MedPath

ayurvedic mouthwash to manage gum disease

Phase 3
Not yet recruiting
Conditions
Other bacterial infections of unspecified site,
Registration Number
CTRI/2019/10/021574
Lead Sponsor
Ceego Lab Pvt Ltd Chennai
Brief Summary

The aim of the study is to evaluate the efficacy of an herbal mouthwash in the Management of Chronic Periodontitis in comparison with chlorhexidine mouthwash. 120 patients with chronic periodontitis will be selected and they will be randomly divided into 4 groups. Detailed periodontal examination will be done in all the patients followed by scaling and rootplaning. Group I will be instructed to use liquid form of herbal mouthwash,  Group II will be instructed to use 30g active ingredient of drug in powder form diisolved in water ,  Group III will be instructed to use 50 g whole extract of herbal drug dissolved in water and  Group IV will be instructed to use chlorhexidine mouthwash, which is considered as the gold standard mouthwash. Herbal drug in liquid and powder form will be prepared by Ceego Labs Pvt. Ltd, Chennai according to the composition described in patent (United States patent application US 13/883,551. 2013 Sep 19). the application of mouthwash is recommended twice daily for 2 weeks.  Reevaluation will be done after 2 weeks to evaluate the efficacy of the mouthwash in reducing gingival inflammation and plaque accumulation.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
120
Inclusion Criteria
  • •Systemically healthy patients diagnosed with chronic generalized periodontitis.
  • •Presence of gingival inflammation, GI≥ 2 •≥ 20naturalteeth •Probing depth (PD) ≥ 5mm in> 30 % of sites •CAL ≥ 3mm in> 30% of sites •Radiographic evidence of generalized alveolar bone loss>50% •Those willing to participate in the study.
Exclusion Criteria

Patients with systemic diseases or other conditions that could influence the periodontal status 2.Patients who are currently under any medication and who have taken antibiotics or anti-inflammatory drugs for the past 3 months 3.orthodontic devices, extended prosthetic ï¬xed devices, removable partial dentures, or overhanging restorations 4.regular use of chemotherapeutic antiplaque/anti gingivitis products 5.periodontal treatment performed within 6 months before study initiation 6.Pregnant and lactating females 7.Aggressive periodontitis 8.Current smokers.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
change in bleeding on probingbaseline and 2 weeks after scaling and root debridement
Secondary Outcome Measures
NameTimeMethod
plaque accumulationbaseline and 2 weeks after scaling and root debridement
pocket depth reductionbaseline and 2 weeks after scaling and root debridement

Trial Locations

Locations (1)

PMS College of Dental Science and Research

🇮🇳

Thiruvananthapuram, KERALA, India

PMS College of Dental Science and Research
🇮🇳Thiruvananthapuram, KERALA, India
Dr AmbiliR
Principal investigator
9447463676
ambiliranjith@yahoo.com

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