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

NCT07791927 | Completed

• 1 other identifier: BaskentU8
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Periodontitis; Gingivitis; Heart Transplant; Systemic Inflammation

Keywords

Non-Surgical Periodontal Therapy; High-Sensitivity C-Reactive Protein; hs-CRP; Heart Transplant Recipients; Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 3 months post-NSPT

Secondary Outcomes (7)

• Change in Plaque Index (PI)

  Baseline and 3 months post-NSPT

• Change in Bleeding on Probing (BOP

  Baseline and 3 months post-NSPT

• Change in Clinical Attachment Level (CAL)

  Baseline and 3 months post-NSPT

• Change in Probing Depth (PD)

  Baseline and 3 months post-NSPT

• Change in Leukocyte Count

  Baseline and 3 months post-NSPT

Study Arms (1)

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.

Procedure: Full-mouth periodontal debridement

Interventions

Full-mouth periodontal debridement PROCEDURE

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

NSPT (Non-Surgical Periodontal Therapy)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baskent University: lead

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Periodontitis; Gingivitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 28, 2026
• Study Start: April 20, 2016
• Primary Completion: May 20, 2018
• Study Completion: June 10, 2019
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share