An observational study in Periodontitis and Periodontal Health, sponsored by Burcu KARADUMAN. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Burcu KARADUMAN · Observational
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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.
1,235 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 108 is above the median of 90 across 372 observational studies indexed under Periodontitis.
Browse Periodontitis studies →This is the only study on the registry with Burcu KARADUMAN as lead sponsor.
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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.
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Exclusion Criteria:
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.
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.
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.
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.
Gingival tissue SAA1 concentration
SAA1 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.
Time frame: Baseline
Gingival tissue SAA2 concentration
SAA2 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.
Time frame: Baseline
Gingival tissue SAA3 concentration
SAA3 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.
Time frame: Baseline
Gingival tissue SAA4 concentration
SAA4 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.
Time frame: Baseline
Correlation Between Gingival Tissue SAA Protein Levels and Probing Depth
Correlation between gingival tissue serum amyloid A (SAA) family protein levels and probing depth, measured in millimeters (mm).
Time frame: Baseline
Correlation Between Gingival Tissue SAA Protein Levels and Plaque Score
Correlation between gingival tissue serum amyloid A (SAA) family protein levels and plaque score, expressed as the percentage, of examined sites with plaque.
Time frame: Baseline
Correlation Between Gingival Tissue SAA Protein Levels and Bleeding on Probing
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.
Time frame: Baseline
Correlation Between Gingival Tissue SAA Protein Levels and Clinical Attachment Level
Correlation between gingival tissue serum amyloid A (SAA) family protein levels and clinical attachment level, measured in millimeters.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Feb 2027, 2 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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