Predictors of Periodontal Outcomes Post-sanative Therapy
15 novembre 2021 mis à jour par: Wendy E. Ward, Ph.D., Brock University
Predictors of Periodontal Outcomes in Patients 5 to 10 Years Post-sanative Therapy
Periodontal disease is a chronic inflammatory disease of the tissues surrounding the teeth and is one of the leading causes of tooth loss.
Sanative therapy (ST) is a non-surgical procedure that allows for removal of bacteria from the deep pockets that form around teeth and is the frontline treatment for periodontal disease.
Post-ST, patients require ongoing maintenance appointments to maintain their oral health, though whether risk factors for periodontal disease remain a predictor of periodontal health post-ST has not been comprehensively investigated.
Risk factors to be examined include physical activity, exercise, sedentary time, flavonoid intake, protein intake, BMI, sex, age, smoking status, and number of sites with periodontal probing depth (PPD) ≥ 4mm at baseline.
Aperçu de l'étude
Statut
Résilié
Les conditions
Description détaillée
Periodontal disease is a main cause of tooth loss.
Patients with periodontal disease may receive sanative therapy (ST), a deep cleaning of the teeth that helps prevent the progression of periodontal disease.
Post-ST, maintenance appointments are an important part of the strategy used to help these patients prevent the progression of periodontal disease and maintain their periodontal health.
Given that numerous chronic diseases, obesity, low levels of physical activity, being a smoker, poor diet, and older age are all risk factors for periodontal disease, these factors may also be predictive of worse periodontal health 5 to 10 years post-ST.
Many modifiable periodontal risk factors such a physical activity, exercise, and obesity have not been studied in relation to periodontal outcomes post-ST, and other factors such as diet, sex and age have not been comprehensively studied.
The primary objective of this study is to determine, at 5 to 10 years post-ST, if physical activity, exercise, sedentary time, flavonoid intake, protein intake, BMI, sex, age, smoking status, and number of sites with periodontal probing depth (PPD) ≥ 4 mm at baseline are significant predictors of periodontal health.
A secondary objective is to determine if lifetime estrogen exposure impacts periodontal health in women.
Periodontal health will be measured using probing depth, tooth loss, bleeding on probing and plaque index.
Established questionnaires will be used to assess dietary intake, physical activity and sedentary behaviour.
Within the study the investigators will also assess if and how a patient's periodontal health has been impacted by clinic closures and rescheduling of maintenance appointments that were mandated by regulatory organizations as a result of the COVID-19 pandemic.
The investigators will also ask questions about changes in diet, physical activity and oral hygiene during COVID-19.
Type d'étude
Observationnel
Inscription (Réel)
12
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ontario
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Fonthill, Ontario, Canada, L0S1E5
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
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St. Catharines, Ontario, Canada, L2S3A1
- Brock University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
19 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Adult patients who underwent sanative therapy to manage periodontal disease at this clinic 5 to 10 years before present-day appointment.
Only patients who have maintained regular maintenance appointments after receiving sanative therapy will be eligible.
La description
Inclusion Criteria:
- Have undergone sanative therapy (ST) in the past 5 to 10 years
- Age > 19 years
- Willingness and ability to provide informed consent. Participants must be able and willing to complete online questionnaires from home and give permission for access to their periodontal records from the time of their sanative therapy to present day
Exclusion Criteria:
- Individuals with physical or mental limitations that inhibit them from conducting their own personal oral hygiene (oral hygiene is a key component in maintaining periodontal health)
- Women who are currently pregnant or breastfeeding (hormonal changes during pregnancy are known to cause gingival inflammation)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Probing depth
Délai: At maintenance appointment (present day)
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This is a routine clinical measure of periodontal health (measured in mm)
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At maintenance appointment (present day)
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Probing depth
Délai: Pre-sanative therapy
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This is a routine clinical measure of periodontal health (measured in mm)
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Pre-sanative therapy
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Probing depth
Délai: 8-12 weeks post-sanative therapy
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This is a routine clinical measure of periodontal health (measured in mm)
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8-12 weeks post-sanative therapy
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Bleeding on probing
Délai: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth
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At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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Bleeding on probing
Délai: Pre-sanative therapy
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This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth
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Pre-sanative therapy
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Bleeding on probing
Délai: 8-12 weeks post-sanative therapy
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This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth
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8-12 weeks post-sanative therapy
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tooth Loss
Délai: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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Will be measured as the number of teeth lost due to periodontal disease
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At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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Tooth Loss
Délai: Pre-sanative therapy
|
Will be measured as the number of teeth lost due to periodontal disease
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Pre-sanative therapy
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Tooth Loss
Délai: 8-12 weeks post-sanative therapy
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Will be measured as the number of teeth lost due to periodontal disease
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8-12 weeks post-sanative therapy
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O'Leary Index of Plaque Control
Délai: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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The patient's plaque index= the number of plaque-containing surfaces divided by the total number of available surfaces.
The minimum plaque index would be 0% which represents no tooth surfaces that contain plaque/ The maximum plaque index would be 100%, which represents all surfaces of the patient's teeth containing plaque.
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At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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Indice O'Leary de contrôle de la plaque
Délai: Thérapie présanative
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L'indice de plaque du patient = le nombre de surfaces contenant de la plaque divisé par le nombre total de surfaces disponibles.
L'indice de plaque minimum serait de 0 %, ce qui représente l'absence de surfaces dentaires contenant de la plaque. L'indice de plaque maximum serait de 100 %, ce qui représente toutes les surfaces des dents du patient contenant de la plaque.
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Thérapie présanative
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Indice O'Leary de contrôle de la plaque
Délai: 8 à 12 semaines de traitement post-sanatif
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L'indice de plaque du patient = le nombre de surfaces contenant de la plaque divisé par le nombre total de surfaces disponibles.
L'indice de plaque minimum serait de 0 %, ce qui représente l'absence de surfaces dentaires contenant de la plaque. L'indice de plaque maximum serait de 100 %, ce qui représente toutes les surfaces des dents du patient contenant de la plaque.
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8 à 12 semaines de traitement post-sanatif
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body Mass Index (BMI)
Délai: Patients will complete this in an online questionnaire at present day (baseline).
|
Patients will self-report their height and weight in an online questionnaire.
This information will be used to calculate BMI which is a known risk factor of periodontal disease.
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Patients will complete this in an online questionnaire at present day (baseline).
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Godin Leisure Time Exercise Questionnaire
Délai: Patients will complete this in an online questionnaire at present day (baseline).
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This questionnaire measures, at one time point, self-reported exercise habits for the past 7 days. This questionnaire includes 4 items and has been combined with the International Physical Activity Questionnaire. Name of score: Weekly leisure activity score; Minimum score: 0 units and Maximum score: 24 units or more and defined as "active". A higher score indicates a better outcome. |
Patients will complete this in an online questionnaire at present day (baseline).
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International Physical Activity Questionnaire (IPAQ)
Délai: Patients will complete this online questionnaire at present day (baseline).
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This questionnaire measures, at one time point, self-reported physical activity and sedentary behavior habits. It contains 27 items and has been combined with the Godin Leisure Time Exercise Questionnaire and modified version of the indices of estrogen exposure questionnaire in an online format. They will self-report their physical activity and sedentary behavior for the past 7 days. Name of score: Weekly physical activity score; Minimum score: 1 and defined as "low physical activity" and Maximumscore: 3 and defined as "high physical activity". A higher score indicates a better outcome. |
Patients will complete this online questionnaire at present day (baseline).
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Flavonoid and protein intake
Délai: Patients will report their dietary intake at present day (baseline) for the past 24 hours. This will be done three times for three separate dates.
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Flavonoid and protein intake will be measured with the automated self-administered dietary intake (ASA-24) questionnaire.
This is an online food recall that patients will complete three times, reporting on their dietary intake from the last 24 hours.
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Patients will report their dietary intake at present day (baseline) for the past 24 hours. This will be done three times for three separate dates.
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Lifetime estrogen exposure (LEE)
Délai: Patients will complete this online questionnaire at present day (baseline).
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The indices of estrogen exposure questionnaire will be used to determine LEE using the estimated lifetime estrogen exposure (ELEE) model.
The ELEE reflects the reproductive span, comprising a woman's time between age at menarche and age at menopause (or age at recruitment minus age at menarche for pre-menopausal women) minus 1 year for each pregnancy and duration of breastfeeding, calculated at the time at recruitment.
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Patients will complete this online questionnaire at present day (baseline).
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Dietary supplement and tea intake
Délai: Patients will complete this questionnaire online prior to their maintenance appointment
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Intakes of specific dietary supplements and tea will be measured using a dietary supplement and tea intake questionnaire.
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Patients will complete this questionnaire online prior to their maintenance appointment
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COVID-19 Interview questions
Délai: Patients will complete these interview questions during their one-on-one virtual meeting with a member of the research team at present day (baseline).
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Patients will be asked interview questions about changes to their dietary intake, physical activity and oral hygiene habits resulting from the COVID-19 pandemic
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Patients will complete these interview questions during their one-on-one virtual meeting with a member of the research team at present day (baseline).
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Wendy E Ward, PhD, Brock University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
25 novembre 2020
Achèvement primaire (Réel)
20 octobre 2021
Achèvement de l'étude (Réel)
20 octobre 2021
Dates d'inscription aux études
Première soumission
9 novembre 2020
Première soumission répondant aux critères de contrôle qualité
17 novembre 2020
Première publication (Réel)
20 novembre 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 novembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 novembre 2021
Dernière vérification
1 novembre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20-070
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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Étudie un produit d'appareil réglementé par la FDA américaine
Non
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