Hemophilia A and BNCT07691437
Effect of Non-Surgical Periodontal Treatment on Oral Health in Hemophilia Patients
A study testing Non-surgical periodontal treatment in people with Hemophilia A and B and Periodontitis, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemophilia A and B, Periodontitis, Hemophilia
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Mar 2021to 23 Jun 2022
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Faculty of Dentistry
Trabzon, 61080
About this study
Official 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
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
- Being tested
- Non-surgical periodontal treatment
- Keywords
- Hemophilia A, Hemophilia B, Periodontal Disease, Non-Surgical Periodontal Treatment, Oral Health-Related Quality of Life, Quality of Life
- Medical subject headings
- Hemophilia A, Periodontitis, Hemophilia B, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks after treatment
Secondary outcomes (5)
Gingival Index (GI)
Change in gingival inflammation assessed using the Gingival Index.
Measured: Baseline and 6 weeks after treatment
Plaque Index (PI)
Change in dental plaque accumulation assessed using the Plaque Index.
Measured: Baseline and 6 weeks after treatment
Bleeding on Probing (BOP)
Change in bleeding on probing following non-surgical periodontal treatment.
Measured: Baseline and 6 weeks after treatment
Probing Pocket Depth (PPD)
Change in probing pocket depth measured using a periodontal probe.
Measured: Baseline and 6 weeks after treatment
Clinical Attachment Level (CAL)
Change in clinical attachment level following treatment.
Measured: Baseline and 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start17 Mar 2021
- Primary completion25 Feb 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia A and BStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BURAK ALEMDAĞ, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691437
- Sponsor's protocol ID
- KTU-DENT-BA-01
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07691437
- Acronym / sponsor ID
- KTU-DENT-BA-01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 8 Jul 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemophilia Group | Experimental | Procedure: Non-surgical periodontal treatmentParticipants 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. |
| Healthy Control Group | Active comparator | Procedure: Non-surgical periodontal treatmentSystemically 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Non-surgical periodontal treatmentNon-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. | Procedure or surgery | Healthy Control Group, Hemophilia Group |
Primary outcome
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.
5 secondary outcomes
Gingival Index (GI)
Time frame: Baseline and 6 weeks after treatment
Plaque Index (PI)
Time frame: Baseline and 6 weeks after treatment
Bleeding on Probing (BOP)
Time frame: Baseline and 6 weeks after treatment
Probing Pocket Depth (PPD)
Time frame: Baseline and 6 weeks after treatment
Clinical Attachment Level (CAL)
Time frame: Baseline and 6 weeks after treatment
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 8 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment in people with Hemophilia A and B and Periodontitis, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Oral Health-Related Quality of Life (OHIP-14) Score (time frame: Baseline and 6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2026.