NCT06713928

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

November 27, 2024

Last Update Submit

February 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plaque Control Record (PCR)

    PCR values the presence of dental plaque on the teeth

    1 month

Secondary Outcomes (1)

  • Emotional record

    1 month

Study Arms (2)

Oral hygiene with dog therapy

EXPERIMENTAL

use the DAT to support the oral hygiene procedures provided.

Other: Oral hygiene with dog therapy

Oral hygiene without dog therapy

NO INTERVENTION

make oral hygiene without any type of support

Interventions

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.

Oral hygiene with dog therapy

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with fear of dogs;
  • Patients with dog hair allergy;
  • Patients with infectious disease;
  • Tetraplegic and visually impaired subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza

Torino, 10126, Italy

Location

MeSH Terms

Interventions

Oral Hygiene

Intervention Hierarchy (Ancestors)

HygieneTherapeuticsPreventive DentistryDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dental Hygienist

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 3, 2024

Study Start

December 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 15, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations