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FM-SRP and Tooth Extraction Improve Type 2 Diabetes Mellitus in Periodontitis

17. august 2016 opdateret af: Dashor Bukleta, University Clinical Centre of Kosova

Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus

This intervention study is designed to evaluate the effects of non-surgical procedure in addition to surgical procedure on systemic inflammation and glycemic control in with type 2 diabetes mellitus patients with periodontitis in comparison with non-diabetic periodontic patients.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In a randomize, prospective study 200 patients from the endocrinology department of "Peja's Regional Hospital" and Dental Polyclinic at city of Peja, will be assessed and examined for eligibility. Personal interviews will be used to collect the baseline data from each participant using a pre structured questionnaire.

After clinical examination, 160 patients aged 30-70 years will be selected for the study. These will be further divided in four groups: type 2 diabetes mellitus group (with or without initial periodontal therapy) and non-diabetic group (with or without initial periodontal therapy).

All the patients will be with periodontal disease and at least one tooth extraction will perform. Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (FM-SRP) with ultrasonic device (UDS-J Ultrasonic Scaler, Guilin Woodpecker Medical Instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus.

Post operative rinsing will be followed with antiseptic solution Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) as a mouthwash thrice a day for 3 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kosovo
      • Peja, Kosovo, 10000
        • Rekruttering
        • Oral Surgery, Dental Polyclinic (HUCSK)
        • Kontakt:
        • Ledende efterforsker:
          • Dashnor Bukleta, Dr

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosed with type 2 Diabetes Mellitus; having a baseline HbA1c ≥ 6.5%, at least 10 teeth in the functional dentition (excluding third molars) and a clinical diagnosis of periodontal disease with at least one site with probing depth (PD) ≥ 5mm, and two teeth with attachment lost ≥ 6mm and no modification in the pharmacological treatment of diabetes during the study period.

Exclusion Criteria:

  • Pregnancy or lactation, major diabetic complications, uses of antibiotic therapy or non-steroidal anti-inflammatory drug therapy 4 months before the first visit.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Surgical periodontal treatment

Type 2 Diabetes Patients with periodontitis (without initial non-surgical periodontal therapy) at least one tooth extraction will be performed.

Non-Diabetes Patients with periodontitis (without initial non-surgical periodontal therapy) at least one tooth extraction will be performed.

Intervention:

Procedure: Surgery (Tooth Extraction)
Procedure: Surgical Periodontal Treatment
In the patient's with periodontal disease at least one tooth extraction will be performed.
Andre navne:
  • Tandekstraktion
Aktiv komparator: Surgical and non-surgical periodontal treatment

Type 2 Diabetes Patients with periodontitis (with initial non-surgical periodontal therapy) at least one tooth extraction will be performed.

Non-Diabetes Patients with periodontitis (with initial non-surgical periodontal therapy) at least one tooth extraction will be performed.

Interventions:

Procedure: Surgery (Tooth Extraction)

Procedure: Non-surgical periodontal therapy-full mouth scaling and root planing (FM-SRP) with ultrasonic device and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus, post operative rinsing thrice a day for 3 weeks.
Procedure: Surgical Periodontal Treatment
In the patient's with periodontal disease at least one tooth extraction will be performed.
Andre navne:
  • Tandekstraktion
Enhed: Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.
Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (FM-SRP) with ultrasonic device (UDS-J Ultrasonic Scaler, Guilin Woodpecker Medical Instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus.
Andre navne:
  • FM-SRP
Medicin: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)
Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) for the 3 weeks after tooth extraction and cleaning.
Andre navne:
  • Mouth wash

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biochemical parameter: HbA1c (mean value in %),
Tidsramme: Baseline and 3 months after
The changes in levels of glycated haemoglobin after periodontal treatment.
Baseline and 3 months after
Biochemical parameter: high sensitive C-Reactive Protein - hs-CRP (mean value in mg/L)
Tidsramme: Baseline and 3 months after
The changes in levels of c-reactive protein after periodontal treatment.
Baseline and 3 months after

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bleeding on probing (BOP) (expressed in %)
Tidsramme: Baseline and 3 months after
The changes in bleeding on probing after periodontal treatment.
Baseline and 3 months after
Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter)
Tidsramme: Baseline and 3 months after
The changes in clinical attachment level after periodontal treatment.
Baseline and 3 months after
Plaque index (PI) (expressed in %)
Tidsramme: Baseline and 3 months after
The changes in plaque index after periodontal treatment.
Baseline and 3 months after
Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter)
Tidsramme: Baseline and 3 months after
The changes in probing pocket depth after periodontal treatment.
Baseline and 3 months after

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Clinical Centre of Kosova

Samarbejdspartnere

University of Ljubljana, Faculty of Medicine

Efterforskere

  • Ledende efterforsker: Dashnor Bukleta, Dr, Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2015

Primær færdiggørelse (Forventet)

1. september 2016

Studieafslutning (Forventet)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

1. august 2016

Først indsendt, der opfyldte QC-kriterier

17. august 2016

Først opslået (Skøn)

22. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUCSK

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

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