Heart TransplantNCT07791927
Effect of Non-Surgical Periodontal Therapy on Inflammation in Heart Transplant Recipients
A study testing Full-mouth periodontal debridement in people with Heart Transplant and Periodontitis, run by Baskent University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Transplant, Periodontitis, Gingivitis
- What is being tested?
- Full-mouth periodontal debridement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2016to 10 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Effect of Non-Surgical Periodontal Therapy on Systemic Inflammation and Hematological Parameters in Heart Transplant Recipients: A Prospective Study
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.
Read more
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.
Read the detailed description
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).
- Conditions
- Heart Transplant, Periodontitis, Gingivitis, Systemic Inflammation
- Being tested
- Full-mouth periodontal debridement
- Keywords
- Non-Surgical Periodontal Therapy, High-Sensitivity C-Reactive Protein, hs-CRP, Heart Transplant Recipients, Periodontal Disease
- Medical subject headings
- Periodontitis, Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-mouth periodontal debridementProcedure or surgery
Ultrasonic instrumentation and hand curettes used to remove supra- and subgingival plaque and calculus deposits.
| Study group | Role | What they receive |
|---|---|---|
| NSPT (Non-Surgical Periodontal Therapy) | Experimental | Clinically stable heart transplant recipients diagnosed with gingivitis or periodontitis who received non-surgical periodontal therapy (full-mouth debridement plus oral hygiene instruction), with periodontal and systemic inflammatory parameters assessed at baseline and 3 months post-therapy. Receives: Procedure: Full-mouth periodontal debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum high-sensitivity C-reactive protein (hs-CRP)
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
Measured: Baseline and 3 months post-NSPT
Secondary outcomes (7)
Change in Plaque Index (PI)
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
Measured: Baseline and 3 months post-NSPT
Change in Bleeding on Probing (BOP
Measured using a UNC-15 periodontal probe after periodontal pocket measurement .
Unit of Measure: percentage of sites positive for bleeding
Measured: Baseline and 3 months post-NSPT
Change in Clinical Attachment Level (CAL)
Measured using a UNC-15 periodontal probe, before and after NSPT. Unit of Measure: millimeters
Measured: Baseline and 3 months post-NSPT
Change in Probing Depth (PD)
Measured using a UNC-15 periodontal probe, before and after NSPT. Unit of Measure: millimeters
Measured: Baseline and 3 months post-NSPT
Change in Leukocyte Count
Measured using an automated hematology analyzer, before and after NSPT. Unit of Measure: ×10³/µL
Measured: Baseline and 3 months post-NSPT
Change in Hematocrit
Measured using an automated hematology analyzer, before and after NSPT. Unit of Measure: percentage (%)
Measured: Baseline and 3 months post-NSPT
Change in Platelet Count
Measured using an automated hematology analyzer, before and after NSPT. Unit of Measure: ×10³/µL
Measured: Baseline and 3 months post-NSPT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start20 Apr 2016
- Primary completion20 May 2018
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received non-surgical periodontal therapy; periodontal and systemic inflammatory parameters were compared at baseline and 3 months post-therapy within the same group.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Sezgin, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791927
- Sponsor's protocol ID
- BaskentU8
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Kim HC. Epidemiology of cardiovascular disease and its risk factors in Korea. Glob Health Med. 2021;3(3):134-41. 2. Hajishengallis G. Interconnection of periodontal disease and comorbidities: Evidence, mechanisms, and implications. Periodontology 2000. 2022;89(1):9-18. 3. Kapila YL. Oral health's inextricable connection to systemic health: Special populations bring to bear multimodal relationships and factors connecting periodontal disease to systemic diseases and conditions. Periodontology 2000. 2021;87(1):11-6. 4. Weinbecker F, Nahles S, Preißner R, Heiland M, Kernen F, Preißner S. The systemic impact of periodontitis in about 100,000 patients: associations with heart diseases, cancer, and mortality. Clinical Oral Investigations. 2025;30(1):20-. 5. Michalowicz BS, Anderson J, Kottke TE, Dehmer SP, Worley DC, Kane S, et al. Periodontal treatment and subsequent clinical outcomes and medical care costs: A retrospective cohort study. PLoS ONE. 2023;18(8). 6. Church L, Spahr A, Marschner S, Wallace J, Chow CK, King S. Evaluating the impact of oral hygiene instruction and digital oral health education within cardiac rehabilitation clinics: A protocol for a novel, dual centre, parallel randomised controlled trial. PLoS ONE. 2024;19(7). 7. Machado V, Botelho J, Escalda C, Hussain SB, Luthra S, Mascarenhas P, et al. Serum C-Reactive Protein and Periodontitis: A Systematic Review and Meta-Analysis. Frontiers Media; 2021. 8. Sezgin Y, Bulut Ş, Bozalıoğlu S, Sezgin A. Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients With and Without Periodontitis. Experimental and Clinical Transplantation. 2019;17:123-5. 9. Molinsky R, Yuzefpolskaya M, Norby FL, Yu B, Shah AM, Pankow JS, et al. Periodontal Status, C-Reactive Protein, NT-proBNP, and Incident Heart Failure. JACC Heart Failure. 2022;10(10):731-41. 10. Sezgin Y, Alabdullah J. Oral Health in Heart Transplant Recipients: Implications and Strategies. In: Ruaengsri C, Shudo Y, Leon M, editors. Heart Tran
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Periodontal Therapy on Systemic Inflammation and Hematological Parameters in Heart Transplant Recipients: A Prospective Study
- ClinicalTrials.gov ID
- NCT07791927
- Acronym / sponsor ID
- BaskentU8
- Conditions
- Heart Transplant, Periodontitis, Gingivitis, Systemic Inflammation
- Keywords
- Non-Surgical Periodontal Therapy, High-Sensitivity C-Reactive Protein, hs-CRP, Heart Transplant Recipients, Periodontal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 20 Apr 2016 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received non-surgical periodontal therapy; periodontal and systemic inflammatory parameters were compared at baseline and 3 months post-therapy within the same group.
| Arm | Type | Receives |
|---|---|---|
| NSPT (Non-Surgical Periodontal Therapy) | Experimental | Procedure: Full-mouth periodontal debridementClinically stable heart transplant recipients diagnosed with gingivitis or periodontitis who received non-surgical periodontal therapy (full-mouth debridement plus oral hygiene instruction), with periodontal and systemic inflammatory parameters assessed at baseline and 3 months post-therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-mouth periodontal debridementUltrasonic instrumentation and hand curettes used to remove supra- and subgingival plaque and calculus deposits. | Procedure or surgery | NSPT (Non-Surgical Periodontal Therapy) |
Primary outcome
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
7 secondary outcomes
Change in Plaque Index (PI)
Time frame: Baseline and 3 months post-NSPT
Change in Bleeding on Probing (BOP
Time frame: Baseline and 3 months post-NSPT
Change in Clinical Attachment Level (CAL)
Time frame: Baseline and 3 months post-NSPT
Change in Probing Depth (PD)
Time frame: Baseline and 3 months post-NSPT
Change in Leukocyte Count
Time frame: Baseline and 3 months post-NSPT
Change in Hematocrit
Time frame: Baseline and 3 months post-NSPT
Change in Platelet Count
Time frame: Baseline and 3 months post-NSPT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background1. Kim HC. Epidemiology of cardiovascular disease and its risk factors in Korea. Glob Health Med. 2021;3(3):134-41. 2. Hajishengallis G. Interconnection of periodontal disease and comorbidities: Evidence, mechanisms, and implications. Periodontology 2000. 2022;89(1):9-18. 3. Kapila YL. Oral health's inextricable connection to systemic health: Special populations bring to bear multimodal relationships and factors connecting periodontal disease to systemic diseases and conditions. Periodontology 2000. 2021;87(1):11-6. 4. Weinbecker F, Nahles S, Preißner R, Heiland M, Kernen F, Preißner S. The systemic impact of periodontitis in about 100,000 patients: associations with heart diseases, cancer, and mortality. Clinical Oral Investigations. 2025;30(1):20-. 5. Michalowicz BS, Anderson J, Kottke TE, Dehmer SP, Worley DC, Kane S, et al. Periodontal treatment and subsequent clinical outcomes and medical care costs: A retrospective cohort study. PLoS ONE. 2023;18(8). 6. Church L, Spahr A, Marschner S, Wallace J, Chow CK, King S. Evaluating the impact of oral hygiene instruction and digital oral health education within cardiac rehabilitation clinics: A protocol for a novel, dual centre, parallel randomised controlled trial. PLoS ONE. 2024;19(7). 7. Machado V, Botelho J, Escalda C, Hussain SB, Luthra S, Mascarenhas P, et al. Serum C-Reactive Protein and Periodontitis: A Systematic Review and Meta-Analysis. Frontiers Media; 2021. 8. Sezgin Y, Bulut Ş, Bozalıoğlu S, Sezgin A. Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients With and Without Periodontitis. Experimental and Clinical Transplantation. 2019;17:123-5. 9. Molinsky R, Yuzefpolskaya M, Norby FL, Yu B, Shah AM, Pankow JS, et al. Periodontal Status, C-Reactive Protein, NT-proBNP, and Incident Heart Failure. JACC Heart Failure. 2022;10(10):731-41. 10. Sezgin Y, Alabdullah J. Oral Health in Heart Transplant Recipients: Implications and Strategies. In: Ruaengsri C, Shudo Y, Leon M, editors. Heart Tran
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Full-mouth periodontal debridement in people with Heart Transplant and Periodontitis, run by Baskent University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum high-sensitivity C-reactive protein (hs-CRP) (time frame: Baseline and 3 months post-NSPT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07791927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.