Health Condition 1: B957- Other staphylococcus as the causeof diseases classified elsewhere
Conditions
Interventions
Intervention1: Gurunanda Fluoride free toothpaste with Neem and hydroxyapatite: Toothpaste to be brushed orally 2 times a day for 6 weeks
Control Intervention1: Placebo: Toothpaste to be brushed orall
Sponsors
GURUNANDA
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male or female subject 2.Subjects with atleast 20 permanent teeth excluding third molar. 3.Subjects having signs of gingivitis characterised by more than 30 percentage of bleeding sites with probing depth less than 3millimeter. 4.Subjects having 30 percentage teeth with gingival index scores of equal to or more than 1. 5.Subjects having plaque index scores of equal to or more than 1 in 10 percentage of the sites. 6.Subjects having extrinsic tooth stains. 7.Subjects having teeth shades of A2 or darker. 8.Subjects having atleast 2 teeth sensitive to evaporative air stimulus ( Schiff s score of more than or equal to 2). 9.Subjects should not use mouthwash 1 week prior to screening and during the whole course of the study 10.Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 11.Subjects should not have history of periodontal therapy one month prior to screening. 12.Patient should be able to give written informed consent prior to participating in the study
Exclusion criteria
Exclusion criteria: 1.Subjects with oral diseases such as chronic inflammatory periodontitis, gross oral pathology, frank dental caries, mucosal lesions. 2.Steroidal anti-inflammatory drugs, NSAIDs one month prior to screening. 3.Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, diabetes, gastritis psychiatric diseases, blood disorders, gastrointestinal diseases). 4.Subjects with orthodontic appliances. 5.Subjects with relatively severe stained teeth with tetracycline use. 6.Subjects with known sensitivity or oral mucosal tissue reaction to any components of the investigational product. 7.Pregnancy and breastfeeding women. 8.Participation in concomitant interventional clinical study during the previous 30 days. 9.Concurrent use of whitening products or treatments. 10.Recent dental procedures (e.g., scaling, polishing, or whitening) within the last 4 weeks 11.Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco. 12.Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period. 13.Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine). 14.Concurrent use of medications that may introduce bias into study assessments, including antibiotics, analgesics, and local anaesthetics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction of Plaque Index.Timepoint: Screening, week 3,6. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Reduction of Modified gingival Index. 2.Reduction of cariogenic oral microflora (S.mutans). 3.Change in teeth sensitivity by using Schiff sensitivity score 4.Change in stain score 5.Change in VITA shade scale 6.Compliance and tolerability. 7.Overall treatment satisfaction questionnaire.Timepoint: Screening, week 3,6. | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt. Ltd.
Outcome results
None listed