{ "evidence_kind": "Observed patient-linked pilot-study endpoint patterns, not complete pulp regeneration", "patient_registry": { "enrolled": 5, "one_affected_tooth_per_patient": true, "screened_or_approached": null, "Table4_24wk_EPT_status_records": 5, "Table4_24wk_apical_MRI_values": 5, "Table4_24wk_XR_symbols": 5, "unambiguous_binary_XR_radiolucency_states": 4, "Table4_CBCT_flags_with_unspecified_visit": 5, "same_unit_numeric_CBCT_volume_pairs": 1, "reported_formal_dropout_flow": null, "complete36wk_cohort_inferred": false }, "EPT_source_status_counts": { "onset_EPT_table4": { "denominator_enrolled_patients": 5, "observed_pattern_patient_ids": [ "1", "3", "4", "5" ], "observed_not_pattern_patient_ids": [ "2" ], "unknown_patient_ids": [], "count_bounds": [ 4, 4 ], "proportion_bounds": [ 0.8, 0.8 ], "meaning": "Exact finite-cohort identification bounds from reported categorical observations; no confidence interval, causal benefit or biological regeneration criterion" }, "EPT_12wk_table4": { "denominator_enrolled_patients": 5, "observed_pattern_patient_ids": [ "1", "3", "4", "5" ], "observed_not_pattern_patient_ids": [ "2" ], "unknown_patient_ids": [], "count_bounds": [ 4, 4 ], "proportion_bounds": [ 0.8, 0.8 ], "meaning": "Exact finite-cohort identification bounds from reported categorical observations; no confidence interval, causal benefit or biological regeneration criterion" }, "EPT_24wk_table4": { "denominator_enrolled_patients": 5, "observed_pattern_patient_ids": [ "1", "3", "4", "5" ], "observed_not_pattern_patient_ids": [ "2" ], "unknown_patient_ids": [], "count_bounds": [ 4, 4 ], "proportion_bounds": [ 0.8, 0.8 ], "meaning": "Exact finite-cohort identification bounds from reported categorical observations; no confidence interval, causal benefit or biological regeneration criterion" } }, "EPT_reading_audit": { "nested_device_readings": 36, "independent_patients": 5, "right_censored_readings": [ { "patient_id": "4", "source_endpoint": "onset_EPT_table4", "source_token": "80+" }, { "patient_id": "5", "source_endpoint": "onset_EPT_table4", "source_token": "80+" } ], "changed_control_tooth_patient_ids": [ "1", "3", "4" ], "normalized_longitudinal_sensory_recovery_percent": null, "interpretation": "Source categorical positivity only; device units are not linear nerve function. No averaging80+ as80 or averaging across changing control teeth." }, "MRI_24wk_apical_signal": { "patient_values": [ { "patient_id": "1", "relative_signal": 0.8 }, { "patient_id": "2", "relative_signal": 0.9 }, { "patient_id": "3", "relative_signal": 0.9 }, { "patient_id": "4", "relative_signal": 0.7 }, { "patient_id": "5", "relative_signal": 0.9 } ], "source_ratio_definition": "Ratio of root-canal tissue signal to surrounding dentin, compared with normal pulp/dentin in the opposite site; apical Table4 values only. No healthy threshold adopted.", "mean": 0.84, "median": 0.9, "minimum": 0.7, "maximum": 0.9, "source_defined_healthy_threshold": null, "direct_blood_flow": null, "native_pulp_identity_confirmed": null, "interpretation": "Continuous relative image signal, not perfusion, normal-tissue equivalence or a histological identity test" }, "linked_measured_patterns": { "EPT_positive_at_both12_and24_weeks": { "denominator_enrolled_patients": 5, "observed_pattern_patient_ids": [ "1", "3", "4", "5" ], "observed_not_pattern_patient_ids": [ "2" ], "unknown_patient_ids": [], "count_bounds": [ 4, 4 ], "proportion_bounds": [ 0.8, 0.8 ], "meaning": "Exact finite-cohort identification bounds from reported categorical observations; no confidence interval, causal benefit or biological regeneration criterion" }, "24wk_EPT_positive_and_MRI_value_available": { "denominator_enrolled_patients": 5, "observed_pattern_patient_ids": [ "1", "3", "4", "5" ], "observed_not_pattern_patient_ids": [ "2" ], "unknown_patient_ids": [], "count_bounds": [ 4, 4 ], "proportion_bounds": [ 0.8, 0.8 ], "meaning": "Exact finite-cohort identification bounds from reported categorical observations; no confidence interval, causal benefit or biological regeneration criterion" }, "24wk_MRI_value_available_and_unambiguous_XR_radiolucency_absence": { "denominator_enrolled_patients": 5, "observed_pattern_patient_ids": [ "1", "3", "5" ], "observed_not_pattern_patient_ids": [ "4" ], "unknown_patient_ids": [ "2" ], "count_bounds": [ 3, 4 ], "proportion_bounds": [ 0.6, 0.8 ], "meaning": "Exact finite-cohort identification bounds from reported categorical observations; no confidence interval, causal benefit or biological regeneration criterion" }, "24wk_EPT_positive_MRI_value_available_and_unambiguous_XR_radiolucency_absence": { "denominator_enrolled_patients": 5, "observed_pattern_patient_ids": [ "1", "3", "5" ], "observed_not_pattern_patient_ids": [ "2", "4" ], "unknown_patient_ids": [], "count_bounds": [ 3, 3 ], "proportion_bounds": [ 0.6, 0.6 ], "meaning": "Exact finite-cohort identification bounds from reported categorical observations; no confidence interval, causal benefit or biological regeneration criterion" }, "24wk_EPT_positive_with_XR_radiolucency_present": { "denominator_enrolled_patients": 5, "observed_pattern_patient_ids": [ "4" ], "observed_not_pattern_patient_ids": [ "1", "2", "3", "5" ], "unknown_patient_ids": [], "count_bounds": [ 1, 1 ], "proportion_bounds": [ 0.2, 0.2 ], "meaning": "Exact finite-cohort identification bounds from reported categorical observations; no confidence interval, causal benefit or biological regeneration criterion" } }, "MRI_availability_in_patterns": "All5 have a numeric Table4 ratio. Availability is not an MRI-positive or physiological-success classification.", "discordant_patient_records": [ { "patient_id": "2", "EPT_24wk_positive": false, "apical_MRI_ratio": 0.9, "XR_radiolucency": "Unresolved minus/plus, shrinking prior lesion and widened PDL; not coded absent", "late_EPT": "After36weeks footnote only; exact time and complete later cohort unavailable" }, { "patient_id": "4", "EPT_24wk_positive": true, "apical_MRI_ratio": 0.7, "XR_radiolucency": "Present at24weeks following PDL widening at12weeks; no causal attribution computed", "CBCT": "Positive lateral-mineralization flag at an unassigned Table4 visit; not a24-week joint criterion" } ], "CBCT_separate_source_flags": { "reported_lateral_mineralization_patient_ids": [ "1", "4", "5" ], "denominator_enrolled_patients": 5, "exact_visit_in_Table4": null, "native_dentin_or_mechanical_strength_confirmed": null, "volume_audits": [ { "patient_id": "1", "before_value": 0.0143, "before_unit_literal": "cm3", "after_value": 0.0125, "after_unit_literal": "cm3", "results_narrative_times_weeks": [ 16, 28 ], "timing_qualification": "Results narrative16/28weeks; no individual acquisition dates given", "endpoint": "CBCT threshold-defined low-density pulp-space volume, not direct tissue mass, perfusion or histological dentin volume", "eligible_for_24wk_joint_pattern": false, "status": "same_unit_printed_pair", "decrease_value": 0.0017999999999999995, "decrease_fraction": 0.12587412587412583 }, { "patient_id": "4", "before_value": 0.011, "before_unit_literal": "cm3", "after_value": 0.0081, "after_unit_literal": "m3", "results_narrative_times_weeks": [ 16, 28 ], "timing_qualification": "Figure3b labels16 and28/32weeks; patient4 Discussion instead mentions12/24weeks", "endpoint": "CBCT threshold-defined low-density pulp-space volume, not direct tissue mass, perfusion or histological dentin volume", "eligible_for_24wk_joint_pattern": false, "status": "source_unit_conflict", "decrease_value": null, "decrease_fraction": null, "interpretation": "No unit repair or conditional change computed; source unit/time conflicts remain unresolved" } ], "missing_initial_CBCT_patient5": true, "cohort_mean_volume_change": null }, "safety_and_limits": { "source_reports_no_attributed_systemic_or_clinical_events_through24wk": true, "source_lab_clinical_abnormality_symbols": { "1": { "Blood test": "\u2013", "Urine test": "\u2013", "Cardiogram": "\u2013", "Local clinical examination": "\u2013" }, "2": { "Blood test": "\u2013", "Urine test": "\u2013", "Cardiogram": "\u2013", "Local clinical examination": "\u2013" }, "3": { "Blood test": "\u2013", "Urine test": "\u2013", "Cardiogram": "\u2013", "Local clinical examination": "\u2013" }, "4": { "Blood test": "\u2013", "Urine test": "\u2013", "Cardiogram": "\u2013", "Local clinical examination": "\u2013" }, "5": { "Blood test": "\u2013", "Urine test": "\u2013", "Cardiogram": "\u2013", "Local clinical examination": "\u2013" } }, "new_patient4_radiographic_abnormality_preserved": true, "cell_karyotype_patterns_not_all_declared_normal": true, "long_term_safety_proven": false, "controlled_treatment_effect": null, "full_regeneration_success_count": null, "directly_measured_perfusion_or_human_pulp_histology_n": 0 } }