Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

The objective of this single-center prospective study is to evaluate the impact of periodontal treatment on masticatory performance in patients with periodontitis.

Participants will be asked to complete several questionnaires related to their oral health and quality of life. Functional masticatory tests and salivary flow measurements will also be performed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients treated at the university hospital and diagnosed with periodontitis

Adult patients who have provided informed consent

Patients enrolled in a social security system

Patients who speak and understand French.

Disqualifiers

Minors

Pregnant or breastfeeding patients

Patients under legal protection or conservatorship

Patients who refuse to participate in the study

Trial design

Design model

Single group

Treatments tested in this trial

  • Functionnal test

    Other intervention

    Administration of questionnaires, functional masticatory test, and saliva collection.

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: PeriodontisisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The patient's masticatory performance score

The patient's masticatory performance score, obtained from the masticatory performance test (two-color chewing gum test) (quantitative variable).

Time frame
Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)

Secondary outcomes

1

Severity of periodontal disease assessed by stage.

Periodontitis is defined according to two criteria: grade and stage. The latter is used to characterize the severity of periodontal involvement. The stage of periodontitis is determined according to a four-level classification system, ranging from Stage 1 (low) to Stage 4 (high).

Time frame
Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
2

Salivation

Salivary flow is measured by collecting saliva at rest and after stimulation in mL/min. Stimulated salivary flow is assessed after chewing paraffin for 1 minute. The XI questionnaire (Xerostomia Inventory), proposed by Thomson et al. and validated in French, will also be administered (6,7). The XI consists of 11 items. Each item is scored on a scale of 1 to 5 to indicate how frequently the described situation occurs for the patient. The scores for each item are added together to yield a total score ranging from 11 (no dry mouth) to 55 (extreme dry mouth).

Time frame
Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
3

Swallowing

Oropharyngeal dysphagia is assessed using the EAT-10 (Eating Assessment Tool) questionnaire, which has been validated in French. The questionnaire comprises 10 items designed to assess swallowing disorders and the patient's perception of oropharyngeal dysphagia. Each item is rated on a 5-point scale ranging from 0 (no difficulty) to 4 (severe difficulty), resulting in a total score ranging from 0 to 40. A total score of 3 or higher indicates difficulty swallowing safely.

Time frame
Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
4

Periodontitis grade (Chicago Classification)

Grade of periodontitis according to the Chicago Classification. Categorical (Grade A (low) to C (fast) or as defined by classification)

Time frame
Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)

Other outcomes

Sponsors and contacts

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