Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Evaluation of Gingival Tissue Protein Levels of Serum Amyloid A Family Members

tiistai 10. marraskuuta 2026 päivittänyt: Burcu KARADUMAN

The primary aim of this study is to determine the serum amyloid A (SAA) family protein levels in gingival tissue samples obtained from periodontally healthy and periodontitis patients and to evaluate their relationship with periodontal status. Additionally, the study aims to assess the potential effect of smoking on the amount of SAA proteins in gingival tissue.

Following ethical committee approval, a total of 108 individuals aged 18-65 years who attending to the Department of Periodontology, Biruni University Faculty of Dentistry, will be included in the study. The study groups will consist of 27 non-smoking individuals with periodontally healthy tissue, 27 smoking individuals with periodontally healthy tissue, 27 non-smoking individuals with stage III grade B periodontitis, and 27 smoking individuals with stage III grade C periodontitis. The non-smoking groups will include individuals who have never smoked, while the smoking groups will include individuals who, according to patient statements, have smoked at least 10 cigarettes per day for more than five years.

All participants will be informed about the study and their written consent will be obtained. Plaque score, probing depth, gingival margin position, clinical attachment level, and bleeding on probing will be measured by a calibrated investigator. Gingival tissue samples from periodontally healthy individuals will be collected during planned tooth extraction or periodontal surgical procedures such as gingivoplasty, gingivectomy, or clinical crown lengthening, independent of the study. Only gingival tissues that would otherwise be discarded as medical waste during routine treatment will be used. In individuals with periodontitis, granulation tissue removed during subgingival instrumentation as part of non-surgical periodontal treatment is planned for use. No additional tissue will be removed from the periodontal pocket wall or junctional epithelium for research purposes; the scope of the clinical procedure will not be expanded if suitable tissue cannot be obtained.

Gingival tissue samples will only be collected initially, stored at -80°C until the day of analysis, and evaluated using the ELISA method.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Arvioitu)

108

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Nimi: Burcu Karaduman
Puhelinnumero: +905323763366
Sähköposti: bkaraduman@gmail.com

Tutki yhteystietojen varmuuskopiointi

Nimi: Asena Kadayıf Can
Puhelinnumero: +905382571317
Sähköposti: asenakadayif@outlook.com

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 65 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

Adults aged 18-65 years attending the Department of Periodontology, Faculty of Dentistry, Biruni University, who meet the study eligibility criteria. A total of 108 participants will be included in four groups of 27: periodontally healthy never smokers, periodontally healthy smokers, never smokers with stage III grade B periodontitis, and smokers with stage III grade C periodontitis. Periodontally healthy participants must have an independent clinical indication for tooth extraction or periodontal surgery during which gingival tissue would otherwise be discarded.

Kuvaus

Inclusion Criteria:

Participants must meet the periodontal disease and health criteria,
Be between 18-65 years of age,
Periodontally healthy participants must have an indication for tooth extraction or surgical periodontal treatment where a gingival tissue sample can be collected as part of the treatment plan,
Not have a systemic disease that may affect the pathogenesis of periodontal disease,
Not be pregnant or breastfeeding,
Not be using any medication that may affect the immune system,
Not have used antibiotics or anti-inflammatory drugs in the last 3 months,
Not have received any periodontal treatment in the last 3 months.

Exclusion Criteria:

Having diseases that may affect periodontal tissues, the course of periodontal disease, and the response to periodontal treatment,
Using medications that may affect periodontal tissues, the course of periodontal disease, and the response to periodontal treatment,
Being pregnant or breastfeeding,
Chronic alcohol use,
Using antibiotics or anti-inflammatory drugs within the last 3 months,
Having received periodontal treatment within the last 3 months.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Havaintomallit: CASE_CONTROL
Aikanäkymät: CROSS_SECTIONAL

Ryhmien/kohorttien lukumäärä

Kohortit ja interventiot

Ryhmä/Kohortti
Periodontally Healthy Non-smokers Twenty-seven adults aged 18-65 years who have never smoked, with periodontal health on an intact periodontium, probing depths ≤3 mm, bleeding on probing at <10% of sites, no radiographic bone loss, and no history of periodontal disease.
Periodontally Healthy Smokers Twenty-seven adults aged 18-65 years who report smoking ≥10 cigarettes per day for more than 5 years, with periodontal health on an intact periodontium, probing depths ≤3 mm, bleeding on probing at <10% of sites, no radiographic bone loss, and no history of periodontal disease.
Stage III Grade B Periodontitis Twenty-seven adults aged 18-65 years who have never smoked and have stage III grade B periodontitis. Clinical criteria include clinical attachment loss ≥5 mm at ≥2 nonadjacent teeth, radiographic bone loss extending to the middle third of the root or beyond, loss of ≤4 teeth due to periodontitis, probing depths ≥6 mm, vertical bone loss ≥3 mm, and ≥20 remaining teeth. The percentage radiographic bone loss-to-age ratio will be 0.25-1.0.
Stage III Grade C Periodontitis Twenty-seven adults aged 18-65 years who report smoking ≥10 cigarettes per day for more than 5 years and have stage III grade C periodontitis. Clinical criteria include clinical attachment loss ≥5 mm at ≥2 nonadjacent teeth, radiographic bone loss extending to the middle third of the root or beyond, loss of ≤4 teeth due to periodontitis, probing depths ≥6 mm, vertical bone loss ≥3 mm, and ≥20 remaining teeth. The percentage radiographic bone loss-to-age ratio will be 0.25-1.0; grade C classification will be based on smoking ≥10 cigarettes per day as a grade modifier.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus	Toimenpiteen kuvaus	Aikaikkuna
Gingival tissue SAA1 concentration Aikaikkuna: Baseline	SAA1 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.	Baseline
Gingival tissue SAA2 concentration Aikaikkuna: Baseline	SAA2 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.	Baseline
Gingival tissue SAA3 concentration Aikaikkuna: Baseline	SAA3 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.	Baseline
Gingival tissue SAA4 concentration Aikaikkuna: Baseline	SAA4 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.	Baseline

Toissijaiset tulostoimenpiteet

Tulosmittaus	Toimenpiteen kuvaus	Aikaikkuna
Correlation Between Gingival Tissue SAA Protein Levels and Probing Depth Aikaikkuna: Baseline	Correlation between gingival tissue serum amyloid A (SAA) family protein levels and probing depth, measured in millimeters (mm).	Baseline
Correlation Between Gingival Tissue SAA Protein Levels and Plaque Score Aikaikkuna: Baseline	Correlation between gingival tissue serum amyloid A (SAA) family protein levels and plaque score, expressed as the percentage, of examined sites with plaque.	Baseline
Correlation Between Gingival Tissue SAA Protein Levels and Bleeding on Probing Aikaikkuna: Baseline	Correlation between gingival tissue serum amyloid A (SAA) family protein levels and bleeding on probing, expressed as the percentage of examined sites exhibiting bleeding after probing.	Baseline
Correlation Between Gingival Tissue SAA Protein Levels and Clinical Attachment Level Aikaikkuna: Baseline	Correlation between gingival tissue serum amyloid A (SAA) family protein levels and clinical attachment level, measured in millimeters.	Baseline

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Burcu KARADUMAN

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Perjantai 4. joulukuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Torstai 4. helmikuuta 2027

Opintojen valmistuminen (Arvioitu)

Torstai 4. maaliskuuta 2027

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 4. marraskuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 10. marraskuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Perjantai 13. marraskuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)