Efficacy of Periodontal Risk Communication in Patients With and Without History of Tooth Loss

NCT05078411 | Completed

• 1 other identifier: PERIORISK
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Periodontitis; Periodontal Diseases; Communication

Keywords

periodontitis; periodontal diseases; prognosis; risk assessment; risk factor; communication; consciousness; propensity

Outcome Measures

Primary Outcomes (1)

• 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).

  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"

  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"

  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"

  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"

  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"

  up to 3 months following the screening visit (i.e., at T1, both before and after treatment administration)

Study Arms (2)

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

Interventions

Test treatment BEHAVIORAL

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.

Also known as: Periodontal risk assessment

Patients with a history of tooth loss due to periodontitis (TLP); Patients without a history of tooth loss due to periodontitis (NTLP)

Control treatment BEHAVIORAL

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.

Also known as: Treatment as usual

Patients with a history of tooth loss due to periodontitis (TLP); Patients without a history of tooth loss due to periodontitis (NTLP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (2)

Operative Unit of Dentistry, Azienda Unità Sanitaria Locale (AUSL)

Ferrara, 44121, Italy

Location

Section of Dentistry, University of Ferrara

Ferrara, 44121, Italy

Location

Related Publications (1)

• 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.

  PMID: 38956317 DERIVED

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Communication

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The examiner responsible for administrating psychological questionnaires will be kept blinded as to patient allocation to treatment (the examiner will leave the operating room when treatment allocation is disclosed and when the operator delivers the assigned treatment).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor and Chair of Periodontology

Model Details: The study is designed as a multicenter, single-blind, parallel-arm, randomized trial.

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 14, 2021
• Study Start: December 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

IT (2)