Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing (CSTF3PGPSR)
Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
A goal of periodontal diagnostic procedure is to provide useful information to the clinician regarding the present periodontal disease type and severity. Advances in diagnostic research are moving towards methods where periodontal risk can be identified and quantified by objective measures such as Biomarkers.
Trefoil factors (TFFs) are one such secreted molecules derived from mucin producing epithelial cells of the gastro intestinal tracts and other tissues such as Salivary glands, Parotid ducts and oral mucosa. Among three Trefoil factors reported, Trefoil Factor 3 (TFF3) is the modifying factor for signalling pathway involved in cell survival, cell proliferation and cell migration of oral keratinocytes. Hence assessing the marker levels would achieve beneficial effects on diagnosing the disease severity.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
For Gingivitis:
- Gingival Index: 1.1 to 2.
- Modifies Plaque Index: 1.0 to 1.9
For Periodontitis:
- Gingival Index: 1.1 to 2.
- Modifies Plaque Index: 1.0 to 1.9
- Probing depth > 4mm
- Clinical attachment loss > 2mm
Exclusion Criteria:
For Gingivitis:
- Presence of gingival recession.
- Presence of clinical attachment loss.
- Presence of furcation.
- Presence of systemic infections like diabetes, infections.
- Smokers.
- Antibiotic therapy received preceding 3 months.
- Patients who underwent periodontal therapy within 3 months.
- Pregnant and Lactating women.
For Periodontitis:
- Presence of any systemic conditions like diabetes, infections.
- Smokers.
- Antibiotic therapy received preceding 3 months.
- Patients who underwent periodontal therapy within 3 months.
- Pregnant and Lactating women.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental: Interventional
Group A patients consists of Gingivitis patients whose serum is collected at base line and treated with Scaling and root planing and after three months serum is collected for assessment of Trefoil factor 3.
|
After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.
|
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Eksperimentell: Experimental Interventional
Group B patients consists of Periodontitis patients whose serum is collected at base line and treated with Scaling and Root Planing and after three months serum is collected for assessment of Trefoil factor 3.
|
After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Trefoil factor 3
Tidsramme: 3 months.
|
Blood samples were collected by venepuncture of anti-cubital vein.
2ml of blood was collected in each test tube.
10 minutes after collection, the test tube containing 2ml blood was subjected to centrifugation at 3000rpm for 10 min.
The supernatant straw colored fluid (serum) was separated into storage vials (Eppendorf tubes) for serum Trefoil Factor 3.
|
3 months.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the Gingival Index.
Tidsramme: 3 months
|
The severity of gingivitis is scored on all surfaces of selected teeth using Williams Periodontal probe. Index teeth- 16, 12, 24, 36, 32, 44. Score around each tooth is totalled and divided by 4-score of tooth. 0.1-1.0: Mild gingivitis. 1.1-2.0:Moderate gingivitis 2.1-3.0:Severe gingivitis |
3 months
|
|
Change in Modified Plaque Index
Tidsramme: 3 months
|
Examination of all the surfaces of the teeth are done using an explorer. The scores for individual teeth may be grouped and totalled and divided by the number of teeth. Excellent:0 Good:0.1-0.9 Fair:1.0-1.9 Poor:2-3 |
3 months
|
|
Change in Probing depth
Tidsramme: 3 months
|
The distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.
|
3 months
|
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Change in Clinical Attachment loss
Tidsramme: 3 months
|
The distance from the cementoenamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.
|
3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Chaiyarit P, Chayasadom A, Wara-Aswapati N, Hormdee D, Sittisomwong S, Nakaresisoon S, Samson MH, Pitiphat W, Giraud AS. Trefoil factors in saliva and gingival tissues of patients with chronic periodontitis. J Periodontol. 2012 Sep;83(9):1129-38. doi: 10.1902/jop.2011.110431. Epub 2011 Dec 19.
- Storesund T, Schreurs O, Messelt EB, Kolltveit KM, Schenck K. Trefoil factor family 3 expression in the oral cavity. Eur J Oral Sci. 2009 Dec;117(6):636-43. doi: 10.1111/j.1600-0722.2009.00679.x.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Panineeya Mahavidyalaya
- D159206045 (Annen identifikator: Dr.NTR University of Health Sciences)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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