Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT06535035
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Analgesic and Anti-Inflammatory Impact of Photobiomodulation in Patients With Dental Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'During the initial evaluation, data collection, informed consent, a complete clinical and oral evaluation, as well as a radiological study with cone beam computed tomography (CBCT) were carried out. Subsequently, surgical intervention was performed with the placement of dental implants. In the experimental group, low-level laser therapy (LLLT) was applied, while a placebo procedure (SHAM) was used in the control group. Pain and inflammation were evaluated using visual analog scales (VAS) from day 0 to 7 days postoperatively. Additionally, MDA levels were measured and the OHIP-14 questionnaire was used to assess oral health-related quality of life'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain levels assessed with the visual analogue scale (VAS)', 'timeFrame': '24h-48h,7 days', 'description': 'A score of 0 indicated no pain while 10 indicated the worst pain possible'}, {'measure': 'inflammation evels assessed with the visual analogue scale', 'timeFrame': '24h-48h,7 days', 'description': 'A score of 0 indicated no inflammation while 10 indicated the worst inflammation possible'}], 'secondaryOutcomes': [{'measure': 'Modified Corah Dental Anxiety Scale (MDAS)', 'timeFrame': 'at day 0 and 7 days', 'description': '(0 relaxed, 1 slightly anxious, 2 quite anxious, 3 very anxious or 4 extremely anxious). The total sum was obtained and 4 ranges of fear and anxiety were established (\\<9 mild or no anxiety, 9-12 moderate anxiety, 13-14 high anxiety, \\>14 phobic anxiety, \\>14 very anxious anxiety, \\>14 very anxious anxiety, \\>14 very anxious anxiety, \\>14 very anxious anxiety, \\>14 very anxious anxiety).'}, {'measure': 'OHIP-14sp', 'timeFrame': 'at 0 and at 7 days', 'description': "consists of 14 questions related to different dimensions of the patient's quality of life (functional limitation, pain, psychological problems, etc.) higher score worse quality of life"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laser; pain, dental implant , quality of life , MDA'], 'conditions': ['Dental Pain and Sensation Disorder']}, 'referencesModule': {'references': [{'pmid': '35490059', 'type': 'BACKGROUND', 'citation': 'Qu C, Luo F, Hong G, Wan Q. Effects of photobiomodulation therapy on implant stability and postoperative recovery: a systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2022 Jun;60(5):e712-e721. doi: 10.1016/j.bjoms.2022.01.014. Epub 2022 Feb 5.'}, {'pmid': '28549319', 'type': 'BACKGROUND', 'citation': 'Heidari M, Paknejad M, Jamali R, Nokhbatolfoghahaei H, Fekrazad R, Moslemi N. Effect of laser photobiomodulation on wound healing and postoperative pain following free gingival graft: A split-mouth triple-blind randomized controlled clinical trial. J Photochem Photobiol B. 2017 Jul;172:109-114. doi: 10.1016/j.jphotobiol.2017.05.022. Epub 2017 May 18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the analgesic and anti-inflammatory effects of photobiomodulation in participants undergoing dental implant placement.\n\nA randomized clinical trial was conducted with 62 participants requiring dental implant placement, divided into two groups of 31 each. Immediately after implant placement, one group received diode laser photobiomodulation, while the SHAM group received sham treatment. Pain and inflammation were assessed at 24 h, 48 h, and 7 days. In addition, Modified Dental Anxiety (MDA) levels were measured and the Oral Health Impact Profile-14 (OHIP-14) questionnaire was used to assess oral health-related quality of life.', 'detailedDescription': 'Low-Level Laser Therapy (LLLT) has revolutionized medicine, promoting the healing and regeneration of tissues in an innovative way. This study focuses on evaluating the powerful analgesic and anti-inflammatory effects of LLLT in patients undergoing dental implant placement.\n\nMethodology A randomized clinical trial was conducted with 62 patients, divided into two groups of 31 each. One group received photobiomodulation with a combined 630 and 808 nm diode laser, while the SHAM group received a simulated treatment.\n\nInclusion criteria: Participants who needed dental implant rehabilitation and signed the informed consent. Participants with a poor general health status, decompensated chronic diseases (diabetes) , pregnant women, and those with bleeding disorders were excluded.\n\nProcedure:\n\nInformed consent, data collection, complete clinical and oral evaluation, and radiological study with CBCT.\n\nSurgical intervention:\n\nPlacement of dental implants. In the experimental group, low-level laser therapy (LLLT) was applied immediately after the placement of the implants in a single session with an EPIC X Biolase diode laser (BIOLASE, Inc., USA), voltage 100-240 V, 1.5 A, power 0.5 W, 10-20 J, for 10-30 seconds. It was applied to three points in the area: buccal side, palatal/lingual side, and occlusal side to stimulate the tissue.\n\nPain and inflammation were evaluated using visual analog scales (VAS) from day 0 to 7 days postoperatively. Additionally, MDA levels were measured and the OHIP-14 questionnaire was used to assess oral health-related quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who needed dental implant rehabilitation and signed the informed consent\n\nExclusion Criteria:\n\n* Participants with a poor general health status, decompensated chronic diseases, pregnant women, and those with bleeding disorders were excluded.'}, 'identificationModule': {'nctId': 'NCT06535035', 'acronym': 'AAPDI', 'briefTitle': 'Evaluation of the Analgesic and Anti-Inflammatory Impact of Photobiomodulation in Patients With Dental Implants', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Murcia'}, 'officialTitle': 'Evaluation of the Analgesic and Anti-Inflammatory Impact of Photobiomodulation in Patients With Dental Implants', 'orgStudyIdInfo': {'id': '2934/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group1 laser therapy', 'description': 'Data collection, informed consent, a complete clinical and oral evaluation, as well as a radiological study with cone beam computed tomography (CBCT). A surgical intervention was performed with the placement of dental implants. In the experimental group, low-level laser therapy (LLLT) was applied immediately after the placement of the implants in a single session with an EPIC X Biolase diode laser (BIOLASE, Inc., USA), voltage 100-240 V, 1.5 A, power 0.5 W, 10-20 J, for 10-30 seconds. It was applied to three points in the area: buccal side, palatal/lingual side, and occlusal side to stimulate the tissue.Pain and inflammation were evaluated using visual analog scales (VAS) from day 0 to 7 days postoperatively. Additionally, MDA levels were measured and the OHIP-14 questionnaire was used to assess oral health-related quality of life', 'interventionNames': ['Device: laser therapy After implant surgery, laser therapy (LLLT) was applied']}, {'type': 'SHAM_COMPARATOR', 'label': 'group Sham', 'description': 'data collection, informed consent, a complete clinical and oral evaluation, as well as a radiological study with cone beam computed tomography (CBCT). Surgical intervention was performed with the placement of dental implants. In the group sham comparate p, low-level laser therapy (LLLT) was applied inactive . Pain and inflammation were evaluated using visual analog scales (VAS) from day 0 to 7 days postoperatively. Additionally, MDA levels were measured and the OHIP-14 questionnaire was used to assess oral health-related quality of life', 'interventionNames': ['Device: SHAM']}], 'interventions': [{'name': 'laser therapy After implant surgery, laser therapy (LLLT) was applied', 'type': 'DEVICE', 'otherNames': ['Experimental'], 'description': 'After implant surgery, laser therapy (LLLT) was applied a single session with an EPIC X Biolase diode laser (BIOLASE, Inc., USA)', 'armGroupLabels': ['Group1 laser therapy']}, {'name': 'SHAM', 'type': 'DEVICE', 'otherNames': ['After implant surgery, laser therapy (LLLT) was applied without activating it'], 'description': 'After implant surgery, After implant surgery, laser therapy (LLLT) was applied in the same manner but without activating it', 'armGroupLabels': ['group Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30008', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Pia Lopez Jornet', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Oral Medicine', 'investigatorFullName': 'Pia Lopez Jornet', 'investigatorAffiliation': 'Universidad de Murcia'}}}}