiOraRegular Mouthwash) and 18 in Group B(0.12% Chlorhexidine). Both the groupsshowed a statistically significant reduction in Gingival Index Score ( Group A - 17%   & Group B - 14%   ) and in Salivary Neutrophil Counts (GroupA -  35%  & Group B -32%). There was no significant difference inbetween the two groups both in the Gingival Scores ( ) and in the salivaryneutrophil counts (  ).

**Conclusions:** Thisstudy has shown that herbal mouthwash is at par with the gold standard  in reducing gingivitis in a 4 week period.Thus herbal mouthwash forms a promising adjunct to the daily oral hygieneregimen with minimal/ no side effects reported.

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-09-29
• Study Start: 2016-12-08
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 1.A minimum of 20 sound natural teeth with scorable facial and lingual surfaces.
• 2.Willingness to read, understand and sign the informed consent form.
• 3.Male and female subjects between 18-50 years in good general health.
• 4.Subject with good periodontal health with pockets < 6mm.
• 5.A gingival index score of ≥1.0. 6.A plaque index score of ≥1.5. 7.Availability for the entire study duration.

Exclusion Criteria

• 1.Destructive periodontal disease.
• 2.Significant soft tissue pathology, systemically related gingival enlargement / severe gingivitis.
• 3.History of diabetes, hepatic, renal disease or other serious medical condition and transmissible disease.
• 4.Orthodontic appliance or any kind of fixed or removable appliances.
• Materials & Methods 5.History of allergies to dental products or their ingredients.
• 6.Pregnant and breast feeding women.
• 7.History of adverse habits like smoking and tobacco chewing.
• 8.Undergoing antibiotic, steroid therapy or any anti-inflammatory drugs in the preceding month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gingivitis - measured by Modified Loe and Silness Gingival index	15th day and 30th day post intervention

Secondary Outcome Measures

Name	Time	Method
Salivary Neutrophil Count	15th day and 30th day post intervention

Trial Locations

Locations (1)

SDMCDSH, Dharwad; 🇮🇳 Dharwad, KARNATAKA, India

SDMCDSH, Dharwad

🇮🇳Dharwad, KARNATAKA, India

Shweta Sharda

Principal investigator

9731278744

shwetasharda1989@gmail.com