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

NCT07691437 | Completed

• 1 other identifier: KTU-DENT-BA-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemophilia A and B; Periodontitis; Hemophilia

Keywords

Hemophilia A; Hemophilia B; Periodontal Disease; Non-Surgical Periodontal Treatment; Oral Health-Related Quality of Life; Quality of Life

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 6 weeks after treatment

Secondary Outcomes (5)

• Gingival Index (GI)

  Baseline and 6 weeks after treatment

• Plaque Index (PI)

  Baseline and 6 weeks after treatment

• Bleeding on Probing (BOP)

  Baseline and 6 weeks after treatment

• Probing Pocket Depth (PPD)

  Baseline and 6 weeks after treatment

• Clinical Attachment Level (CAL)

  Baseline and 6 weeks after treatment

Study Arms (2)

Hemophilia Group

EXPERIMENTAL

Participants diagnosed with hemophilia A or hemophilia B who received non-surgical periodontal treatment, including oral hygiene instruction, supragingival and subgingival scaling, and root planing. Clinical periodontal parameters and oral health-related quality of life (OHIP-14) were evaluated at baseline and 6 weeks after treatment.

Procedure: Non-surgical periodontal treatment

Healthy Control Group

ACTIVE COMPARATOR

Systemically healthy participants who received the same non-surgical periodontal treatment, including oral hygiene instruction, supragingival and subgingival scaling, and root planing. Clinical periodontal parameters and oral health-related quality of life (OHIP-14) were evaluated at baseline and 6 weeks after treatment.

Procedure: Non-surgical periodontal treatment

Interventions

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.

Healthy Control Group; Hemophilia Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University Faculty of Dentistry

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemophilia A; Periodontitis; Hemophilia B; Periodontal Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mouth Diseases; Stomatognathic Diseases; Genetic Diseases, X-Linked

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 8, 2026
• Study Start: March 17, 2021
• Primary Completion: February 25, 2022
• Study Completion: June 23, 2022
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

TU (1)