- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02220751
Diagnostic Biomarkers Related to Periodontal Disease Activity in Diabetic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This case-control longitudinal study was carried out at University of São Paulo between March 2009 and June 2012 as a joint collaboration of the Department of Oral Surgery and Periodontology and the Department of Internal Medicine, Division of Endocrinology and Metabolism. It was reviewed and approved by the Institutional Human Ethics Research Committee of the Ribeirão School of Dentistry - University of Sao Paulo (process n. 2009.1.88.58.7).
The clinical attachment loss above 1 mm was determined according to the tolerance method adapted to the computerized periodontal probe, considering the standard deviation of 0.3 mm for the electronic probe multiplied by 3. Teeth with prosthesis or furcation lesions were not considered. The periodontal sites that had this clinical attachment were called active sites.
Before beginning the initial clinical examination, a supragingival scaling with ultrasonic device was performed to facilitate the examination. The clinical parameters evaluated were: probing pocket depth, relative clinical attachment level and bleeding on probing were recorded at six sites per tooth with the aid of a computerized periodontal probe. To reduce the variations between baseline and 12-month evaluations, an acrylic stent was used to standardize the position of the computerized periodontal probe. Bleeding on probing was assessed according to presence or absence of bleeding up to 20 seconds after probing. The plaque index, presence or absence of biofilm, was recorded at four sites per tooth. It was also verified the furcation involvement with the aid of a manual periodontal probe.
All clinical parameters were recorded two weeks after supragingival scaling (baseline) and two months after non-surgical periodontal therapy by one-blinded calibrated examiner. A calibration exercise was performed to achieve acceptable intraexaminer reproducibility.
For the metabolic control assessment, the HbA1c levels were analyzed in patients from both groups at baseline and two months after non-surgical periodontal therapy, at the Endocrinology Clinic of the Ribeirão Preto School of Medicine, University of São Paulo. All diabetics were under the supervision of an endocrinologist advised to communicate any change in medicine intake or diet.
A program of plaque control with dental prophylaxis and oral hygiene instruction, and the scaling and root planning sessions were performed by the same operator using curettes and an ultrasonic device in PD and PD+DM groups. All scaling and root planning procedures were inspected for a second operator. Oral hygiene was reviewed after a week and after a month of periodontal disinfection, followed by dental prophylaxis.
In PD+DM group, the non-surgical periodontal therapy was associated with systemic doxycycline 100 mg/day, for two weeks after an initial dose of 200 mg, started on the day before periodontal therapy. Patients of the PD group had no access to information about antibiotics administration to patients of the PD+DM group.
Non-stimulated whole expectorated saliva was collected (~ 3 ml) from each subject into sterile tubes. Subjects were refrained from eating, drinking, and oral hygiene for 2 hours prior to saliva collection. Saliva samples were placed on ice immediately and aliquoted prior to freezing at -80º Celsius. Samples were thawed and analyzed within 6 months of collection.
A complete series of radiographs was taken in each patient at baseline, using the paralleling technique. Two months after periodontal therapy, radiographs were taken with the same technique in teeth with active periodontal sites. Thereafter, the radiographs were digitized in tagged image file format (TIFF) on a scanner. Digital subtraction radiographs were performed with the baseline and 2-month radiographs using specific software. Only teeth with interproximal sites with periodontal disease activity were included in this analysis. Changes between radiographs were depicted as a darkened area for loss of alveolar bone mass. These areas were measured (mm2) using specific measurements software. As in the clinical examination, it was performed intra-examiner calibration for the measurements of areas of radiographic density loss.
Gingival tissue samples were obtained from active sites of the each patient in both groups during regular periodontal surgery. The excised gingival collar was then carefully removed from the roots and the alveolar process. Gingival biopsy comprised epithelial and connective tissues. The samples are immediately submerged into liquid nitrogen to be then stored at -80º Celsius for RNA extraction and gene expression analysis.
Total RNA from biopsies was extracted using the Trizol reagent according to the directions supplied by the manufacturer. From 1 µg of total RNA, a strand of complementary DNA (cDNA) was synthesized through a reverse transcription reaction according to the directions supplied by the manufacturer. At the end of this reaction, cDNA was stored at -20º Celsius for later use. The Real Time Polymerase Chain Reaction (PCR) Array allowed simultaneous analysis of 84 genes involved in specific signaling pathways. The genes included in PCR array plates for human inflammatory cytokines and receptors.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Sao Paulo
-
Ribeirao Preto, Sao Paulo, Brazil, 14040-904
- Mario Taba Jr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adults aged between 35 to 65 years old;
- a minimum of 14 natural teeth, 10 of which should be posterior teeth;
- periodontitis case definition was the presence of five teeth with a probing pocket depth of ≥ 5 mm and clinical attachment loss of ≥ 3 mm;
- type 2 diabetes for at least 5 years and with glycated hemoglobin level > 7%.
Exclusion Criteria:
- smoking within the last 5 years;
- pregnancy or lactating;
- use of antibiotics or periodontal therapy in the previous six months;
- concomitant medical therapy, except for diabetic condition;
- other inflammatory conditions;
- major diabetic complications such as retinopathy, nephropathy, neuropathy and atherosclerosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: chronic periodontitis
Non-surgical periodontal therapy.
|
A program of plaque control with dental prophylaxis and oral hygiene instruction, and the scaling and root planning sessions were included in the non-surgical periodontal therapy.
The scaling and root planning was performed by the same operator using curettes and an ultrasonic device, and it was inspected for a second operator.
Oral hygiene was reviewed after a week and after a month of periodontal disinfection, followed by dental prophylaxis.
Other Names:
|
Active Comparator: Chronic periodontitis + type 2 diabetes
Non-surgical periodontal therapy + systemic doxycycline non-surgical periodontal therapy was associated with systemic doxycycline 100 mg/day, for two weeks after an initial dose of 200 mg, started on the day before first scaling and root planning session.
|
A program of plaque control with dental prophylaxis and oral hygiene instruction, and the scaling and root planning sessions were included in the non-surgical periodontal therapy. The scaling and root planning was performed by the same operator using curettes and an ultrasonic device, and it was inspected for a second operator. Oral hygiene was reviewed after a week and after a month of periodontal disinfection, followed by dental prophylaxis. Non-surgical periodontal therapy was associated with systemic doxycycline 100 mg/day, for two weeks after an initial dose of 200 mg, started on the day before the first scaling and root planning session. Patients of the PD group had no access to information about antibiotics administration to patients of the PD+DM group.
Other Names:
|
No Intervention: Control
Periodontal- and systemically healthy patients were included as control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical attachment level
Time Frame: baseline and two months
|
relative clinical attachment level (rCAL) was recorded at six sites per tooth with the aid of a computerized periodontal probe.
|
baseline and two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gene expression
Time Frame: Two months
|
Gingival tissue samples were obtained from periodontal sites (active or non-active) of the each patient in both groups during regular periodontal surgery.
The samples are immediately submerged into liquid nitrogen to be then stored at -80º Celsius for RNA extraction and cDNA synthesis.
The Real Time-PCR Array allowed simultaneous analysis of 84 genes involved in specific signaling pathways, including specific human inflammatory cytokines and receptors.
|
Two months
|
Salivary proteins levels
Time Frame: baseline and two months
|
Non-stimulated whole expectorated saliva was collected (~ 3 ml) from each subject into sterile tubes and stored at -80º Celsius.
The salivary inflammatory proteins levels were identified simultaneously using Multiplex Cytokine Profiling Assay, which allows the simultaneous detection of multiple analytes in saliva sample size.
|
baseline and two months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing pocket depth
Time Frame: baseline and two months
|
It was recorded at six sites per tooth with the aid of a computerized periodontal probe.
|
baseline and two months
|
Bleeding on probing
Time Frame: baseline and two months
|
It was recorded at six sites per tooth with the aid of a computerized periodontal probe, and it was assessed according to presence or absence of bleeding up to 20 seconds after probing.
|
baseline and two months
|
Plaque index
Time Frame: baseline and two months
|
It was recorded at four sites per tooth to assess presence or absence of dental biofilm.
|
baseline and two months
|
Glycated hemoglobin level
Time Frame: baseline and two months
|
Metabolic control assessment
|
baseline and two months
|
Density loss
Time Frame: baseline and two months
|
A complete series of radiographs was taken in each patient at baseline, using the paralleling technique.
Two months after periodontal therapy, radiographs were taken with the same technique in teeth with active periodontal sites.
The radiographs were digitized in tagged image file format (TIFF) on a scanner.
Digital subtraction radiographs were performed with the baseline and 2-month radiographs using specific software.
Changes between radiographs were depicted as a darkened area for loss of alveolar bone mass.
These areas were measured (mm2) using specific measurements software.
|
baseline and two months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Priscila P Costa, PhD, Department of Oral Surgery and Periodontology - Ribeirão Preto School of Dentistry, University of São Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Stomatognathic Diseases
- Mouth Diseases
- Diabetes Mellitus, Type 2
- Periodontitis
- Periodontal Diseases
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Doxycycline
Other Study ID Numbers
- 2008/11033-9 (Other Grant/Funding Number: FAPESP2008/11033-9)
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