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

2026. november 10. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

108

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Név: Burcu Karaduman
Telefonszám: +905323763366
E-mail: bkaraduman@gmail.com

Tanulmányozza a kapcsolattartók biztonsági mentését

Név: Asena Kadayıf Can
Telefonszám: +905382571317
E-mail: asenakadayif@outlook.com

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Megfigyelési modellek: CASE_CONTROL
Időperspektívák: CROSS_SECTIONAL

Csoportok/kohorszok száma

Kohorszok és beavatkozások

Csoport / Kohorsz
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Gingival tissue SAA1 concentration Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Correlation Between Gingival Tissue SAA Protein Levels and Probing Depth Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: Baseline	Correlation between gingival tissue serum amyloid A (SAA) family protein levels and clinical attachment level, measured in millimeters.	Baseline

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Burcu KARADUMAN

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. december 4.

Elsődleges befejezés (Becsült)

2027. február 4.

A tanulmány befejezése (Becsült)

2027. március 4.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. november 4.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 10.

Első közzététel (Tényleges)

2026. november 13.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)