Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2026-03-12 @ 11:58 AM
Study NCT ID:
NCT07086027
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2025-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dental and Periodontal Health in Obese Adolescents: Clinical, Biochemical, and Microbiological Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva, serum, GCF, and subgingival plaque samples were collected. DNA was extracted from plaque samples for microbial analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary IL-1α Levels', 'timeFrame': 'At baseline (single time point, during sample collection visit)', 'description': 'This outcome measures the concentration of interleukin-1 alpha (IL-1α) in unstimulated saliva and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL'}, {'measure': 'Salivary IL-1β Levels', 'timeFrame': 'At baseline', 'description': 'This outcome measures the concentration of interleukin-1 beta (IL-1β) in unstimulated saliva and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL'}, {'measure': 'Salivary Leptin Levels', 'timeFrame': 'At baseline', 'description': 'This outcome measures the concentration of leptin in unstimulated saliva and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL'}, {'measure': 'Serum IL-1α Levels', 'timeFrame': 'At baseline', 'description': 'This outcome measures the concentration of interleukin-1 alpha (IL-1α) in serum samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL'}, {'measure': 'Serum IL-1β Levels', 'timeFrame': 'At baseline', 'description': 'This outcome measures the concentration of interleukin-1 beta (IL-1β) in serum samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL'}, {'measure': 'Serum Leptin Levels', 'timeFrame': 'At baseline', 'description': 'This outcome measures the concentration of leptin in serum samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL'}, {'measure': 'Gingival Crevicular Fluid (GCF) IL-1α Levels', 'timeFrame': 'At baseline', 'description': 'This outcome measures the concentration of interleukin-1 alpha (IL-1α) in GCF samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL'}, {'measure': 'GCF IL-1β Levels', 'timeFrame': 'At baseline', 'description': 'This outcome measures the concentration of interleukin-1 beta (IL-1β) in GCF samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL'}, {'measure': 'GCF Leptin Levels', 'timeFrame': 'At baseline', 'description': 'This outcome measures the concentration of leptin in GCF samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'at baseline', 'description': 'Unit of Measure: kg/m²\n\nDescription:\n\nBMI is calculated by dividing weight in kilograms by height in meters squared (kg/m²). Measurements will be used to classify participants as obese (BMI ≥ 95th percentile) or non-obese (BMI \\< 75th percentile) according to age- and sex-specific CDC growth charts. Higher BMI values indicate greater obesity severity.'}], 'secondaryOutcomes': [{'measure': 'Presence of Porphyromonas gingivalis in Subgingival Plaque', 'timeFrame': 'At baseline (single time point)', 'description': 'Detection of P. gingivalis in subgingival plaque samples using real-time PCR. Results will be compared between obese and non-obese adolescents. Unit of Measure: Presence/Absence (or Log genome equivalents if quantitative PCR used)'}, {'measure': 'Presence of Treponema denticola in Subgingival Plaque', 'timeFrame': 'At baseline (during clinical examination)', 'description': 'Detection of reponema denticola in subgingival plaque samples using real-time PCR. Results will be compared between obese and non-obese adolescents. Unit of Measure: Presence/Absence (or Log genome equivalents if quantitative PCR used)'}, {'measure': 'Presence of Tannerella forsythia in Subgingival Plaque', 'timeFrame': 'At baseline (during clinical examination)', 'description': 'Detection of Tannerella forsythia in subgingival plaque samples using real-time PCR. Results will be compared between obese and non-obese adolescents. Unit of Measure: Presence/Absence (or Log genome equivalents if quantitative PCR used)'}, {'measure': 'Presence of Actinobacillus actinomycetemcomitans in Subgingival Plaque', 'timeFrame': 'At baseline', 'description': 'Unit of Measure: Presence/absence (qualitative PCR)\n\nDescription:\n\nDetection of A. actinomycetemcomitans in subgingival plaque samples using real-time PCR. Results will be compared between obese and non-obese adolescents.'}, {'measure': 'Presence of Prevotella intermedia in Subgingival Plaque', 'timeFrame': 'At baseline', 'description': 'Unit of Measure: Presence/absence (qualitative PCR)\n\nDescription:\n\nPCR-based detection of P. intermedia in subgingival plaque. Prevalence will be compared between obese and non-obese adolescents.'}, {'measure': 'Presence of Candida albicans in Subgingival Plaque', 'timeFrame': 'At baseline', 'description': 'Unit of Measure: Presence/absence (qualitative PCR)\n\nDescription:\n\nIdentification of Candida albicans in subgingival plaque using real-time PCR and comparison of presence between obese and non-obese groups.'}, {'measure': 'Total Bacterial DNA in Subgingival Plaque', 'timeFrame': 'At baseline', 'description': 'Unit of Measure: Log genome equivalents/sample (quantitative PCR)\n\nDescription:\n\nTotal bacterial DNA load in subgingival plaque will be quantified using real-time PCR and compared between obese and non-obese adolescents.'}, {'measure': 'Plaque Index (PI) Score', 'timeFrame': 'At baseline (during clinical examination)', 'description': 'Unit of Measure: Index score (0-3 scale)\n\nDescription:\n\nPlaque accumulation will be assessed using the Silness and Löe Plaque Index. Scores range from 0 (no plaque) to 3 (abundant plaque). Higher scores indicate worse oral hygiene.'}, {'measure': 'Gingival Index (GI) Score', 'timeFrame': 'At baseline', 'description': 'Unit of Measure: Index score (0-3 scale)\n\nDescription:\n\nGingival inflammation will be evaluated using the Löe and Silness Gingival Index. Scores range from 0 (healthy) to 3 (severe inflammation). Higher scores indicate worse gingival health.'}, {'measure': 'Probing Depth (PD)', 'timeFrame': 'At baseline', 'description': 'Unit of Measure: Millimeters (mm)\n\nDescription:\n\nProbing depth will be measured at six sites per tooth using a Williams probe. Higher values indicate deeper periodontal pockets and worse periodontal condition.'}, {'measure': 'Bleeding on Probing (BOP)', 'timeFrame': 'at baseline', 'description': 'Unit of Measure: Percentage of sites with bleeding (%)\n\nDescription:\n\nThe proportion of periodontal sites that bleed upon gentle probing will be recorded. Higher percentages indicate greater gingival inflammation.'}, {'measure': 'Dental Caries Experience (dft Index)', 'timeFrame': 'At baseline', 'description': 'Unit of Measure: Number of affected teeth (dft score: 0 to 20)\n\nDescription:\n\nThe dft index (decayed and filled primary teeth) will be recorded to assess caries experience in the primary dentition. Scores range from 0 (no caries experience) to 20 (maximum caries experience in all primary teeth). Higher scores indicate worse dental health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Obesity', 'Periodontal Disease', 'Inflammation Biomarkers', 'Dental Plaque', 'Dental Caries']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate whether obesity affects oral and gum health in children and adolescents. A total of 75 children aged 8 to 13 years participated, including both obese and non-obese individuals. All participants received a dental examination, and samples of saliva, blood, and gum fluid were collected to measure specific inflammation-related substances (such as IL-1α, IL-1β, and leptin). The presence of specific bacteria in the mouth was also analyzed.', 'detailedDescription': 'This cross-sectional observational study aimed to investigate the relationship between pediatric obesity and periodontal health by integrating clinical, biochemical, and microbiological assessments. A total of 75 adolescents (36 obese and 39 non-obese), aged 8-13 years, were enrolled. Clinical oral evaluations included dft, DMFT, plaque index (PI), gingival index (GI), and probing depth (PD). Blood, saliva, and gingival crevicular fluid (GCF) samples were collected for ELISA-based measurement of pro-inflammatory biomarkers (IL-1α, IL-1β, and leptin). Subgingival plaque samples were analyzed using real-time PCR to quantify six key periodontal pathogens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 75 adolescents aged 8 to 13 years were included in the study. Participants were divided into two groups: obese (BMI \\> 95th percentile) and normal-weight (BMI 5th-85th percentile). Both groups were evaluated for periodontal status, inflammatory biomarkers, and subgingival microbiota.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren aged between 8 and 13 years\n\nParental consent obtained\n\nNo systemic diseases other than obesity\n\nNo current medication use\n\nExclusion Criteria:\n\nUse of antibiotics or anti-inflammatory drugs in the past 3 months\n\nHistory of systemic disease (other than obesity for the obese group)\n\nUndergoing orthodontic treatment\n\nMissing permanent first molars\n\nUncooperative behavior during examination'}, 'identificationModule': {'nctId': 'NCT07086027', 'acronym': 'PERIOBESITY', 'briefTitle': 'Dental and Periodontal Health in Obese Adolescents: Clinical, Biochemical, and Microbiological Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Clinical, Biochemical, and Microbiological Evaluation of Dental and Periodontal Health in Obese Adolescents: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': '2017-107'}, 'secondaryIdInfos': [{'id': 'Ethics Committee', 'type': 'OTHER', 'domain': 'Marmara University Faculty of Dentistry'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese Group', 'description': 'Adolescents aged 8-13 years with a body mass index (BMI) above the 95th percentile for age and sex, classified as obese. Participants underwent dental examination and provided saliva, serum, gingival crevicular fluid (GCF), and subgingival plaque samples for biomarker and microbiological analysis.'}, {'label': 'Control Group (Normal Weight)', 'description': 'Adolescents aged 8-13 years with a BMI between the 5th and 85th percentiles for age and sex, considered to have normal weight. The same clinical and sample collection procedures were applied as in the obese group.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Çağla Kondoz Torun, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University Faculty of Dentistry Department of Pediatric Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data (IPD) due to ethical and privacy considerations. The study was not designed with data sharing provisions, and participant consent for future data sharing was not obtained.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}