PeriodontitisPERIORISKNCT05078411
Efficacy of Periodontal Risk Communication in Patients With and Without History of Tooth Loss
A study testing Test treatment in people with Periodontitis and Periodontal Diseases, run by Università degli Studi di Ferrara at 2 sites in Italy.
Trial summary
SCIENTIFIC BACKGROUND The periodontal risk assessment method proposed by the University of Ferrara (namely, the PerioRisk; Trombelli et al. 2009) has been retrospectively validated and has been shown as a promising tool for tailoring supportive periodontal care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontal Diseases, Communication
- What is being tested?
- Test treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Dec 2021to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- possessing a recent (i.e., performed within 24 months) bidimensional radiograph (orthopantomography or periapical status) or programmed to perform the radiographic exam;
- speaking Italian fluently.
Who cannot join
- history of a previous periodontal diagnosis;
- conditions (es. psychiatric diseases, alcohol abuse) or drug exposures (e.g., antidepressants) that may influence the results of psychological questionnaires;
- lack of a recent (i.e., performed within 24 months) bidimensional radiograph and not able/willing to provide the exam (e..g., due to pregnancy);
- not presenting at two programmed study visits consecutively;
- pre-treatment HADS score indicative of clinical depression.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Operative Unit of Dentistry, Azienda Unità Sanitaria Locale (AUSL)
Ferrara, 44121
Section of Dentistry, University of Ferrara
Ferrara, 44121
About this study
Official title: Efficacy of Periodontal Risk Communication on Awareness and Propensity to Undergo the Suggested Treatments in Patients With and Without History of Tooth Loss Due to Periodontitis
SCIENTIFIC BACKGROUND The periodontal risk assessment method proposed by the University of Ferrara (namely, the PerioRisk; Trombelli et al. 2009) has been retrospectively validated and has been shown as a promising tool for tailoring supportive periodontal care. No information on its efficacy on psychological outcomes, however, is currently available.
AIMS The primary aim of the study is to evaluate the efficacy of communicating periodontal risk level (as assessed with the PerioRisk tool) on psychological outcomes (i.e, patient consciousness and propensity to adhere to treatment instructions) in subjects who have been programmed for first periodontal consultation. The secondary aims of the study are (i) to comparatively evaluate the level of consciousness and propensity to adhere to treatment instructions in patients without a history of tooth loss due to periodontitis (as evaluated after communication of their periodontal risk level) and patients with a history of tooth loss due to periodontitis (as evaluated before their periodontal consultation); and (ii) to comparatively evaluate oral hygiene levels in patients who have received information on their diagnosis, treatment plan, oral hygiene instructions and treatment goals with or without the support of PerioRisk.
Read more
MATERIALS \& METHODS Eighty patients (40 without a history of tooth loss due to periodontitis, NTLP; 40 with a history of tooth loss due to periodontitis, TLP) will be recruited at 2 centers and randomly assigned to receive test or control treatment. Therefore, each of the two treatment groups (test and control) will incorporate two subgroups (NTLP and TLP) of 20 patients each.
For each participant, the experimental phase of the study will consist of three observation intervals: T0 (verification of the eligibility criteria, patient allocation to treatment; T1 (performed within 3 months from T0 for assessment of clinical parameters, treatment administration, and administration of questionnaires before and after treatment; T2 (performed at 8-12 weeks after T1 for the assessment of clinical parameters).
At T1, following routine periodontal clinical assessment and questionnaire completion, patients will receive test or control treatment according to the randomization list. Test treatment will consist of a single session structured as follows: (i) information on periodontal diagnosis; (ii) information on periodontal risk level (as calculated with the PerioRisk tool) and profile (i.e., the magnitude of the contribution of each PerioRisk parameter to generate the patient risk level); (iii) information on treatment plan and oral hygiene instructions, with emphasis to treatment goals based on the PerioRisk output. Control treatment will consist in a single session structured as follows: (i) information on periodontal diagnosis; (ii) information on treatment plan and oral hygiene instructions, and treatment goals. Although the general concept of risk of periodontitis incidence/progression will be explained, no mention will be made to the patient risk level (as calculated with PerioRisk or any other tool) when administering control treatment. Two operators will be trained to administer test and control treatments in approximately 8', but time for treatment administration will be extended for additional questions and answers whenever needed by the patient. Total time for treatment administration will be recorded.
Patients will be administered the following battery of psychological questionnaires: (i) Positive Affect Negative Affect Scale (PANAS) (Watson et al. 1988); (ii) Protection Motivation Theory (PMT) questionnaire (Conner \& Norman 2005); (iii) Hospital Anxiety and Depression Scale (HADS-A/D) (Zigmond \& Snaith 1983). While HADS-A/D will be used to screen out patients with clinical anxiety/ depression before treatment administration, PANAS and PMT will be completed either immediately before and immediately after treatment administration.
Read the detailed description
SCIENTIFIC BACKGROUND The standardized application of the same protocols (for intensity, modality, and monitoring) for primary and secondary prevention of periodontitis as well as for the active treatment phase itself will rarely meet the individual's needs, resulting in under-provision of care to some and over-provision to others, with unwanted side effects and suboptimal allocation of resources. To deliver personalized and precision periodontal care, risk assessment should be incorporated in the periodontal evaluation as a third dimension, to comprehensively assess and interpret factors that may have an impact on future disease onset or progression and upon a patient's anticipated response to periodontal treatment. Previous studies showed that patients receiving information on individual periodontal risk level had significantly higher consciousness of disease seriousness and significantly higher intention to adhere to treatment instructions after consultation. These findings support the use of this system in clinical practice and obtain greater patient adherence to the suggested preventive and treatment protocols. Although the periodontal risk assessment method proposed by the University of Ferrara (namely, the PerioRisk) has been retrospectively validated and has been shown as a promising tool for tailoring supportive periodontal care, no information on its efficacy on psychological outcomes is currently available.
AIM Primary aim: to evaluate the efficacy of communicating periodontal risk level (as assessed with the PerioRisk tool) on psychological outcomes (i.e, patient consciousness and propensity to adhere to treatment instructions) in subjects who have been programmed for first periodontal consultation.
Expected result (primary aim): when communicating information on periodontal diagnosis, periodontal treatment plan, oral hygiene instructions and periodontal treatment goals to the patient undergoing first periodontal consultation, the adjunctive use of the PerioRisk tool will result in significantly increased levels of patient consciousness and propensity to adhere to treatment instructions.
Secondary aim #1: to comparatively evaluate the level of consciousness and propensity to adhere to treatment instructions in (i) patients without a history of tooth loss due to periodontitis (as evaluated after communication of their periodontal risk level) and (ii) patients with a history of tooth loss due to periodontitis (as evaluated before their periodontal consultation).
Expected result (secondary aim #1): in subjects without a history of tooth loss due to periodontitis, the adjunctive use of the PerioRisk tool during first periodontal consultation will improve patient consciousness and propensity to adhere to treatment instructions up to levels that are reached with periodontitis-associated tooth loss.
Secondary aim 2: to comparatively evaluate oral hygiene levels in patients who have received information on their diagnosis, treatment plan, oral hygiene instructions and treatment goals with or without the support of PerioRisk during their consultation.
Expected result (secondary aim #2): at a distance of 8-12 weeks from consultation, greater improvements in full-mouth Plaque Index will be observed in patients who have received information on their diagnosis, treatment plan, oral hygiene instructions and treatment goals with the support of the PerioRisk tool.
EXPERIMENTAL DESIGN The study is designed as a multicenter, single-blind, parallel-arm, randomized trial.
MATERIALS \& METHODS Participating clinical centers Participants will be recruited at 2 centers: (i) Section of Dentistry, University of Ferrara; and (ii) Operative Unit of Dentistry, Azienda Unità Sanitaria Locale of Ferrara, Italy.
Study population Specific inclusion and exclusion criteria will be used to recruit adult patients programmed for their first periodontal consultation. Patient selection will ensure a balanced distribution (1:1 ratio) of patients with and without a history of tooth loss due to periodontitis (Tooth Loss due to Periodontitis, TLP group; and No Tooth Loss due to Periodontitis, NTLP group).
Sample size Based on data from the study by Asimakopoulou et al. (2015), a per-protocol study of 62 patients will be sufficient to detect a significant inter-group difference in the primary outcome measure (i.e., patient propensity to adhere to treatment instructions) with a two-sided test at a p-level of 0.05 and a statistical power of 80%. An intention-to-treat population of 80 patients (40 allocated to test treatment, 40 allocated to control treatment) will be used for the study.
Observation intervals
For each participant, the experimental phase of the study will consist of three observation intervals:
T0 (screening visit): verification of the eligibility criteria, patient allocation to treatment; T1 (within 3 months from T0): assessment of clinical parameters; treatment administration; administration of questionnaires before and after treatment; T2 (8-12 weeks after T1): assessment of clinical parameters.
Experimental treatments and patient allocation to treatment Following routine periodontal clinical assessment and questionnaire completion (see study parameters for details), patients will receive test treatment (RISK) or control treatment (TaU) according to the randomization list (as created using a random digit generator). Before the study, two operators (A.S. and M.E.G.) will be trained to administer RISK or TaU in approximately 8 minutes. The patient will be left free to interrupt the session for questions, if needed. Only the operator and the patient will be present in the operating room during treatment administration. Whenever needed by the patient, time for treatment administration will be extended for additional questions and answers. Total time for treatment administration will be recorded.
Statistical methods Non-parametric two-sided statistical tests will be used for intra-group comparisons (i.e., pre- vs post-treatment administration; Wilcoxon paired samples test) and inter-group comparisons (i.e., RISK vs TaU and TLP vs NTLP; Mann-Whitney U-test) for scores obtained from the psychological questionnaires. Cronbach's alpha will be calculated for the PMT scale overall to assess internal consistency.
- Conditions
- Periodontitis, Periodontal Diseases, Communication
- Being tested
- Test treatment, Control treatment
- Keywords
- periodontitis, periodontal diseases, prognosis, risk assessment, risk factor, communication, consciousness, propensity
- Medical subject headings
- Periodontitis, Periodontal Diseases, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test treatmentBehavioural
Also called Periodontal risk assessment
Test treatment will consist of a single session structured as follows: (i) information on periodontal diagnosis (as formulated according to the classification system of the 2017 World Workshop for the Classification of Periodontal Diseases and Conditions); (ii) information on periodontal risk level (as calculated with the PerioRisk tool proposed by Trombelli et al. 2009) and profile (i.e., the magnitude of the contribution of each PerioRisk parameter to generate the patient risk level); (iii) information on treatment plan and oral hygiene instructions, with emphasis to treatment goals based on the PerioRisk output.
The operators will be trained to administer test treatment in approximately 8 minutes, but the duration of the session will be extended for additional questions and answers upon patient request.
Control treatmentBehavioural
Also called Treatment as usual
Control treatment will consist in a single session structured as follows: (i) information on periodontal diagnosis (as formulated according to the classification system of the 2017 World Workshop for the Classification of Periodontal Diseases and Conditions); (ii) information on treatment plan and oral hygiene instructions, and treatment goals. Although the general concept of risk of periodontitis incidence/progression will be explained, no mention will be made to the patient risk level as calculated with PerioRisk or any other tool.
The operators will be trained to administer control treatment in approximately 8 minutes, but the duration of the session will be extended for additional questions and answers upon patient request.
| Study group | Role | What they receive |
|---|---|---|
| Patients without a history of tooth loss due to periodontitis (NTLP) | Other | Not described Receives: Behavioral: Test treatment; Behavioral: Control treatment |
| Patients with a history of tooth loss due to periodontitis (TLP) | Other | Not described Receives: Behavioral: Test treatment; Behavioral: Control treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propensity to adhere to treatment instructions over the next 8-12 weeks
The outcome consists of the mean post-treatment change in the patient-related score related to the item "Intention" of the Protection Motivation Theory (PMT) questionnaire (Conner \& Norman 2005). The score can range on a scale from 1 to 10, with higher scores indicating a better outcome (i.e., greater propensity to adhere to treatment instructions).
Measured: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Secondary outcomes (8)
Mean change in the score related to "Positive emotions"
The outcome consists of the mean post-treatment change in the patient-related score related to the item "Positive emotions" of the Positive Affect Negative Affect Scale (PANAS) (Watson et al. 1988). The score can range on a scale from 10 to 50, with higher scores representing higher levels of positive affect.
Measured: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Negative emotions"
The outcome consists of the mean post-treatment change in the patient-related score related to the item "Negative emotions" of the Positive Affect Negative Affect Scale (PANAS) (Watson et al. 1988). The score can range on a scale from 10 to 50, with lower scores representing lower levels of negative affect.
Measured: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Seriousness"
The outcome consists of the mean post-treatment change in the patient-related score related to the item "Seriousness" of the Protection Motivation Theory (PMT) questionnaire (Conner \& Norman 2005). The scores can range on a scale from 1 to 10, with higher scores indicating a better outcome.
Measured: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Susceptibility"
The outcome consists if the mean post-treatment change in the patient-related score related to the item "Susceptibility" of the Protection Motivation Theory (PMT) questionnaire (Conner \& Norman 2005). The scores can range on a scale from 1 to 10, with higher scores indicating a better outcome.
Measured: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Treatment effectiveness"
The outcome consists of the mean post-treatment change in the patient-related score related to the item "Treatment effectiveness" of the Protection Motivation Theory (PMT) questionnaire (Conner \& Norman 2005). The scores can range on a scale from 1 to 10, with higher scores indicating a better outcome.
Measured: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Self-efficacy"
The outcome consists if the mean post-treatment change in the patient-related score related to the item "Self-efficacy" of the Protection Motivation Theory (PMT) questionnaire (Conner \& Norman 2005). The scores can range on a scale from 1 to 10, with higher scores indicating a better outcome.
Measured: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Treatment barriers"
The outcome consists of the mean post-treatment change in the patient-related score related to the item "Treatment barriers" of the Protection Motivation Theory (PMT) questionnaire (Conner \& Norman 2005). The scores can range on a scale from 1 to 10, with lower scores indicating a better outcome.
Measured: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Fear"
The outcome consists of the mean post-treatment change in the patient-related score related to the item "Fear" of the Protection Motivation Theory (PMT) questionnaire (Conner \& Norman 2005). The scores can range on a scale from 1 to 10, with higher scores indicating a better outcome.
Measured: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Dec 2021
- Primary completion31 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a multicenter, single-blind, parallel-arm, randomized trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Trombelli, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078411
- Sponsor's protocol ID
- PERIORISK
- Acronym
- PERIORISK
- Status last verified
- Mar 2025
- First submitted
- 17 Sep 2021
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farina R, Simonelli A, Guarnelli ME, Secchiati G, Montemezzo G, Scapoli C, Trombelli L. Efficacy of communicating periodontal risk on psychological outcomes and supragingival plaque control in patients undergoing first periodontal consultation: A parallel-arm, randomized trial. J Clin Periodontol. 2024 Oct;51(10):1289-1301. doi: 10.1111/jcpe.14032. Epub 2024 Jul 2.
PubMed 38956317
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Periodontal Risk Communication on Awareness and Propensity to Undergo the Suggested Treatments in Patients With and Without History of Tooth Loss Due to Periodontitis
- ClinicalTrials.gov ID
- NCT05078411
- Acronym / sponsor ID
- PERIORISK / PERIORISK
- Conditions
- Periodontitis, Periodontal Diseases, Communication
- Keywords
- periodontitis, periodontal diseases, prognosis, risk assessment, risk factor, communication, consciousness, propensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Oct 2021 (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.
SCIENTIFIC BACKGROUND The periodontal risk assessment method proposed by the University of Ferrara (namely, the PerioRisk; Trombelli et al. 2009) has been retrospectively validated and has been shown as a promising tool for tailoring supportive periodontal care. No information on its efficacy on psychological outcomes, however, is currently available.
AIMS The primary aim of the study is to evaluate the efficacy of communicating periodontal risk level (as assessed with the PerioRisk tool) on psychological outcomes (i.e, patient consciousness and propensity to adhere to treatment instructions) in subjects who have been programmed for first periodontal consultation. The secondary aims of the study are (i) to comparatively evaluate the level of consciousness and propensity to adhere to treatment instructions in patients without a history of tooth loss due to periodontitis (as evaluated after communication of their periodontal risk level) and patients with a history of tooth loss due to periodontitis (as evaluated before their periodontal consultation); and (ii) to comparatively evaluate oral hygiene levels in patients who have received information on their diagnosis, treatment plan, oral hygiene instructions and treatment goals with or without the support of PerioRisk.
MATERIALS \& METHODS Eighty patients (40 without a history of tooth loss due to periodontitis, NTLP; 40 with a history of tooth loss due to periodontitis, TLP) will be recruited at 2 centers and randomly assigned to receive test or control treatment. Therefore, each of the two treatment groups (test and control) will incorporate two subgroups (NTLP and TLP) of 20 patients each.
For each participant, the experimental phase of the study will consist of three observation intervals: T0 (verification of the eligibility criteria, patient allocation to treatment; T1 (performed within 3 months from T0 for assessment of clinical parameters, treatment administration, and administration of questionnaires before and after treatment; T2 (performed at 8-12 weeks after T1 for the assessment of clinical parameters).
At T1, following routine periodontal clinical assessment and questionnaire completion, patients will receive test or control treatment according to the randomization list. Test treatment will consist of a single session structured as follows: (i) information on periodontal diagnosis; (ii) information on periodontal risk level (as calculated with the PerioRisk tool) and profile (i.e., the magnitude of the contribution of each PerioRisk parameter to generate the patient risk level); (iii) information on treatment plan and oral hygiene instructions, with emphasis to treatment goals based on the PerioRisk output. Control treatment will consist in a single session structured as follows: (i) information on periodontal diagnosis; (ii) information on treatment plan and oral hygiene instructions, and treatment goals. Although the general concept of risk of periodontitis incidence/progression will be explained, no mention will be made to the patient risk level (as calculated with PerioRisk or any other tool) when administering control treatment. Two operators will be trained to administer test and control treatments in approximately 8', but time for treatment administration will be extended for additional questions and answers whenever needed by the patient. Total time for treatment administration will be recorded.
Patients will be administered the following battery of psychological questionnaires: (i) Positive Affect Negative Affect Scale (PANAS) (Watson et al. 1988); (ii) Protection Motivation Theory (PMT) questionnaire (Conner \& Norman 2005); (iii) Hospital Anxiety and Depression Scale (HADS-A/D) (Zigmond \& Snaith 1983). While HADS-A/D will be used to screen out patients with clinical anxiety/ depression before treatment administration, PANAS and PMT will be completed either immediately before and immediately after treatment administration.
Detailed description
SCIENTIFIC BACKGROUND The standardized application of the same protocols (for intensity, modality, and monitoring) for primary and secondary prevention of periodontitis as well as for the active treatment phase itself will rarely meet the individual's needs, resulting in under-provision of care to some and over-provision to others, with unwanted side effects and suboptimal allocation of resources. To deliver personalized and precision periodontal care, risk assessment should be incorporated in the periodontal evaluation as a third dimension, to comprehensively assess and interpret factors that may have an impact on future disease onset or progression and upon a patient's anticipated response to periodontal treatment. Previous studies showed that patients receiving information on individual periodontal risk level had significantly higher consciousness of disease seriousness and significantly higher intention to adhere to treatment instructions after consultation. These findings support the use of this system in clinical practice and obtain greater patient adherence to the suggested preventive and treatment protocols. Although the periodontal risk assessment method proposed by the University of Ferrara (namely, the PerioRisk) has been retrospectively validated and has been shown as a promising tool for tailoring supportive periodontal care, no information on its efficacy on psychological outcomes is currently available.
AIM Primary aim: to evaluate the efficacy of communicating periodontal risk level (as assessed with the PerioRisk tool) on psychological outcomes (i.e, patient consciousness and propensity to adhere to treatment instructions) in subjects who have been programmed for first periodontal consultation.
Expected result (primary aim): when communicating information on periodontal diagnosis, periodontal treatment plan, oral hygiene instructions and periodontal treatment goals to the patient undergoing first periodontal consultation, the adjunctive use of the PerioRisk tool will result in significantly increased levels of patient consciousness and propensity to adhere to treatment instructions.
Secondary aim #1: to comparatively evaluate the level of consciousness and propensity to adhere to treatment instructions in (i) patients without a history of tooth loss due to periodontitis (as evaluated after communication of their periodontal risk level) and (ii) patients with a history of tooth loss due to periodontitis (as evaluated before their periodontal consultation).
Expected result (secondary aim #1): in subjects without a history of tooth loss due to periodontitis, the adjunctive use of the PerioRisk tool during first periodontal consultation will improve patient consciousness and propensity to adhere to treatment instructions up to levels that are reached with periodontitis-associated tooth loss.
Secondary aim 2: to comparatively evaluate oral hygiene levels in patients who have received information on their diagnosis, treatment plan, oral hygiene instructions and treatment goals with or without the support of PerioRisk during their consultation.
Expected result (secondary aim #2): at a distance of 8-12 weeks from consultation, greater improvements in full-mouth Plaque Index will be observed in patients who have received information on their diagnosis, treatment plan, oral hygiene instructions and treatment goals with the support of the PerioRisk tool.
EXPERIMENTAL DESIGN The study is designed as a multicenter, single-blind, parallel-arm, randomized trial.
MATERIALS \& METHODS Participating clinical centers Participants will be recruited at 2 centers: (i) Section of Dentistry, University of Ferrara; and (ii) Operative Unit of Dentistry, Azienda Unità Sanitaria Locale of Ferrara, Italy.
Study population Specific inclusion and exclusion criteria will be used to recruit adult patients programmed for their first periodontal consultation. Patient selection will ensure a balanced distribution (1:1 ratio) of patients with and without a history of tooth loss due to periodontitis (Tooth Loss due to Periodontitis, TLP group; and No Tooth Loss due to Periodontitis, NTLP group).
Sample size Based on data from the study by Asimakopoulou et al. (2015), a per-protocol study of 62 patients will be sufficient to detect a significant inter-group difference in the primary outcome measure (i.e., patient propensity to adhere to treatment instructions) with a two-sided test at a p-level of 0.05 and a statistical power of 80%. An intention-to-treat population of 80 patients (40 allocated to test treatment, 40 allocated to control treatment) will be used for the study.
Observation intervals
For each participant, the experimental phase of the study will consist of three observation intervals:
T0 (screening visit): verification of the eligibility criteria, patient allocation to treatment; T1 (within 3 months from T0): assessment of clinical parameters; treatment administration; administration of questionnaires before and after treatment; T2 (8-12 weeks after T1): assessment of clinical parameters.
Experimental treatments and patient allocation to treatment Following routine periodontal clinical assessment and questionnaire completion (see study parameters for details), patients will receive test treatment (RISK) or control treatment (TaU) according to the randomization list (as created using a random digit generator). Before the study, two operators (A.S. and M.E.G.) will be trained to administer RISK or TaU in approximately 8 minutes. The patient will be left free to interrupt the session for questions, if needed. Only the operator and the patient will be present in the operating room during treatment administration. Whenever needed by the patient, time for treatment administration will be extended for additional questions and answers. Total time for treatment administration will be recorded.
Statistical methods Non-parametric two-sided statistical tests will be used for intra-group comparisons (i.e., pre- vs post-treatment administration; Wilcoxon paired samples test) and inter-group comparisons (i.e., RISK vs TaU and TLP vs NTLP; Mann-Whitney U-test) for scores obtained from the psychological questionnaires. Cronbach's alpha will be calculated for the PMT scale overall to assess internal consistency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is designed as a multicenter, single-blind, parallel-arm, randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Patients without a history of tooth loss due to periodontitis (NTLP) | Other | Behavioral: Test treatment, Behavioral: Control treatment |
| Patients with a history of tooth loss due to periodontitis (TLP) | Other | Behavioral: Test treatment, Behavioral: Control treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- possessing a recent (i.e., performed within 24 months) bidimensional radiograph (orthopantomography or periapical status) or programmed to perform the radiographic exam;
- speaking Italian fluently.
Key exclusion criteria (5 listed)
- history of a previous periodontal diagnosis;
- conditions (es. psychiatric diseases, alcohol abuse) or drug exposures (e.g., antidepressants) that may influence the results of psychological questionnaires;
- lack of a recent (i.e., performed within 24 months) bidimensional radiograph and not able/willing to provide the exam (e..g., due to pregnancy);
- not presenting at two programmed study visits consecutively;
- pre-treatment HADS score indicative of clinical depression.
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 |
|---|---|---|
| Test treatmentAlso: Periodontal risk assessmentTest treatment will consist of a single session structured as follows: (i) information on periodontal diagnosis (as formulated according to the classification system of the 2017 World Workshop for the Classification of Periodontal Diseases and Conditions); (ii) information on periodontal risk level (as calculated with the PerioRisk tool proposed by Trombelli et al. 2009) and profile (i.e., the magnitude of the contribution of each PerioRisk parameter to generate the patient risk level); (iii) information on treatment plan and oral hygiene instructions, with emphasis to treatment goals based on the PerioRisk output. The operators will be trained to administer test treatment in approximately 8 minutes, but the duration of the session will be extended for additional questions and answers upon patient request. | Behavioural | Patients with a history of tooth loss due to periodontitis (TLP), Patients without a history of tooth loss due to periodontitis (NTLP) |
| Control treatmentAlso: Treatment as usualControl treatment will consist in a single session structured as follows: (i) information on periodontal diagnosis (as formulated according to the classification system of the 2017 World Workshop for the Classification of Periodontal Diseases and Conditions); (ii) information on treatment plan and oral hygiene instructions, and treatment goals. Although the general concept of risk of periodontitis incidence/progression will be explained, no mention will be made to the patient risk level as calculated with PerioRisk or any other tool. The operators will be trained to administer control treatment in approximately 8 minutes, but the duration of the session will be extended for additional questions and answers upon patient request. | Behavioural | Patients with a history of tooth loss due to periodontitis (TLP), Patients without a history of tooth loss due to periodontitis (NTLP) |
Primary outcome
Propensity to adhere to treatment instructions over the next 8-12 weeks
Time frame: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
The outcome consists of the mean post-treatment change in the patient-related score related to the item "Intention" of the Protection Motivation Theory (PMT) questionnaire (Conner \& Norman 2005). The score can range on a scale from 1 to 10, with higher scores indicating a better outcome (i.e., greater propensity to adhere to treatment instructions).
8 secondary outcomes
Mean change in the score related to "Positive emotions"
Time frame: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Negative emotions"
Time frame: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Seriousness"
Time frame: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Susceptibility"
Time frame: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Treatment effectiveness"
Time frame: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Self-efficacy"
Time frame: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Treatment barriers"
Time frame: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
Mean change in the score related to "Fear"
Time frame: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)
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 25 Mar 2025.
- Derived from this study: PubMed 38956317Farina R, Simonelli A, Guarnelli ME, Secchiati G, Montemezzo G, Scapoli C, Trombelli L. Efficacy of communicating periodontal risk on psychological outcomes and supragingival plaque control in patients undergoing first periodontal consultation: A parallel-arm, randomized trial. J Clin Periodontol. 2024 Oct;51(10):1289-1301. doi: 10.1111/jcpe.14032. Epub 2024 Jul 2.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test treatment in people with Periodontitis and Periodontal Diseases, run by Università degli Studi di Ferrara at 2 sites 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 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Propensity to adhere to treatment instructions over the next 8-12 weeks (time frame: up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)). 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 NCT05078411, which also lists 1 linked publication.
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 25 Mar 2025.