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NCT Number: NCT07691437

Effect of Non-Surgical Periodontal Treatment on Oral Health in Hemophilia Patients

This study aimed to evaluate the effect of non-surgical periodontal treatment (NSPT) on oral health-related quality of life in patients with hemophilia using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. In addition, clinical periodontal parameters and demographic characteristics before and after NSPT were assessed and compared with systemically healthy individuals. A total of 71 patients with hemophilia (60 with Hemophilia A and 11 with Hemophilia B) and 75 healthy individuals were included in the study and grouped according to their periodontal status. Demographic data and oral health-related behavioral characteristics were evaluated. Clinical periodontal parameters and OHIP-14 scores were recorded before treatment and at the sixth week after treatment. All collected data were analyzed statistically. The study aims to determine the relationship between periodontal treatment outcomes and oral health-related quality of life in individuals with hemophilia.

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Key information

Conditions

Hemophilia A and B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia Hemophilia A Hemophilia B Hemorrhagic Disorders Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical University Faculty of Dentistry

Trabzon, 61080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults aged 18 to 64 years.
  • Diagnosis of hemophilia A or hemophilia B (hemophilia group) or systemically healthy individuals/individuals with medically controlled systemic disease (control group).
  • Presence of at least 20 natural teeth, excluding third molars and teeth with orthodontic appliances.
  • Ability to provide written informed consent.
  • Willingness and ability to comply with study procedures

Exclusion criteria

  • Presence of bleeding disorders other than hemophilia A or B.
  • Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus or uncontrolled hypertension).
  • Use of medications known to affect periodontal tissues (e.g., calcium channel blockers, anticonvulsants, or immunosuppressive agents).
  • Fewer than 20 natural teeth.
  • Inability or unwillingness to provide informed consent or comply with study procedures.

Treatment and study plan

Non-surgical periodontal treatment

Procedure

Non-surgical periodontal treatment consisting of oral hygiene instruction, supragingival and subgingival scaling, and root planing performed in a single session. Clinical periodontal parameters and oral health-related quality of life were reassessed 6 weeks after treatment.

Primary outcomes

  1. Oral Health-Related Quality of Life (OHIP-14) Score

    Time frame: Baseline and 6 weeks after treatment

    Change in Oral Health Impact Profile-14 (OHIP-14) score from baseline to 6 weeks after non-surgical periodontal treatment. Higher scores indicate poorer oral health-related quality of life.

Secondary outcomes

  1. Gingival Index (GI)

    Time frame: Baseline and 6 weeks after treatment

    Change in gingival inflammation assessed using the Gingival Index.

  2. Plaque Index (PI)

    Time frame: Baseline and 6 weeks after treatment

    Change in dental plaque accumulation assessed using the Plaque Index.

  3. Bleeding on Probing (BOP)

    Time frame: Baseline and 6 weeks after treatment

    Change in bleeding on probing following non-surgical periodontal treatment.

  4. Probing Pocket Depth (PPD)

    Time frame: Baseline and 6 weeks after treatment

    Change in probing pocket depth measured using a periodontal probe.

  5. Clinical Attachment Level (CAL)

    Time frame: Baseline and 6 weeks after treatment

    Change in clinical attachment level following treatment.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

Evaluation of the Effect of Non-Surgical Periodontal Treatment on Clinical Periodontal Status With Oral Health Impact Profile (OHIP-14) in Patients With Hemophilia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2026
Registry last updated
Jul 8, 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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