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Completed

NCT Number: NCT07791927

Effect of Non-Surgical Periodontal Therapy on Inflammation in Heart Transplant Recipients

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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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically stable heart transplant recipient At least one year post-transplantation Diagnosed with gingivitis or periodontitis requiring non-surgical periodontal therapy (NSPT) No systemic antibiotic use within the preceding six months No periodontal treatment within the previous year

Exclusion criteria

  • Systemic inflammatory or infectious conditions that could independently affect inflammatory marker levels Uncontrolled diabetes mellitus Recent active infection requiring antibiotic therapy Periodontally healthy status (no gingivitis or periodontitis)

Treatment and study plan

Full-mouth periodontal debridement

Procedure

Ultrasonic instrumentation and hand curettes used to remove supra- and subgingival plaque and calculus deposits.

Primary outcomes

  1. Change in serum high-sensitivity C-reactive protein (hs-CRP)

    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

Secondary outcomes

  1. Change in Plaque Index (PI)

    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

  2. Change in Bleeding on Probing (BOP

    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

  3. Change in Clinical Attachment Level (CAL)

    Time frame: Baseline and 3 months post-NSPT

    Measured using a UNC-15 periodontal probe, before and after NSPT. Unit of Measure: millimeters

  4. Change in Probing Depth (PD)

    Time frame: Baseline and 3 months post-NSPT

    Measured using a UNC-15 periodontal probe, before and after NSPT. Unit of Measure: millimeters

  5. Change in Leukocyte Count

    Time frame: Baseline and 3 months post-NSPT

    Measured using an automated hematology analyzer, before and after NSPT. Unit of Measure: ×10³/µL

  6. Change in Hematocrit

    Time frame: Baseline and 3 months post-NSPT

    Measured using an automated hematology analyzer, before and after NSPT. Unit of Measure: percentage (%)

  7. Change in Platelet Count

    Time frame: Baseline and 3 months post-NSPT

    Measured using an automated hematology analyzer, before and after NSPT. Unit of Measure: ×10³/µL

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

Effect of Non-Surgical Periodontal Therapy on Systemic Inflammation and Hematological Parameters in Heart Transplant Recipients: A Prospective Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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