Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-29 @ 7:14 PM
Study NCT ID:
NCT06270004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'smoker and non smoker patients with unstable periodontitis'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-02-19', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients.', 'timeFrame': 'baseline, one month and three months', 'description': 'salivary concentration of osteopontin between smoker and nonsmoker unstable periodontitis patients following NSPT at different time intervals.'}], 'secondaryOutcomes': [{'measure': 'Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients.', 'timeFrame': 'baseline, one month and three months', 'description': 'salivary concentration of osteonectin between smoker and nonsmoker unstable periodontitis patients following NSPT at different time intervals .'}, {'measure': 'Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients', 'timeFrame': 'baseline, one month and three months', 'description': 'salivary concentration of histatin1 between smoker and nonsmoker unstable periodontitis patients following NSPT at different time intervals.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteonectin', 'osteopontin', 'histatin1'], 'conditions': ['Non Surgical Periodontal Therapy']}, 'descriptionModule': {'briefSummary': '1. To assess the alteration in the level of salivary osteopontin (OPN), osteonectin(ON) and histatin-1 following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals(one month and three months) .\n2. To evaluate the response of clinical periodontal parameters ( plaque index ,bleeding on probing ,probing pocket depth ,clinical attachment loss)following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals (one month and three months)', 'detailedDescription': 'the study include nonsurgical periodontal therapy for smoker and non smoker patients with unstable periodontitis and evaluate the clinical periodontal parameters ( plaque index, bleeding on probing , probing pocket depth ,clinical attachment loss) and assess the alteration in the level of salivary osteopontin (OPN), osteonectin(ON) and histatin-1 following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals(one month and three months)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* participants will be systemically healthy without history of any systemic diseases.\n* hadn't underwent periodontal treatment during the previous 6 months and not taken medication during the previous 3 months.\n* present with at least 20 teeth, those who only diagnosed with 4-6 mm probing pocket depth, generalized ,unstable periodontitis who had bone loss \\> 30% , probing probing pocket depth at ≥4mm . Periodontitis cases were defined if clinical attachment loss was detected at ≥2 non- adjacent teeth or when buccal (facial) showed clinical attachment loss ≥3mm associated with probing pocket depth \\>3mm at ≥ 2 teeth .\n* The patients in the smokers group will be current smokers ( cigarette smokers) with smoking habit for over 3 years\n\nExclusion Criteria:\n\n* Subjects have any intraoral plaque retentive factors such as those wearing partial denture, crown and bridges, and orthodontic appliances ,furcation involved teeth, overhang filling, tooth anomaly.\n* receiving antibiotic therapy during the previous 3 months.\n* those with systemic diseases such as diabetes mellitus, cardiovascular or renal diseases, etc…., pregnant or lactating women, not willing to participate or continue to conduct the study."}, 'identificationModule': {'nctId': 'NCT06270004', 'briefTitle': 'Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients', 'orgStudyIdInfo': {'id': 'nonsurgical periodontal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nonsmoker periodontitis patients', 'interventionNames': ['Other: nonsurgical periodontal therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'smoker periodontitis patients', 'description': 'cigarette smoker more the three years ago', 'interventionNames': ['Other: nonsurgical periodontal therapy']}], 'interventions': [{'name': 'nonsurgical periodontal therapy', 'type': 'OTHER', 'description': 'sonic scaler for scaling and polishing. Graces curettes numbers(1-2,3-4,5-6,7-8,9-10,11-12,13-14)for root surfaces debridement(RSD), instructions and motivation for dental arch', 'armGroupLabels': ['nonsmoker periodontitis patients', 'smoker periodontitis patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aqeel Ali, baccalaureus', 'role': 'CONTACT', 'email': 'aqeel.ali2205@codental.uobaghdad.edu.iq', 'phone': '+96407705518935'}, {'name': 'Maha shukri, master', 'role': 'CONTACT', 'email': 'mahashukri@codental.uobaghdad.edu.iq', 'phone': '+96407716249206'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Iraq ,baghdad', 'investigatorFullName': 'Aqeel Ali', 'investigatorAffiliation': 'University of Baghdad'}}}}