- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06904963
Efficacy of Oral Hygiene Instructions Carried Out Using an Intra-oral Scanner
Efficacy of Oral Hygiene Instructions Carried Out Using an Intra-oral Scanner: a Randomized Controlled Trial
In the relationship between the dental hygienist and the patient, communication plays a key role in ensuring the quality of care, the patient's well-being, and adherence to oral hygiene recommendations. The professional must therefore consider the challenges and limitations of effective communication.
The dental hygienist is a healthcare professional who plays a crucial role in the prevention and promotion of oral health. These specialists assist and educate patients on oral hygiene practices. In order to communicate effectively, especially in today's modern society, it is essential to use increasingly advanced communication tools. The hygienist's task is to explore new technologies and communication methods to motivate patients.
Through empathetic, respectful, and personalized communication, a lasting relationship is often established between the hygienist and the patient. This is because their interactions are generally more frequent than those between the patient and the dentist. While professional oral hygiene sessions are recommended at least once a year for everyone, "fragile" patients-those with periodontal disease or other conditions-may require more frequent visits.
In everyday practice, it has been observed that patients tend to feel more comfortable discussing their doubts, concerns, and issues with dental hygienists rather than with dentists.
To achieve effective communication, various communication methods may be necessary. It will be interesting to determine whether technology can become a useful tool in dental hygienists' practice and positively influence patients' oral hygiene with long-lasting effects.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Torino, Italy, 10126
- AOU Città della Salute e della Scienza
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- between 18 and 80 years
- with good systemic health
Exclusion Criteria:
- Patients with conditions related to increased gingival bleeding
- Patients on drug therapy related to increased gingival bleeding
- Patients with cognitive and/or manual and/or sensory deficits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Oral hygiene instruction with dental scan
Patients are provided with education and motivation for home oral hygiene through the use of an intraoral scanner (Mach 2 - Mech & Human) with the creation of a digital model and with the aim of improving operator-patient communication.
|
The oral scanner is used to create a digital model of the patient's mouth with which the operator will provide personalized oral hygiene instructions.
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No Intervention: Traditional oral hygiene instruction
Patients are provided with education and motivation for oral hygiene at home in a traditional way, through the use of a simple mirror.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque Control Record (PCR)
Time Frame: at least 62 days
|
Presence of bacterial plaque on the tooth surface
|
at least 62 days
|
|
Level of adherence to home oral hygiene procedures and devices
Time Frame: at least 62 days
|
Evaluation of how well the patient follows the recommended home oral hygiene indications.
The operator will give an evaluation from 1 (no adherence: the patient has not adopted the indications provided during the previous session) to 5 (total adherence: the patient has successfully adopted all the indications provided in the previous session) of the adherence demonstrated by the patient to the use of the devices and techniques of home oral hygiene.
|
at least 62 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Full Mouth Bleeding Score (FMBS)
Time Frame: at least 62 days
|
Percentage of bleeding gums: A higher percentage shows a worse situation of gum inflammation.
|
at least 62 days
|
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Level of concordance of home hygiene procedures and devices
Time Frame: at least 62 days
|
Evaluation of how much the patient feels involved in the recommended home oral hygiene indications.
The operator will give an evaluation from 1 (no concordance: the patient feels minimally involved in the procedures aimed at improving his home oral hygiene) to 5 (total concordance: the patient feels involved in all the procedures aimed at improving his home oral hygiene) of the concordance reported by the patient on the home oral hygiene procedures provided.
|
at least 62 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jung K, Giese-Kraft K, Fischer M, Schulze K, Schlueter N, Ganss C. Visualization of dental plaque with a 3D-intraoral-scanner-A tool for whole mouth planimetry. PLoS One. 2022 Oct 26;17(10):e0276686. doi: 10.1371/journal.pone.0276686. eCollection 2022.
- Doi K, Yoshiga C, Kobatake R, Kawagoe M, Wakamatsu K, Tsuga K. Use of an intraoral scanner to evaluate oral health. J Oral Sci. 2021 Jun 29;63(3):292-294. doi: 10.2334/josnusd.21-0048. Epub 2021 Jun 9.
- Willershausen B, Schlosser E, Ernst CP. The intra-oral camera, dental health communication and oral hygiene. Int Dent J. 1999 Apr;49(2):95-100. doi: 10.1111/j.1875-595x.1999.tb00515.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0000620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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