DisabilitiesNCT06713928
Effectiveness of Dog-Assisted Therapy on Compliance and Home Oral Hygiene Activities in Disabled Patients
A study testing Oral hygiene with dog therapy in people with Disabilities and Dog Therapy, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Recent scientific studies have shown how interaction with an animal can alleviate particular conditions of stress and conflict, thus representing a solid support for minor patients with social behavior problems or with physical or mental disabilities. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Disabilities, Dog Therapy, Oral Hygiene, Oral Health
- What is being tested?
- Oral hygiene with dog therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 15 Feb 2025
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients had to be between 5 and 16 years old;
- Patients with disability;
- Non-collaborating or with limited collaboration (Frankl Scale 1 or 2);
- Patients with a Plaque Control Record (PCR) of 40% or more;
- Patients with partial autonomy in home oral hygiene procedures.
Who cannot join
- Patients with fear of dogs;
- Patients with dog hair allergy;
- Patients with infectious disease;
- Tetraplegic and visually impaired subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Recent scientific studies have shown how interaction with an animal can alleviate particular conditions of stress and conflict, thus representing a solid support for minor patients with social behavior problems or with physical or mental disabilities. In this co-therapy, a fundamental role is played by the relationship that is established between the human being and the animal, a very particular relationship capable of bringing about positive changes, in both members, but especially in the man who, benefiting from this push for change, can improve his own situation, whatever it is, and follow with greater interest and involvement the actual therapy activities proposed by the team that is following him.
- Conditions
- Disabilities, Dog Therapy, Oral Hygiene, Oral Health
- Being tested
- Oral hygiene with dog therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene with dog therapyOther
The DAT session is divided into two phases: a pre-sitting phase in which the patient could interact with the dog, touching, caressing and playing with him, under the supervision of the dog-trainer. This phase lasted about 15 minutes. The second phase was a during-sitting phase in which the dog was in the chair, next to the patient, during the entire oral hygiene procedure, under the supervision of the dog-trainer.
| Study group | Role | What they receive |
|---|---|---|
| Oral hygiene with dog therapy | Experimental | use the DAT to support the oral hygiene procedures provided. Receives: Other: Oral hygiene with dog therapy |
| Oral hygiene without dog therapy | No intervention | make oral hygiene without any type of support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Control Record (PCR)
PCR values the presence of dental plaque on the teeth
Measured: 1 month
Secondary outcomes (1)
Emotional record
the patient's perception was recorded using a graphic card that represents the moods of the moment of oral hygiene session
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Dec 2024
- Primary completion1 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisabilitiesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacopo Lanzetti, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713928
- Sponsor's protocol ID
- 0000793
- Status last verified
- Feb 2025
- First submitted
- 27 Nov 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dog-Assisted Therapy on Compliance and Home Oral Hygiene Activities in Disabled Patients
- ClinicalTrials.gov ID
- NCT06713928
- Acronym / sponsor ID
- 0000793
- Conditions
- Disabilities, Dog Therapy, Oral Hygiene, Oral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 3 Dec 2024 (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.
Recent scientific studies have shown how interaction with an animal can alleviate particular conditions of stress and conflict, thus representing a solid support for minor patients with social behavior problems or with physical or mental disabilities. In this co-therapy, a fundamental role is played by the relationship that is established between the human being and the animal, a very particular relationship capable of bringing about positive changes, in both members, but especially in the man who, benefiting from this push for change, can improve his own situation, whatever it is, and follow with greater interest and involvement the actual therapy activities proposed by the team that is following him.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral hygiene with dog therapy | Experimental | Other: Oral hygiene with dog therapyuse the DAT to support the oral hygiene procedures provided. |
| Oral hygiene without dog therapy | No intervention | –make oral hygiene without any type of support |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients had to be between 5 and 16 years old;
- Patients with disability;
- Non-collaborating or with limited collaboration (Frankl Scale 1 or 2);
- Patients with a Plaque Control Record (PCR) of 40% or more;
- Patients with partial autonomy in home oral hygiene procedures.
Key exclusion criteria (4 listed)
- Patients with fear of dogs;
- Patients with dog hair allergy;
- Patients with infectious disease;
- Tetraplegic and visually impaired subjects.
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 |
|---|---|---|
| Oral hygiene with dog therapyThe DAT session is divided into two phases: a pre-sitting phase in which the patient could interact with the dog, touching, caressing and playing with him, under the supervision of the dog-trainer. This phase lasted about 15 minutes. The second phase was a during-sitting phase in which the dog was in the chair, next to the patient, during the entire oral hygiene procedure, under the supervision of the dog-trainer. | Other | Oral hygiene with dog therapy |
Primary outcome
Plaque Control Record (PCR)
Time frame: 1 month
PCR values the presence of dental plaque on the teeth
1 secondary outcome
Emotional record
Time frame: 1 month
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 20 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Disabilities
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effect of Kendall Versus McKenzie Exercises in Patients With Upper Crossed Syndrome
Upper Crossed Syndrome
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
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 Oral hygiene with dog therapy in people with Disabilities and Dog Therapy, run by University of Turin, Italy at 1 site in Italy.
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 4 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 20 Feb 2025. 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 Italy. 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?
Plaque Control Record (PCR) (time frame: 1 month). 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 20 Feb 2025.