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

10 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

108

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Burcu Karaduman
Numéro de téléphone: +905323763366
E-mail: bkaraduman@gmail.com

Sauvegarde des contacts de l'étude

Nom: Asena Kadayıf Can
Numéro de téléphone: +905382571317
E-mail: asenakadayif@outlook.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: CASE_CONTROL
Perspectives temporelles: CROSS_SECTIONAL

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Gingival tissue SAA1 concentration Délai: 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 Délai: 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 Délai: 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 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Correlation Between Gingival Tissue SAA Protein Levels and Probing Depth Délai: 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 Délai: 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 Délai: 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 Délai: Baseline	Correlation between gingival tissue serum amyloid A (SAA) family protein levels and clinical attachment level, measured in millimeters.	Baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Burcu KARADUMAN

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

4 décembre 2026

Achèvement primaire (Estimé)

4 février 2027

Achèvement de l'étude (Estimé)

4 mars 2027

Dates d'inscription aux études

Première soumission

4 novembre 2026

Première soumission répondant aux critères de contrôle qualité

10 novembre 2026

Première publication (Réel)

13 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)