{"type":"trials","record":{"id":42816,"source_id":"clinicaltrials-gov","external_id":"NCT02419144","title":"Good Oral Health - A Bi-level Intervention to Improve Older Adult Oral Health","brief_summary":"This study will test an intervention designed to change oral health norms and reduce disparities in oral health among vulnerable adults residing in publicly funded senior housing in Central Connecticut. The intervention model is based on Fishbein modified theory of reasoned action operationalized through Adapted Motivational Interviewing and Practice to Mastery. The intervention includes two components: 1) a face to face administration of the Adapted Motivational Interviewing and Practice to Mastery, a participatory counseling model, and 2) a targeted building level campaign consisting of three half-day oral health events with skills development through practice to mastery to parallel the individual intervention, all based on the study's conceptual model. The study uses a modified fractional factorial design to evaluate the face to face and campaign components separately and in different additive sequences. Six buildings will be paired in three dyads. The buildings in each dyad will be randomized to either having the Adapted Motivational Interviewing and Practice to Mastery intervention first followed by campaigns or to having the campaigns first followed by Adapted Motivational Interviewing and Practice to Mastery. Seventy-five residents will be recruited in each building for a total of 450 participants. There will be four assessments: 1. T0 will include a survey, oral hygiene skills assessment and clinical assessment of the Gingival Index and Plaque Score. The survey will provide data on the conceptual domains that are the target of the tailored intervention 2. T1 will follow the AMI-PM or CA+PM (depending on condition) and will include the survey, oral hygiene skills assessment and clinical assessment of the Gingival Index and Plaque Score. This assessment will occur 1-2 months after the initial intervention 3. T2 will follow the AMI-PM or CA+PM and will include the survey, oral hygiene skills assessment and clinical assessment of the Gingival Index and Plaque Score. This assessment will occur 6 months after the initial intervention 4. T3 will include oral hygiene skills assessment and clinical assessment of the Gingival Index and Plaque Score. This will occur 15-18 months after study entry. We will use general linear mixed models (GLMM) or general estimating equations (GEE), respectively, to fit a model with intervention and period effects using the MIXED procedure in SAS.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"UConn Health","enrollment":331,"countries":["United States"],"start_date":"2015-05-01","completion_date":"2020-07-31","last_update_date":"2021-03-11","source_url":"https://clinicaltrials.gov/study/NCT02419144","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:36.493571+00:00","last_seen_at":"2026-09-25T06:25:08.953+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"18 Years","comparator":"AMI followed by campaigns; Campaigns followed by AMI","organization":"UConn Health","interventions":["AMI and campaigns"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in Plaque scores from preintervention, at one month post intervention, 3 months post intervention and 6 months —…","Change in Gingival Index from preintervention, at one month post intervention, 3 months post intervention and 6 months…","Change in Oral Health Related Quality of Life Change from preintervention, at one month post intervention, 3 months pos…"],"design_description":"RANDOMIZED · FACTORIAL · PREVENTION · NONE","source_has_results":false},"controlled_terms":["Gingivitis","AMI and campaigns"],"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:nct02419144","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2015-05-01 to 2020-07-31","comparator":"AMI followed by campaigns; Campaigns followed by AMI","confidence":"structured-source","population":"ALL · 18 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":"2026-09-25T06:25:09.032Z","intervention":["AMI and campaigns"],"participants":331,"study_design":"RANDOMIZED · FACTORIAL · PREVENTION · NONE","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 in Plaque scores from preintervention, at one month post intervention, 3 months post intervention and 6 months —…","Change in Gingival Index from preintervention, at one month post intervention, 3 months post intervention and 6 months…","Change in Oral Health Related Quality of Life Change from preintervention, at one month post intervention, 3 months pos…"],"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.","Abstract contains controlled term: oral health.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","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/42816","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}