Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-03-02 @ 7:00 PM
Study NCT ID:
NCT04125706
Status:
UNKNOWN
Last Update Posted:
2019-10-16
First Post:
2019-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Locally Delivered Antibiotics for the Treatment of Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two parallel groups will receive two different locally delivered antibiotics'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-13', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plaque index', 'timeFrame': 'Baseline to six weeks', 'description': 'To measure the state of oral hygiene as:\n\n0 = No plaque in the gingival area\n\n1. = A film of plaque adhering to the free gingival margin and adjacent of the tooth\n2. = Moderate accumulation of soft deposits within the gingival pocket\n3. = Abundance of soft matter within the gingival pocket\n\nThe Plaque Index is the four gingival areas of the tooth (buccal, lingual/palatal, mesial, distal) given a score from 0-3 and scores were added and divided by four. The plaque index for the individual was obtained by adding the indices for the teeth and divide by the number of teeth examined.'}, {'measure': 'gingival index', 'timeFrame': 'Baseline to six weeks', 'description': 'To assess the gingival condition and record qualitative chances in the gingiva as:\n\n0 = Normal gingiva\n\n1. = Mild inflammation - slight change in color and slight edema but no bleeding on probing.\n2. = Moderate inflammation - redness, edema and glazing, bleeding on probing\n3. = Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.\n\nThe bleeding will be assessed by gently probing along the wall of the soft tissue of the gingival sulcus. To get the gingival index for the tooth, the four areas of the tooth (buccal, lingual/palatal, mesial, distal) are scored by the sum and divided by four. The gingival index for the individual will be obtained by adding the indices of the teeth and divided by the number of teeth examined.'}, {'measure': 'probing depth', 'timeFrame': 'Baseline to six weeks', 'description': 'The distance from the gingival margin to base of the sulcus. Will be measured at six sites per tooth (mesio-buccal, buccal, disto-buccal, disto-lingual, lingual and mesio-lingual) at all teeth with UNC-15 probe.'}, {'measure': 'IL6', 'timeFrame': 'Baseline to six weeks', 'description': 'In healthy subjects it ranges from 0.5-5 pg/ml In eosinophilic subjects it ranges from 3-18pg/ml in plasma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The sample consists of patients with moderate to severe periodontitis who will be subjected to machanical therapy in combination to local antibiotics. The participants will be divided into two groups, mechanical therapy with metronidazole hyclate, and mechanical therapy with minocycline hydrochloride. Both antibiotics will be delivered locally as gels. Outcome measures include probing pocket depth and several gingival indices. IL6 will be also measured for all participants.', 'detailedDescription': 'Forty-four patients in the age group of 25-50 years (males and females) who are suffering from periodontitis with almost similar probing depth bilaterally (≥ 6 mm) at the selected sites and exhibiting bleeding on probing.\n\nA written informed consent will be taken from the patients prior to the study.\n\nEach patient will be recalled 4 weeks after completion of both sides supra-gingival scaling, which formed the baseline visit. Plaque scores will be brought to zero, and the probing pocket depth and gingival index, will be recorded on the proforma specially prepared for the purpose.\n\nThe selected treatment sites will be then divided into two groups, and sub-gingival SRP will be performed prior to the delivery of the drugs at the test sites.\n\n* Group I: Consist of periodontal pockets on the left side of maxillary or mandibular arch and received sub-gingival Minocycline 2% gel.\n* Group II: Consist of periodontal pockets on the left side of maxillary or mandibular arch and received Metronidazole 0.75% gel.\n\nThe right side will be left as a control in both groups Patients will be recalled after 6 weeks from the baseline visit to record the plaque index, gingival index, bleeding index and probing depth (UNC probe 12 mm).\n\nStatistical Analysis:\n\nThe unit of measurement in this study is the site, rather than the subject. Student-t test was To compare between Group 1 (Minocycline 2 %) and Group 2 (Metronidazole 0.75 %), Data will check for normality, if the data normally distributed Independent t-test will use to test if there any significant differences between groups, otherwise if not normally Mann -Whitney U-test (Non-parametric) will use to detects the difference.\n\nTo achieve 80% power of statistical test to detect the differences between Metronidazole and Minocycline With 5 % level of significant, 19.6 reduction in probing depth (previous study-vi) and standard deviation of 0.23, using the following formula.\n\nn=(2σ\\^2 〖(Z\\_(β+Z\\_(1-α/2) ))〗\\^2)/d\\^2 22 per group (minimum sample size) where: σ =0.23 Zβ =0.84 Z(1-α/2) =1.96, d= 19.6%\n\nFor objective 2, the statistical test in case of normal data distribution will be paired t test or will use Willcoxon Sign Ranked test if it not normally distributed.\n\nTo achieve 80% power of statistical test to detect the differences between Metronidazole and Minocycline. With 5% level of significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from chronic periodontitis with almost similar probing depth bilaterally (≥\n* 6 mm) at the selected sites and exhibiting bleeding on probing Patients with no caries and restorations on the selected teeth\n* Patients showing effective individual oral hygiene.\n\nExclusion Criteria:\n\nPatients presenting with history of intake of local and/or systemic antibiotic therapy for the last 3 months\n\n* Patients with known systemic and debilitating diseases (Muscular Dystrophy)\n* Patients presenting with known adverse reactions to any component of the test agent\n* Patients on anticoagulant therapy\n* Pregnant and lactating females\n* Smokers\n* Patients in a regular use of mouth wash'}, 'identificationModule': {'nctId': 'NCT04125706', 'briefTitle': 'Locally Delivered Antibiotics for the Treatment of Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Elm University'}, 'officialTitle': 'Locally Delivered Antibiotics for the Treatment of Periodontitis Topical Doxycycline Versus Minocycline Gels as an Adjunct to Mechanical Treatment', 'orgStudyIdInfo': {'id': 'FRP/2019/53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mincycline hydrochloride 2% oral gel', 'description': 'Minocycline will be delivered locally in the periodontal pocket.', 'interventionNames': ['Drug: Minocycline Topical']}, {'type': 'EXPERIMENTAL', 'label': 'Metronidazole hylcate 0.75 % oral gel', 'description': 'Metronidazole gel will be delivered locally in the periodontal pocket.', 'interventionNames': ['Drug: Metronidazole Topical Gel']}], 'interventions': [{'name': 'Minocycline Topical', 'type': 'DRUG', 'otherNames': ['Dentomycin oral gel will be delivered locally in the periodontal pocket'], 'description': 'Minocycline will be delivered locally in the periodontal pocket', 'armGroupLabels': ['Mincycline hydrochloride 2% oral gel']}, {'name': 'Metronidazole Topical Gel', 'type': 'DRUG', 'otherNames': ['Roza 0.75% will be delivered locally in the periodontal pocket'], 'description': 'Metronidazole will be delivered locally in the periodontal pocket', 'armGroupLabels': ['Metronidazole hylcate 0.75 % oral gel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sasha M Suliman, MSc', 'role': 'CONTACT', 'email': 'sashasuliman@riyadh.edu.sa', 'phone': '966533215808'}, {'name': 'Omer AlKadhi', 'role': 'CONTACT', 'email': 'Omar.AlKadhi@riyadh.edu.sa'}], 'overallOfficials': [{'name': 'Sasha M Suliman, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ar Riyad, Saudi Arabia, 11681'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riyadh Elm University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Sasha Suliman', 'investigatorAffiliation': 'Riyadh Elm University'}}}}