Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04477551
Status:
UNKNOWN
Last Update Posted:
2021-09-14
First Post:
2020-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054023', 'term': 'Lasers, Semiconductor'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-10-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-11', 'studyFirstSubmitDate': '2020-07-03', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Full mouth plaque score (FMPS).', 'timeFrame': 'Change from baseline FMPS at six months', 'description': 'The plaque score is calculated by expressing as a percentage the number of surfaces harbouring plaque related to the total number of tooth surfaces.'}, {'measure': 'Full mouth bleeding score (FMBS).', 'timeFrame': 'Change from baseline FMBS at six months', 'description': 'The bleeding score is calculated by expressing as a percentage the number of sites that bleed upon probing in relation to the total number of tooth sites.'}, {'measure': 'Probing pocket depth (PPD).', 'timeFrame': 'Change from baseline PPDs at six months', 'description': 'PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.'}, {'measure': 'Clinical attachment level (CAL).', 'timeFrame': 'Change from baseline CALs at six months', 'description': 'CAL is calculated from a fixed reference point (cementoenamel junction or CEJ), and it is computed by calculating the distance from the CEJ to the base of the pocket in millimeters.'}, {'measure': 'Number of sites PPDs ≥ 6 mm.', 'timeFrame': 'Change from baseline number of sites with PPDs ≥ 6 mm at six months', 'description': 'Number of sites with PPDs ≥ 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.'}, {'measure': 'Percentages of sites PPDs ≥ 6 mm.', 'timeFrame': 'Change from baseline percentages of sites with PPDs ≥ 6 mm at six months', 'description': 'Percentages of sites with PPDs ≥ 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.'}], 'secondaryOutcomes': [{'measure': 'Operating time', 'timeFrame': 'Outcome measures will be recorded at baseline', 'description': 'Time required to complete the procedure'}, {'measure': 'Postoperative pain', 'timeFrame': 'Change from baseline pain at seven days', 'description': 'Patient-related outcomes (pain) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome'}, {'measure': 'Postoperative swelling', 'timeFrame': 'Change from baseline swelling at seven days', 'description': 'Patient-related outcomes (swelling) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome'}, {'measure': 'Postoperative bleeding', 'timeFrame': 'Change from baseline bleeding at seven days', 'description': 'Patient-related outcomes (bleeding) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome'}, {'measure': 'Postoperative bruising', 'timeFrame': 'Change from baseline bruising at seven days', 'description': 'Patient-related outcomes (bruising) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome'}, {'measure': 'Postoperative root sensitivity', 'timeFrame': 'Change from baseline root sensitivity at seven days', 'description': 'Patient-related outcomes (root sensitivity) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome'}, {'measure': 'Quality of life measures', 'timeFrame': 'Change from baseline GOHAI score at six months days', 'description': 'Patient\'s quality of life will be evaluated using general oral health assessment index (GOHAI). The GOHAI has 12 negatively and positively worded items evaluating three dimensions of oral health related quality of life (physical function, pain or discomfort and psychosocial function).\n\nThe score ranged from 0 to 60. The scores are maintained for the three items "able to swallow comfortably", able to eat without discomfort", "pleased with look of teeth", and reversed for the remaining nine items, so that a higher score was associated with a more positive oral health.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': "Periodontal disease is serious and global chronic disease. The prevalence of periodontal diseases in United Arab Emirates is not clear but data from Dubai Health Authority showed that one in five patients has received periodontal treatment in recent years.\n\nSeveral studies reported the additional benefits provided by the use of diode laser in combination with ultrasonic debridement in the treatment of gum disease. The use of diode laser may debridement of deep pocketing areas while improving healing of gum tissues.\n\nThe aim of the study is to compare the effect of removing bacterial deposit (biofilm) from deep tooth pocket using combined diode laser and conventional pocket debridement versus conventional pocket debridement alone on tooth supporting tissue parameters in patients with advanced gum disease (periodontitis).\n\nMethodology: A total of 22 patients with advanced gum disease will be randomly allocated to two groups: a control group, which will receive conventional pocket debridement and a test group which will receive ultrasonic debridement with diode laser. Gum measurements will be recorded by a masked calibrated examiner at six points for each tooth and patients' postoperative experience and satisfaction will be assessed using special forms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 or over.\n* Diagnosed with unstable generalised periodontitis, stage III-IV and grade B or C.\n* Good compliance and commitment to attend follow-up review appointments.\n* Willing to provide informed consent.\n\nExclusion Criteria:\n\n* Received periodontal treatment in the last 12 months.\n* Received systemic antibiotic in the last 6 months.\n* Pregnancy or lactating participants'}, 'identificationModule': {'nctId': 'NCT04477551', 'briefTitle': 'The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Mohammed Bin Rashid University of Medicine and Health Sciences'}, 'officialTitle': 'The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MBRU/IRB/2020/006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diode laser (device) with scaling and root planing', 'description': 'Diode laser (device) with conventional scaling and root planing', 'interventionNames': ['Procedure: Diode laser (device) with scaling and root planing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional scaling and root planing', 'description': 'Conventional scaling and root planing', 'interventionNames': ['Procedure: Conventional scaling and root planing']}], 'interventions': [{'name': 'Diode laser (device) with scaling and root planing', 'type': 'PROCEDURE', 'description': 'Combined use of diode laser device and scaling instruments to remove plaque and calculus from the surface of the roots of teeth.', 'armGroupLabels': ['Diode laser (device) with scaling and root planing']}, {'name': 'Conventional scaling and root planing', 'type': 'PROCEDURE', 'description': 'Use of scaling instruments to remove plaque and calculus from the surface of the roots of teeth.', 'armGroupLabels': ['Conventional scaling and root planing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '505097', 'city': 'Dubai', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Momen A Atieh, BDS, MSc, DClinDent, PhD', 'role': 'CONTACT'}], 'facility': 'Dubai Dental Hospital', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}], 'centralContacts': [{'name': 'Momen A Atieh, BDS, MSc, DClinDent, PhD', 'role': 'CONTACT', 'email': 'momen.atieh@mbru.ac.ae', 'phone': '+97143838905'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohammed Bin Rashid University of Medicine and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair and Associate Professor (Periodontology)', 'investigatorFullName': 'Associate Professor Momen Atieh', 'investigatorAffiliation': 'Mohammed Bin Rashid University of Medicine and Health Sciences'}}}}