Full-mouth periodontal debridement
ProcedureUltrasonic instrumentation and hand curettes used to remove supra- and subgingival plaque and calculus deposits.
NCT Number: NCT07791927
Heart transplant recipients frequently exhibit chronic low-grade systemic inflammation, which can contribute to allograft dysfunction and cardiovascular complications. Periodontitis, a chronic inflammatory disease of the tooth-supporting tissues, is a modifiable but often overlooked source of this inflammatory burden.
This prospective study evaluated whether non-surgical periodontal therapy (NSPT) - comprising full-mouth debridement and oral hygiene instruction - could reduce systemic inflammatory markers in clinically stable heart transplant recipients.
Adults who had undergone heart transplantation at least one year earlier and presented with gingivitis or periodontitis underwent a comprehensive periodontal examination and blood sampling for high-sensitivity C-reactive protein (hs-CRP), leukocyte count, hematocrit, and platelet count. Participants then received NSPT, with periodontal and hematological parameters reassessed three months later.
Findings from this study may clarify whether periodontal therapy represents a useful adjunctive strategy for reducing systemic inflammatory burden in this medically complex population.
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Interventional
Not applicable
This prospective interventional study evaluated the effect of non-surgical periodontal therapy (NSPT) on clinical periodontal parameters and systemic inflammatory markers in clinically stable heart transplant recipients. It was conducted as a follow-on to a previously published cross-sectional study by the same group, which demonstrated elevated hs-CRP levels in heart transplant recipients with periodontitis compared with periodontally healthy recipients and those with gingivitis.
Eligible participants were heart transplant recipients at least one year post-transplantation, clinically stable, and diagnosed with gingivitis or periodontitis requiring NSPT. Participants were excluded if they had received systemic antibiotics within the preceding six months, had undergone periodontal treatment within the previous year, or presented with systemic inflammatory or infectious conditions that could independently confound inflammatory marker levels (e.g., uncontrolled diabetes mellitus, active infection requiring antibiotic therapy).
At baseline, a calibrated periodontist performed a comprehensive periodontal examination using a UNC-15 periodontal probe, recording plaque index (PI), bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL). Periodontal diagnoses were assigned according to the current classification of periodontal and peri-implant diseases and conditions. Fasting venous blood samples were collected for measurement of serum hs-CRP, leukocyte count, hematocrit, and platelet count.
All participants subsequently received NSPT, consisting of full-mouth debridement with ultrasonic instrumentation and hand curettes, together with professional oral hygiene instruction. Periodontal and hematological parameters were reassessed three months after completion of therapy.
Of 33 heart transplant recipients initially assessed for eligibility, 30 met inclusion criteria, 20 consented to participate and underwent NSPT, and 17 completed the 3-month follow-up and were included in the final analysis.
Statistical analyses were performed using Python (SciPy, pandas). Normality of within-patient difference scores was assessed with the Shapiro-Wilk test; paired-samples t-tests (Cohen's d) were applied where differences were approximately normally distributed, and Wilcoxon signed-rank tests (effect size r) were used otherwise. Between-group delta comparisons employed independent-samples t-tests or Mann-Whitney U tests. Statistical significance was set at p < 0.05 (two-tailed).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasonic instrumentation and hand curettes used to remove supra- and subgingival plaque and calculus deposits.
Time frame: Baseline and 3 months post-NSPT
Serum hs-CRP levels measured at baseline and 3 months following non-surgical periodontal therapy (NSPT), compared within the same group of heart transplant recipients. Unit of Measure: mg/L
Time frame: Baseline and 3 months post-NSPT
Assessed on tooth surfaces using the Silness-Löe Plaque Index, scored via visual and tactile examination.
Unit of Measure: score 0-3 for based on the amount of plaque
Time frame: Baseline and 3 months post-NSPT
Measured using a UNC-15 periodontal probe after periodontal pocket measurement .
Unit of Measure: percentage of sites positive for bleeding
Time frame: Baseline and 3 months post-NSPT
Measured using a UNC-15 periodontal probe, before and after NSPT. Unit of Measure: millimeters
Time frame: Baseline and 3 months post-NSPT
Measured using a UNC-15 periodontal probe, before and after NSPT. Unit of Measure: millimeters
Time frame: Baseline and 3 months post-NSPT
Measured using an automated hematology analyzer, before and after NSPT. Unit of Measure: ×10³/µL
Time frame: Baseline and 3 months post-NSPT
Measured using an automated hematology analyzer, before and after NSPT. Unit of Measure: percentage (%)
Time frame: Baseline and 3 months post-NSPT
Measured using an automated hematology analyzer, before and after NSPT. Unit of Measure: ×10³/µL
Baskent University
Other
Effect of Non-Surgical Periodontal Therapy on Systemic Inflammation and Hematological Parameters in Heart Transplant Recipients: A Prospective Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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