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

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

Interventions

BEHAVIORAL

Test treatment

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.

BEHAVIORAL

Control treatment

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.

Sponsors & Collaborators

• Università degli Studi di Ferrara

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2023-07-31

Completion

2023-12-31

Countries

• Italy

Study Locations