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The Effects of Obesity on Glutathione Levels in Patients With Chronic Periodontitis Before and After Periodontal Therapy
Phase 1 Study of Periodontal Disease and Obese Individuals That Investigate of Local and Systemic Antioxidant Levels of Before and After Periodontal Treatment
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The purpose of this study was to investigate the effects of obesity on glutathione levels in the plasma, GCF and saliva of patients with chronic periodontitis and to evaluate changes after nonsurgical periodontal therapy.
Diagnosed as obese (n=30) and normal-weight (n=30) individuals were categorized; chronic periodontitis (CP) and periodontally healthy controls (PH). Gingival crevicular fluid (GCF), plasma, saliva samples and clinical measurements were obtained at baseline and a month after nonsurgical periodontal therapy.
Unstimulated salivary samples were collected using standard techniques. About 2 mL whole saliva was collected in disposable tubes and centrifuged immediately to remove cell debris (10,000 g x 10 minutes). The supernatants (50µL each) were stored at -40C until analyzed. GCF samples were collected from a mesio-buccal and disto-palatal site on each tooth. In the CP group, the samples were obtained from patients at areas with ≥5 mm CAL, ≥6 mm PD and ≥30% bone loss. In gingivitis group, GCF samples were obtained from teeth with BOP and without CAL. In the healthy group, GCF samples were collected from teeth exhibiting PD<3 mm without CAL and BOP. The area was isolated with cotton rolls, saliva contamination elimination was ensured, and it was slightly air dried. GCF was sampled with paper strips. Paper strips were placed into the crevice until mild resistance was felt (intracrevicular method) and left in the position for 30 seconds. Strips contaminated with blood or saliva were discarded. Each sampled strip was placed into a 400µl eppendorf centrifuge tube and stored at -40C until analyzed.
Five milliliters of venous blood was taken from antecubital vein by using a standard venipuncture method. Obtained blood sample was collected in vacutainer tubes and anti-coagulated with EDTA. The blood samples were then stored at -40C until required for use in ELISAs.
Power analysis indicated that 12 individuals for each group would be sufficient to achieve 80% power to detect a difference of 0.05 between the alternative and the null hypotheses.
The Shapiro Wilk test was used to investigate whether or not the data were normally distributed. Continuous variables with unequal variances were compared by means of Welch and Tamhane's T2 post-hoc test for BMI, PD, CAL and the levels of glutathione. The comparison of the age, GI, PI and BOP was analyzed using the Kruskal-Wallis non-parametric test followed by post hoc group comparisons with the Bonferroni-adjusted Mann-Whitney U test. Paired Student's t-test or Wilcoxon rank-sum test was used to compare the measurements at two points (baseline and after SRP). The Spearman's rank correlation test was also used to detect the relationship between biochemical and clinical findings.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- never-smokers
- no history of systemic disease
- no patients had been under periodontal therapy and medicine for at least 6 months before the study
- no pregnancy or lactation
- no alcohol or antioxidant vitamin consumption.
Exclusion Criteria:
-
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: obese-chronic periodontitis patients
GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy
|
Scaling and root planning under local anaesthesia, in a total of four clinical visits Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.
Andere namen:
|
|
Placebo-vergelijker: obese-periodontally healthy controls
GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions
|
Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush
Andere namen:
|
|
Actieve vergelijker: normal weight-CP patients
GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy
|
Scaling and root planning under local anaesthesia, in a total of four clinical visits Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.
Andere namen:
|
|
Placebo-vergelijker: normal weight-PH controls
GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions
|
Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Biochemical parameters (GSH and GSSG levels, GSH/GSSG ratio )
Tijdsspanne: Baseline and 1 month after treatment
|
The changes in levels of reduced and oxidized glutathione (GSH and GSSG) 1 month after periodontal treatment determined by ELISA.
The changes in levels of GSH were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontitis and obesity.
|
Baseline and 1 month after treatment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Zakdiepte peilen
Tijdsspanne: Baseline en 1 maand na de behandeling
|
De veranderingen in de diepte van de sondepocket na parodontale behandeling. De diepte van de sondepocket werd gemeten om de ernst van de ziekte en het klinische resultaat te bepalen.
|
Baseline en 1 maand na de behandeling
|
|
Zakdiepte en klinisch hechtingsniveau peilen
Tijdsspanne: Baseline en 1 maand na de behandeling
|
De veranderingen in klinisch hechtingsniveau na parodontale behandeling.
De sonderingsdiepte en de afstand van de gingivale rand tot de cement-glazuurovergang worden gebruikt om het klinische hechtingsniveau te meten.
Het klinische hechtingsniveau werd gemeten om de ernst van de ziekte en het resultaat van de kliniek te bepalen.
|
Baseline en 1 maand na de behandeling
|
|
Plaque-index
Tijdsspanne: Baseline en 1 maand na de behandeling
|
De veranderingen in plaque-index na parodontale behandeling.
Plaque-index werd geregistreerd voor het bepalen en classificeren van de mondhygiënestatus.
|
Baseline en 1 maand na de behandeling
|
|
Bloeden bij sonderen
Tijdsspanne: Baseline en 1 maand na de behandeling
|
De veranderingen in bloeding bij sonderen na parodontale behandeling.
Bloeden bij sonderen werd geregistreerd voor het classificeren en evalueren van (apisch) tandvleesontsteking.
|
Baseline en 1 maand na de behandeling
|
|
Gingival index
Tijdsspanne: Baseline and 1 month after treatment
|
he changes in gingival index after periodontal treatment.
Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation.
|
Baseline and 1 month after treatment
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2013-62550515-02
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