Chronic Periodontitis
Conditions
Brief summary
This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month while clinical parameters \[plaque index (PI), gingival index (GI), sulcus bleeding index (SBI), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (GR), stain index (SI)\] were evaluated at base line, 1 month, and 3 months. CFU was also evaluating at above said time periods.
Detailed description
This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month.The primary outcome of this study was CAL, while PPD was the secondary outcome measure. A single clinician (AA) who was blinded to the groups assigned to the individuals, recorded all the parameters i.e. PI, GI, SBI, PPD, CAL, GR, SI at base line (prior to the treatment), 1 and 3 months after therapy. PPD, CAL and GR were recorded at the six sites per tooth in every tooth, except third molar, with a manual UNC-15 periodontal probe (Hu-Friedy, Leinmen, Germany) to the nearest millimeter. For recording of parameters at different time periods patients were instructed to refrain from any oral hygiene procedure for 8 hours prior to the evaluation. Staining of the six maxillary anterior teeth was assessed using the Lobene index. CFUs of P. ginigvalis, T. forsythia, and T. denticola were evaluated at baseline , 1 months, 3 months.
Interventions
Sponsors
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* systemically healthy individuals of \> 30 years of age with previously untreated generalized chronic periodontitis (defined by Armitage in 1999), * having minimum 15 teeth, * minimum of six teeth with at least one interproximal site with PPD between 5-7mm, * CAL between 5-10 mm, at least 30% of the sites with PPD and CAL ≥ 5 mm * presence of bleeding on probing (BOP).
Exclusion criteria
* was any systemic disease, * use of any medication in the previous 6 months, * subjects wearing partial removal prosthesis or orthodontic appliance, * allergy to ingredient used in the study, alcoholics, smokers or tobacoo users in any form, mentally retarded individual, pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment loss | 3 Months | Distance from cemento enamel junction to base of the pocket |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth | 3 Months | Distance from ginigval margin to base of the pocket |
| colony forming units | 3 months | numbers of colonies of bacteria using anaerobic culture |
Countries
India
Outcome results
None listed