Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04495335
Status:
UNKNOWN
Last Update Posted:
2020-07-31
First Post:
2020-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Photobiomodulation and Implant Stability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Implants were randomly divided into two groups and implants placed in the test group were treated with Gallium-aluminum-arsenate (GaA1As) diode laser with photobiomodulation therapy immediately after surgery and for 15 days. In the control group, implants were not irradiated.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2020-07-26', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary and secondary implant stability', 'timeFrame': 'The stability was measured at immediately postoperatively.', 'description': 'Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.'}, {'measure': 'primary and secondary implant stability', 'timeFrame': 'The stability was measured at 30 days postoperatively.', 'description': 'Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.'}, {'measure': 'primary and secondary implant stability', 'timeFrame': 'The stability was measured at 60 days postoperatively.', 'description': 'Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.'}, {'measure': 'primary and secondary implant stability', 'timeFrame': 'The stability was measured at 90 days postoperatively.', 'description': 'Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the number of peri-implant total microorganisms by PCR', 'timeFrame': 'Microbiological samples will obtained at the first 24-hour after implant surgery', 'description': 'The sample of the dental implant to be sampled is gently isolated with sterile cotton rolls. Then standardized sterile endodontic paper-points with tip size 40 were inserted into crevice very gently avoiding gingival bleeding. The paper-points were immediately put into sterilized Eppendorf tubes.'}, {'measure': 'Evaluation of the number of peri-implant total microorganisms by PCR', 'timeFrame': 'Microbiological samples will obtained at the 90 days after implant surgery', 'description': 'The sample of the dental implant to be sampled is gently isolated with sterile cotton rolls. Then standardized sterile endodontic paper-points with tip size 40 were inserted into crevice very gently avoiding gingival bleeding. The paper-points were immediately put into sterilized Eppendorf tubes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low-level laser therapy implants'], 'conditions': ['Photobiomodulation Therapy']}, 'referencesModule': {'references': [{'pmid': '16672018', 'type': 'BACKGROUND', 'citation': 'Lioubavina-Hack N, Lang NP, Karring T. Significance of primary stability for osseointegration of dental implants. Clin Oral Implants Res. 2006 Jun;17(3):244-50. doi: 10.1111/j.1600-0501.2005.01201.x.'}, {'pmid': '17523169', 'type': 'BACKGROUND', 'citation': 'Kim YD, Kim SS, Hwang DS, Kim SG, Kwon YH, Shin SH, Kim UK, Kim JR, Chung IK. Effect of low-level laser treatment after installation of dental titanium implant-immunohistochemical study of RANKL, RANK, OPG: an experimental study in rats. Lasers Surg Med. 2007 Jun;39(5):441-50. doi: 10.1002/lsm.20508.'}, {'pmid': '25653816', 'type': 'BACKGROUND', 'citation': 'Amid R, Kadkhodazadeh M, Ahsaie MG, Hakakzadeh A. Effect of low level laser therapy on proliferation and differentiation of the cells contributing in bone regeneration. J Lasers Med Sci. 2014 Fall;5(4):163-70.'}, {'pmid': '33851765', 'type': 'DERIVED', 'citation': 'Bozkaya S, Uraz A, Guler B, Kahraman SA, Turhan Bal B. The stability of implants and microbiological effects following photobiomodulation therapy with one-stage placement: A randomized, controlled, single-blinded, and split-mouth clinical study. Clin Implant Dent Relat Res. 2021 Jun;23(3):329-340. doi: 10.1111/cid.12999. Epub 2021 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'Objective: The aim of the present study was to address the following questions: does photobiomodulation therapy (PBMT) improve implant stability and affect microbiota around dental implants in the early stage of osseointegration.\n\nMaterial and Methods: Implants will randomly be divided into two groups and implants will be placed in the test group treating with Gallium-aluminum-arsenate (GaA1As) diode laser with photobiomodulation therapy immediately after surgery and for 15 days. In the control group, implants are not irradiated. The primary stability of the implants will measure by the Resonance frequency analysis (RFA) after insertion and the secondary stability values will record at 30th, 60th, and 90th days after surgery as implant stability quotient (ISQ). Plaque samples will collect for microbiological analyzes at the first 24 hours after implant surgery and six days after 90 days at six sterile endodontic paper points.', 'detailedDescription': "The same surgical procedure will be operated in the test and control groups by the same surgeon. Full-thickness flaps were raised and dental implant osteotomy preparation will be completed according to the manufacturers' instructions. Laser treatment will be completed using Gallium-Aluminum-Arsenide diode laser. The photobiomodulation application will v-be completed by laser energy immediately and three times a week for just 15 days after surgery. The control group will consist of laser application without energy delivery to the tissue. Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer will be applied for direct measurement of implant stability and the value will be recorded. The microbiological plaque samples will be collected at specific times, according to the following schedule; at the first 24-hour and 90 days after implant surgery. All bacterial DNA specimen will be analyzed with qPCR technique to evaluate Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) , Tannerella forsythia (Tf ) and total amount of bacteria."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least one tooth loss in left and right posterior sides of upper and lower jaws\n* adequate alveolar bone volume as horizontal and vertical\n\nExclusion Criteria:\n\n* uncontrolled systemic diseases\n* parafunctional (bruxism and/or clenching)\n* smoking habits\n* any allergies or metabolic bone diseases,\n* pregnancy\n* surgical periodontal treatment in 6 months\n* using antibiotics in the last 6 months'}, 'identificationModule': {'nctId': 'NCT04495335', 'acronym': 'low-laser', 'briefTitle': 'Photobiomodulation and Implant Stability', 'organization': {'class': 'OTHER', 'fullName': 'T.C. Dumlupınar Üniversitesi'}, 'officialTitle': 'The Effect of Photobiomodulation Application on Implant Stabilization and Peri-implant Microbiology', 'orgStudyIdInfo': {'id': '2020-04/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group (TG)', 'description': 'The study included test group with Photobiomodulation treatment after dental implant surgery', 'interventionNames': ['Device: photobiomodulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (CG)', 'description': 'The control group consisted of laser application without energy delivery to the tissue.', 'interventionNames': ['Device: photobiomodulation']}], 'interventions': [{'name': 'photobiomodulation', 'type': 'DEVICE', 'otherNames': ['low-level laser therapy'], 'description': 'Laser treatment will complete using Gallium-Aluminum-Arsenide (GaA1As) diode laser and application will complete by laser energy immediately and three times a week for just 15 days after surgery.', 'armGroupLabels': ['Control Group (CG)', 'Test Group (TG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43100', 'city': 'Kütahya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Berceste Guler, DDs PhD', 'role': 'CONTACT', 'email': 'berceste.guler@ksbu.edu.tr', 'phone': '905059359207'}, {'name': 'Ahu Uraz, DDS PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Suleyman Bozkaya, DDS PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kütahya Health Sciences University Faculty of Dentistry', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}], 'centralContacts': [{'name': 'Berceste Guler, PhD', 'role': 'CONTACT', 'email': 'berceste.guler@ksbu.edu.tr', 'phone': '905059359207'}], 'overallOfficials': [{'name': 'Suleyman Bozkaya, DDS PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gazi University Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'T.C. Dumlupınar Üniversitesi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gazi University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS PhD, Assist Prof', 'investigatorFullName': 'Berceste Guler', 'investigatorAffiliation': 'T.C. Dumlupınar Üniversitesi'}}}}