Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 3:53 PM
Study NCT ID:
NCT07056257
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2025-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunct Use of Diode Laser Therapy and Omega 3 Gel in Local Drug Delivery Approach on The Treatment of Localized Aggressive Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-29', 'studyFirstSubmitDate': '2025-06-29', 'studyFirstSubmitQcDate': '2025-06-29', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pocket depth', 'timeFrame': '6 months post-procedure', 'description': 'Probing pocket depth (PD) was recorded according to Ramfijord 1967.'}], 'secondaryOutcomes': [{'measure': 'Plaque score', 'timeFrame': '6 months post-procedure', 'description': 'Plaque score was recorded according to Silness and loe 1964.'}, {'measure': 'Bleeding on probing', 'timeFrame': '6 months post-procedure', 'description': 'Bleeding on probing (BOP) according to Ainamo and Bay 1975.'}, {'measure': 'Clinical attachment level loss', 'timeFrame': '6 months post-procedure', 'description': 'Clinical attachment level loss (CAL) according to according to Ramfijord 1967.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diode Laser Therapy', 'Omega 3', 'Localized Aggressive Periodontitis']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate and compare the effect of combination therapy between diode laser and omega3 gel in the local drug delivery approach as an adjunct to scaling and root planning on the management of localized aggressive periodontitis clinically and immunologically.', 'detailedDescription': 'Periodontitis is a disease of the periodontium occurring in an otherwise healthy adolescent, which is characterized by a rapid loss of alveolar bone about more than one tooth of the permanent dentition.\n\nThe laser approach is an efficient and atraumatic technique to enhance its use for periodontal treatment. Within the limits of scientific data, treatment with diode laser and SRP showed a higher effect than SRP or laser alone.\n\nOmega3 Polyunsaturated fatty acids (PUFA) have well recognized anti-inflammatory properties. They decrease inflammation through multiple pathways.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with localized aggressive periodontitis.\n* Patients must be medically free.\n* Optimal compliance as evidenced by no missed treatment appointments and a positive attitude to maintain oral hygiene.\n* Patients who are willing to participate in this study can enroll and complete it.\n\nExclusion Criteria:\n\n* Patients with generalized aggressive periodontitis. Patients are over 35 years old.\n* Pregnancy.\n* Patients had scaling and root planning or antibiotic therapy in the last 6 months.\n* Patients with hypersensitivity to fish oil.'}, 'identificationModule': {'nctId': 'NCT07056257', 'briefTitle': 'Adjunct Use of Diode Laser Therapy and Omega 3 Gel in Local Drug Delivery Approach on The Treatment of Localized Aggressive Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Effect of Adjunct Use of Diode Laser Therapy and Omega 3 Gel in Local Drug Delivery Approach on The Treatment of Localized Aggressive Periodontitis', 'orgStudyIdInfo': {'id': 'R-OMPDR-4-22-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'Thirteen sites \\[scaling-root planning (SRP)\\] were used as a control group.', 'interventionNames': ['Procedure: Scaling-root planning (SRP)']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'description': 'Thirteen sites \\[scaling-root planning (SRP)+ laser therapy with application of methyl cellulose gel at repeated times weekly for one month\\].', 'interventionNames': ['Procedure: Scaling-root planning (SRP)+ laser therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group III', 'description': 'Thirteen sites \\[scaling-root planning (SRP) + omega 3 gel repeated time weekly for one month\\].', 'interventionNames': ['Procedure: Scaling-root planning (SRP)+ omega 3 gel']}, {'type': 'EXPERIMENTAL', 'label': 'Group IV', 'description': 'Thirteen sites \\[combination therapy between scaling-root planning (SRP) + laser + omega 3 gel in repeated time weekly for one month\\].', 'interventionNames': ['Procedure: Scaling-root planning (SRP)+ laser therapy+ omega 3 gel']}], 'interventions': [{'name': 'Scaling-root planning (SRP)', 'type': 'PROCEDURE', 'description': 'Thirteen sites \\[scaling-root planning (SRP)\\] were used as a control group.', 'armGroupLabels': ['Group I']}, {'name': 'Scaling-root planning (SRP)+ laser therapy', 'type': 'PROCEDURE', 'description': 'Thirteen sites \\[scaling-root planning (SRP)+ laser therapy with application of methyl cellulose gel at repeated times weekly for one month\\].', 'armGroupLabels': ['Group II']}, {'name': 'Scaling-root planning (SRP)+ omega 3 gel', 'type': 'PROCEDURE', 'description': 'Thirteen sites \\[scaling-root planning (SRP) + omega 3 gel repeated time weekly for one month\\].', 'armGroupLabels': ['Group III']}, {'name': 'Scaling-root planning (SRP)+ laser therapy+ omega 3 gel', 'type': 'PROCEDURE', 'description': 'Thirteen sites \\[combination therapy between scaling-root planning (SRP) + laser + omega 3 gel in repeated time weekly for one month\\].', 'armGroupLabels': ['Group IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dentist at ministry of health', 'investigatorFullName': 'Dalia Mohammed Elsayed Ghannam', 'investigatorAffiliation': 'Tanta University'}}}}