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Aggressive Periodontitis, GeneralizedNCT04020315

GCF HIF-1α, VEGF and TNF-α Levels in G-AgP Patients Before and After Periodontal Treatment.

A study testing Non-surgically performed scaling and root planing in people with Aggressive Periodontitis, Generalized and Periodontal Health, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hypoxia-inducible angiogenic pathway involving hypoxia inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor (VEGF) and tumour necrosis factor- alpha (TNF-α) may regulate the several biological processes related to inflammation. Read more about this study

Who is it for?
Ages 25 to 45 yearsHealthy volunteers can take part
What is being tested?
Non-surgically performed scaling and root planing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2017to 15 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • aged 25 to 45 years
  • non-smokers with no history of smoking
  • having at least 20 natural teeth.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Adnan Menderes University, Faculty of Dentistry, Department of Periodontology

    Aydin, 09100

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Non-surgical Periodontal Treatment on GCF HIF-1α, VEGF and TNF-α Levels in Generalized Aggressive Periodontitis Patients.

Hypoxia-inducible angiogenic pathway involving hypoxia inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor (VEGF) and tumour necrosis factor- alpha (TNF-α) may regulate the several biological processes related to inflammation. Generalized aggressive periodontitis (G-AgP) is a rare but highly destructive form of inflammatory periodontal disease. The present study aimed to assess the effect of non-surgical periodontal treatment on gingival crevicular fluid (GCF) HIF-1α, VEGF and TNF-α levels in G-AgP patients. 20 G-AgP and 20 periodontally healthy subjects were enrolled. At baseline, GCF samples were collected and whole mouth clinical periodontal parameters were recorded. G-AgP patients received non-surgical periodontal treatment. Clinical parameters and GCF cytokines were re-measured at 1 and 3 months after treatment. GCF HIF-1α, VEGF and TNF-α levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.

Read the 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.

Being tested
Non-surgically performed scaling and root planing
Keywords
aggressive periodontitis, gingival crevicular fluid, hypoxia, cytokines
Medical subject headings
Aggressive Periodontitis, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-surgically performed scaling and root planingProcedure or surgery

    Non-surgically performed scaling and root planing

Study groups in NCT04020315
Study groupRoleWhat they receive
Generalized aggressive periodontitisExperimentalNon-surgically performed scaling and root planing.
Receives: Procedure: Non-surgically performed scaling and root planing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gingival crevicular fluid protein content change

    pg/ml

    Measured: Change from baseline to 1 month and 3 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study start1 Dec 2017
  3. Primary completion30 Aug 2018
  4. Study completion15 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04020315
Sponsor's protocol ID
AggressiveHIF
Status last verified
Jul 2019
First submitted
12 Jul 2019
Last updated
17 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Non-surgically performed scaling and root planing in people with Aggressive Periodontitis, Generalized and Periodontal Health, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gingival crevicular fluid protein content change (time frame: Change from baseline to 1 month and 3 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.

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