- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04020315
GCF HIF-1α, VEGF and TNF-α Levels in G-AgP Patients Before and After Periodontal Treatment.
Effect of Non-surgical Periodontal Treatment on GCF HIF-1α, VEGF and TNF-α Levels in Generalized Aggressive Periodontitis Patients.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Population and Clinical Examination
A total of 40 individuals were recruited for the present study. Inclusion criteria included: 1) aged 25 to 45 years 2) non-smokers with no history of smoking 3) having at least 20 natural teeth. Exclusion criteria were as follows: 1) having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases 2) usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months 3) having any non-inflammatory destructive periodontal disease 4) nonsurgical/surgical periodontal therapy received in the past year 5) having a restorative and endodontic treatment requirement 6) having orthodontic appliances or a removable partial denture 7) pregnant/ lactating/ postmenopausal females.
The whole mouth clinical periodontal examination included measurement of probing depth (PPD), clinical attachment level (CAL), presence of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) at 6 sites per tooth, except the third molars. The presence and type of the alveolar bone loss were assessed on the digital panoramic radiograph in each participant, which was supplemented with periapical radiographs if necessary.
Periodontal status of each patient was evaluated by a single calibrated periodontists with a manual probe. The diagnosis of G-AgP or periodontally health was determined according to the International Classification of Periodontal Diseases in 1999. The patients in G-AgP group (n=20) had a minimum three teeth apart from the first molars and incisors showing CAL ≥5 mm and PPD ≥6 mm. Radiographic bone loss was ≥30 % of root length affecting ≥3 teeth other than first molars and incisors. This generalized pattern of severe destruction was inconsistent with the amount of microbial deposits. Patients had at least one other family member presenting with or having a history of severe periodontal problems. Periodontally healthy individuals (n=20) in the control group had no sites with PPD >3 mm and CAL >2 mm and also no radiographic evidence of alveolar bone loss. BOP was <15% in the whole mouth.
Treatment
The recruited G-AgP patients received conventional quadrant scaling and root planning (SRP) under local anaesthesia for 3 weeks. SRP was performed by the same periodontist (who was different the investigator recorded periodontal parameters) using ultrasonic inserts and manual periodontal curettes. Re-evaluations were performed at 1 and 3 months following the completion of the SRP in the lower right quadrant. No periodontal intervention was carried out in the periodontally healthy controls.
GCF sampling
GCF was sampled from two deepest pockets of single-rooted teeth at baseline in G-AgP group immediately before the treatment of upper right quadrant. Sampling was repeated at the same sites following the completion of the SRP in the lower right quadrant. GCF was sampled from the buccal aspects of two nonadjacent interproximal sites in single-rooted teeth with. Samples were collected from the sites without BOP in the periodontally healthy group. Standardized filter paper strips were used for GCF sampling. Sterile paper strips were gently inserted into the gingival sulcus or pocket until mild resistance was felt and left there for 30 s. The absorbed fluid volume was measured with a precalibrated electronic device. The paper strips were stored at -40◦C for further analysis.
Measurement of HIF-1α, VEGF and TNF-α Levels in GCF
Two paper strips were pooled, placed in 300 µL PBS-T (0.05%). HIF-1α, VEGF and TNF-α levels in GCF samples were measured by the enzyme-linked immunosorbent assay using commercial kits in line with the manufacturer's guidelines. GCF results were expressed as both total amounts at two sites per sampling time.
Statistical Analysis
All statistical analyses were carried out with the standard statistical software package. For the intra-group comparisons, if the data were not normally disturbed, Friedman test and the Dunn test with the Bonferroni correction were used to analyze the change between baseline and 1 month and 3 months after treatment. For inter-group comparisons, Mann-Whitney U test for normally and non-normally disturbed data. The Spearman's rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each others in diseased group before and after treatment. All tests were performed at significance level of P <0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aydın, Turkey, 09100
- Adnan Menderes University, Faculty of Dentistry, Department of Periodontology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged 25 to 45 years
- non-smokers with no history of smoking
- having at least 20 natural teeth.
Exclusion Criteria:
- having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases
- usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months
- having any non-inflammatory destructive periodontal disease
- nonsurgical/surgical periodontal therapy received in the past year
- having a restorative and endodontic treatment requirement
- having orthodontic appliances or a removable partial denture
- pregnant/ lactating/ postmenopausal females.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Generalized aggressive periodontitis
Non-surgically performed scaling and root planing.
|
Non-surgically performed scaling and root planing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gingival crevicular fluid protein content change
Time Frame: Change from baseline to 1 month and 3 months after treatment
|
pg/ml
|
Change from baseline to 1 month and 3 months after treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AggressiveHIF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontal Health
-
Beni-Suef UniversityRecruitingPeriodontal HealthEgypt
-
Kırıkkale UniversityCompletedInnate Immunity | Periodontal Health
-
Queen Mary University of LondonCompletedRetention | Compliance | Periodontal Health | OrthodonticUnited Kingdom
-
Alsayed Mohamed Alsayed AlsadanyUnknownPeriodontal HealthEgypt
-
Marmara UniversityCompletedPeriodontitis | Periodontal HealthTurkey
-
Marmara UniversityCompletedPeriodontitis | Periodontal HealthTurkey
-
Marmara UniversityCompletedPeriodontitis | Periodontal HealthTurkey
-
University of JordanRecruitingGingival Recession | Gingival Retraction | Periodontal HealthJordan
-
National Institute of Dental and Craniofacial Research...CompletedDental Plaque | Periodontal Disease | Oral Health | Periodontal Disease and CariesUnited States
-
Aydin Adnan Menderes UniversityCompletedPeriodontitis | Gingivitis | Periodontal HealthTurkey
Clinical Trials on Non-surgically performed scaling and root planing
-
Marmara UniversityCompletedPeriodontitis | Periodontal HealthTurkey
-
Marmara UniversityCompleted
-
University of NebraskaCompletedPeriodontal Diseases | Periodontitis, Apical, Chronic Nonsuppurative | Suppuration of Gingival CreviceUnited States
-
University of CataniaCompletedPeriodontal DiseasesItaly
-
Institut Straumann AGCompleted
-
Maharashtra University of Health SciencesCompletedChronic PeriodontitisIndia
-
Mohammed Bin Rashid University of Medicine and...RecruitingPeriodontal DiseasesUnited Arab Emirates
-
Milagros Rocha BarajasInstituto de Salud Carlos IIIRecruitingPeriodontal DiseasesSpain
-
Cairo UniversityCompletedType 2 Diabetes Mellitus | Chronic PeriodontitisEgypt
-
University of California, Los AngelesBiolase IncCompletedPeriodontitis Chronic Generalized Moderate | Periodontitis Chronic Generalized Severe