Oral Hygiene EducationNCT06904963
Efficacy of Oral Hygiene Instructions Carried Out Using an Intra-oral Scanner
A study testing Motivation for oral hygiene through oral scanner in people with Oral Hygiene Education, run by University of Turin, Italy at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oral Hygiene Education
- What is being tested?
- Motivation for oral hygiene through oral scanner
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 17 Feb 2025to 15 May 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 and 80 years
- with good systemic health
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Oral Hygiene Education
- Being tested
- Motivation for oral hygiene through oral scanner
- Keywords
- oral hygiene, Dental scan, Communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivation for oral hygiene through oral scannerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral hygiene instruction with dental scan | Experimental | 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. Receives: Device: Motivation for oral hygiene through oral scanner |
| Traditional oral hygiene instruction | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Plaque Control Record (PCR)
Presence of bacterial plaque on the tooth surface
Measured: at least 62 days
Level of adherence to home oral hygiene procedures and devices
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.
Measured: at least 62 days
Secondary outcomes (2)
Full Mouth Bleeding Score (FMBS)
Percentage of bleeding gums: A higher percentage shows a worse situation of gum inflammation.
Measured: at least 62 days
Level of concordance of home hygiene procedures and devices
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.
Measured: at least 62 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start17 Feb 2025
- Primary completion2 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Hygiene EducationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- NCT06904963
- Sponsor's protocol ID
- 0000620
- Status last verified
- May 2025
- First submitted
- 14 Mar 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36288348Doi 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.
PubMed 34108300Willershausen 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.
PubMed 10858739
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Hygiene Instructions Carried Out Using an Intra-oral Scanner: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06904963
- Acronym / sponsor ID
- 0000620
- Conditions
- Oral Hygiene Education
- Keywords
- oral hygiene, Dental scan, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 1 Apr 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral hygiene instruction with dental scan | Experimental | Device: Motivation for oral hygiene through oral scannerPatients 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. |
| Traditional oral hygiene instruction | No intervention | –Patients are provided with education and motivation for oral hygiene at home in a traditional way, through the use of a simple mirror. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between 18 and 80 years
- with good systemic health
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Motivation for oral hygiene through oral scannerThe oral scanner is used to create a digital model of the patient's mouth with which the operator will provide personalized oral hygiene instructions. | Device | Oral hygiene instruction with dental scan |
Primary outcome
Plaque Control Record (PCR)
Time frame: at least 62 days
Presence of bacterial plaque on the tooth surface
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.
2 secondary outcomes
Full Mouth Bleeding Score (FMBS)
Time frame: at least 62 days
Level of concordance of home hygiene procedures and devices
Time frame: at least 62 days
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 16 May 2025.
- Results publication: PubMed 36288348Jung 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.
- Results publication: PubMed 34108300Doi 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.
- Results publication: PubMed 10858739Willershausen 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.
- Individual participant dataSharing planned: Undecided
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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 Motivation for oral hygiene through oral scanner in people with Oral Hygiene Education, 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 2 inclusion and 3 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 16 May 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: at least 62 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06904963, which also lists 3 linked publications.
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 16 May 2025.