CTRI/2023/03/050348
Recruiting
Phase 2
A randomized, double-blind, placebo-controlled trial of individualized homoeopathic medicines in addition to standard care in chronic periodontitis in adults
D N De Homoeopathic Medical College and Hospital0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- D N De Homoeopathic Medical College and Hospital
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with chronic periodontitis, as diagnosed by the periodontitis screening and recording (PSR) (ICD10 code: K05\.30\), symptoms persisting for 3 months or more, as assessed by:
- •a) Gingival plaque (score up to 3\)
- •b) Altered gingival margins (rolled, flattened, recessions)
- •c) Bleeding on probing (BOP; score up to 3\)
- •d) Periodontal probing depth (PPD; up to 4\-5\.5mm)
- •e) Clinical attachment loss (CAL; moderate 3 to 4 mm)
- •2\. Patients having at least 22 teeth present
- •3\. Age 18 to 65 years
- •3\. Participants of either sex
- •4\. Literate: ability to read English, Hindi and/or Bengali (Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the questionnaires).
Exclusion Criteria
- •1\. Severe form of chronic periodontitis (more than 5 mm CAL) or aggressive periodontitis
- •2\. Patients who have undergone nonsurgical periodontal treatment (NSPT) within 6 months.
- •3\. Antibiotics and steroids therapy for periodontitis or gingivitis or any other similar conditions in the last month
- •4\. Patients having orthodontic appliances
- •5\. Cases having severe oral inflammation unrelated to periodontal conditions
- •6\. Cases requiring immediate tooth extraction
- •7\. Vulnerable population \- unconscious, non\-ambulatory, differently abled, terminally ill or critically ill patients, mentally incompetent people.
- •8\. Diagnosed cases of unstable mental or psychiatric illness, infectious disease (e.g., tuberculosis) or other uncontrolled or life\-threatening illness affecting quality of life or any organ failure
- •9\. Tobacco chewing and/or smocking, alcoholism, and/or any other form(s) of substance
- •10\. Self\-reported immune\-compromised state e.g., HIV
Outcomes
Primary Outcomes
Not specified
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