Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-06 @ 6:08 AM
Study NCT ID:
NCT07254260
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy and Post-Endodontic Pain in Undergraduate-Performed Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011671', 'term': 'Pulpitis'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010778', 'term': 'Photochemotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Intensity (Visual Analog Scale - VAS)', 'timeFrame': 'Time Frame: 6, 24, 48, and 72 hours after treatment Unit of Measure: VAS score (0-10)', 'description': 'Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst pain imaginable." Higher scores indicate greater pain intensity.'}], 'secondaryOutcomes': [{'measure': 'Analgesic Consumption (Number of Tablets Taken)', 'timeFrame': 'Up to 72 hours after treatment', 'description': 'The number of analgesic tablets consumed by each participant during the postoperative period will be recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postendodontic pain'], 'conditions': ['Pulpitis']}, 'referencesModule': {'references': [{'pmid': '27330702', 'type': 'RESULT', 'citation': 'Chiniforush N, Pourhajibagher M, Shahabi S, Kosarieh E, Bahador A. Can Antimicrobial Photodynamic Therapy (aPDT) Enhance the Endodontic Treatment? J Lasers Med Sci. 2016 Spring;7(2):76-85. doi: 10.15171/jlms.2016.14. Epub 2016 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'To compare the intensity and trajectory of postoperative pain (0-72 hours) between (A) a conventional final irrigation protocol without activation and (B) a PDT-augmented final disinfection in mandibular molars and premolars.', 'detailedDescription': 'This retrospective controlled clinical cohort study investigated the effects of photodynamic therapy (PDT) on post-endodontic pain in mandibular molars and premolars treated by undergraduate students. Eligible patients were selected from the Istanbul Atlas University Faculty of Dentistry clinics. Inclusion criteria encompassed adult patients requiring endodontic treatment in posterior teeth, without systemic contraindications or signs of acute apical abscess.\n\nParticipants were assigned to one of two groups:\n\n(A) conventional final irrigation without activation (control), and (B) PDT-augmented final disinfection (experimental).\n\nAll treatments were performed by undergraduate dental students under faculty supervision. Root canals were shaped using a standardized rotary instrumentation protocol. In both groups, final irrigation included 2.5% sodium hypochlorite (NaOCl), followed by 17% EDTA for smear layer removal.\n\nIn the experimental group, after completion of the same irrigation regimen, a methylene blue photosensitizer was introduced into the canal and allowed to remain for 60 seconds. The dye was subsequently activated using an intra-canal diode laser fiber for 60 seconds per canal, following manufacturer instructions for photodynamic therapy. All canals were obturated at the second visit using the single-cone technique.\n\nPostoperative pain was measured using a visual analog scale (VAS) at 6, 24, 48, and 72 hours after treatment. Additional variables such as analgesic consumption, incidence of flare-ups, unscheduled visits, and the time required to achieve a pain-free state were also recorded. This study aimed to determine whether adjunctive PDT could reduce early post-endodontic pain in treatments performed by undergraduate practitioners.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18-60 years who received primary endodontic treatment of mandibular premolars or molars at the Istanbul Atlas University Faculty of Dentistry student clinic. All treatments were performed by undergraduate dental students under supervision. Eligible patients had no systemic diseases and presented with teeth requiring primary root canal therapy without intraoperative complications.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18-60 years Patients requiring primary endodontic treatment of posterior teeth (premolars or molars) Patients without systemic diseases Patients treated at the Istanbul Atlas University Faculty of Dentistry student clinic Teeth with no intraoperative complications (no perforation, no instrument separation, no ledge formation) Treatments completed with either photodynamic therapy (PDT) activation or no activation (control group)\n\nExclusion Criteria:\n\nTeeth with previous root canal treatment Teeth with open apices Presence of severe periodontal disease Incomplete clinical or radiographic records Patients with systemic conditions that may influence postoperative pain perception Any intraoperative complications during treatment (perforation, ledge, instrument separation, etc.) Presence of acute apical abscess'}, 'identificationModule': {'nctId': 'NCT07254260', 'acronym': 'PDT', 'briefTitle': 'Photodynamic Therapy and Post-Endodontic Pain in Undergraduate-Performed Treatments', 'organization': {'class': 'OTHER', 'fullName': 'Atlas University'}, 'officialTitle': 'Photodynamic Therapy (PDT) and Postendodontic Pain', 'orgStudyIdInfo': {'id': 'E-22686390-050.99-78516'}, 'secondaryIdInfos': [{'id': 'E-22686390-050.99-78516', 'type': 'OTHER', 'domain': 'Istanbul Atlas University Non-Interventional Scientific Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional Final Irrigation Without Activation (Control Group)', 'description': 'The final irrigation protocol consisted of sequential rinses with saline, 17% ethylenediaminetetraacetic acid (EDTA; Wizard, Turkey), and distilled water and 2.5% sodium hypochlorite (NaOCl; Wizard, Turkey), which was activated during this step, followed by a final flush with saline solution.', 'interventionNames': ['Device: Photodynamic Therapy']}, {'label': 'Brief Title: The Effect of Photodynamic Therapy on Post-Endodontic Pain in Treatments P', 'description': 'Following completion of standard chemomechanical preparation and photodynamic therapy (PDT) was performed using the Easyinsmile Photodynamic PDT 630 System (Easyinsmile Co., Ltd., Changsha, Hunan, China). A low-range photosensitizer solution (Easyinsmile Photosensitizer, methylene blue-based formulation, λ\\_max = 630 nm) was delivered into each prepared root canal using the dedicated delivery syringe tip provided with the photosensitizer, ensuring precise, controlled placement of the agent while minimizing the risk of apical extrusion. The Easyinsmile endo-type light guard tip (diameter: 200 µm; emission wavelength: 630 ± 10 nm; optical power density: approximately 100 mW/cm²) was inserted into the canal. Photoactivation was then performed for 30 seconds per canal (10-second periods x 3).', 'interventionNames': ['Device: Photodynamic Therapy']}], 'interventions': [{'name': 'Photodynamic Therapy', 'type': 'DEVICE', 'description': 'the Easyinsmile endo-type light guard tip (diameter: 200 µm; emission wavelength: 630 ± 10 nm; optical power density: approximately 100 mW/cm²) was inserted into the canal. Photoactivation was then performed for 30 seconds per canal (10 second periods x 3).', 'armGroupLabels': ['Brief Title: The Effect of Photodynamic Therapy on Post-Endodontic Pain in Treatments P', 'Conventional Final Irrigation Without Activation (Control Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34400', 'city': 'Istanbul', 'state': 'Kağıthane', 'country': 'Turkey (Türkiye)', 'facility': 'Ayfer ATAV ATEŞ', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlas University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Ayfer Atav', 'investigatorAffiliation': 'Atlas University'}}}}