{"type":"trials","record":{"id":33966,"source_id":"clinicaltrials-gov","external_id":"NCT03693027","title":"Evaluation of a Daily Oral Care Lozenge on Oral Health and Quality of Life in Older Adults","brief_summary":"The assessment of a daily oral care lozenge (PTx800) will be compared to a placebo control in a cohort of older adults who visit adult senior centers and who also have mild to moderate gingivitis. The comparison of the pre-to post change in gum health and pathogen burdens will be measured over a 6 week period. In addition, the feasibility and acceptability of using the lozenges will be assessed in this older adult population.","overall_status":"Unknown","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Primal Therapies Inc.","enrollment":60,"countries":["United States"],"start_date":"2018-06-01","completion_date":"2018-12-31","last_update_date":"2018-10-09","source_url":"https://clinicaltrials.gov/study/NCT03693027","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Unknown. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:11.953004+00:00","last_seen_at":"2026-09-25T06:25:08.953+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years to 85 Years","comparator":"Placebo","organization":"Primal Therapies Inc.","interventions":["PTx800 lozenges","Placebo control"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change from Baseline of Bacterial Burden — Measured at baseline and at 6 weeks","Change from Baseline of Oral Health — Measured at baseline and at 6 weeks","Change from Baseline in oral health behaviors and habits — Measured at baseline and at 6 weeks"],"design_description":"RANDOMIZED · PARALLEL · OTHER · QUADRUPLE","source_has_results":false},"controlled_terms":["Oral Health","PTx800 lozenges","Placebo control"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: oral health.","quality_checked_at":"2026-09-25T06:25:14.10514+00:00","duplicate_cluster_key":"id:nct03693027","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2018-06-01 to 2018-12-31","comparator":"Placebo","confidence":"structured-source","population":"ALL · 60 Years to 85 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:09.039Z","intervention":["PTx800 lozenges","Placebo control"],"participants":60,"study_design":"RANDOMIZED · PARALLEL · OTHER · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change from Baseline of Bacterial Burden — Measured at baseline and at 6 weeks","Change from Baseline of Oral Health — Measured at baseline and at 6 weeks","Change from Baseline in oral health behaviors and habits — Measured at baseline and at 6 weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"oral-health-aging","is_published":true,"match_reasons":["Title contains controlled term: oral health.","Source terminology contains: oral health.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Oral health and ageing","slug":"oral-health-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/33966","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}