Influence of Environmental Factors on the Efficacy of Non-surgical Periodontal Treatment. A Pre-post Quasi-experimental Study

Periodontitis Clinical Trial

Official title:

Influence of Environmental Factors on the Efficacy of Non-surgical Periodontal Treatment. A Pre-post Quasi-experimental Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04769622
• Other study ID #: NST001
• Status: Recruiting
• Start date: February 16, 2021
• Est. completion date: November 25, 2021

Study information

• Verified date: February 2021
• Source: University of Siena
• Contact: Nicola Discepoli, DDS, MsC, PhD
• Phone: 0577585772
• Email: nicola.discepoli2[@]unisi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Periodontitis is a biofilm-mediated chronic inflammatory disease which causes the destruction of the supporting tissues of the tooth. Risk factors for periodontitis include familiarity for periodontal diseases, diabetes, cardiovascular diseases, metabolic syndrome, obesity and stress. Some studies demonstrated how these risk factors negatively influence the patients' response to non-surgical periodontal treatment. The success of non-surgical periodontal therapy is defined through the treat-to-target concept (i.e. a maximum of 4 sites with Probing Pocket Depth >5mm and presence of Bleeding on Probing); therefore, periodontal treatment is successful whenever this threshold is reached. Moreover, given the available data regarding the association between more severe forms of periodontitis and a lower frequency of physical activity, a worse sleep quality and more perceived stress, it is reasonable to hypothesize that these factors could influence the patients' response to non-surgical periodontal treatment. With regards to diet, despite many studies appraised the anti-inflammatory effect of the mediterranean diet, no study has ever related adherence to Mediterranean Diet to oral health status. The novelty that the present study would introduce is the evaluation of how environmental factors (i.e. diet, physical exercise, perceived stress) influence patients' response to non-surgical periodontal therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: November 25, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age between 18 and 70 years old;
• presence of untreated periodontitis (Papapanou at al. 2018);
• ability and willingness to give informed consent.

Exclusion Criteria:

• pregnancy or lactation;
• patients who underwent non-surgical periodontal therapy in the last 6 months;
• patients taking immunosuppressive drugs;
• inability or unwillingness to give informed consent.

Related Conditions & MeSH terms

• Non Surgical Periodontal Treatment
• Periodontal Diseases
• Periodontitis

Intervention

Procedure:
• Non-surgical periodontal treatment
all included patients will be subjected to non-surgical periodontal therapy

Other:
• Questionnaires
All patients will be asked to complete a set of questionnaires regarding: adherence to Mediterranean Diet; sleep quality; physical activity; perceived stress.

Locations

Country	Name	City	State
Italy	AOUS	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treat-to-target after treatment (yes/no)	Binary outcome defining the success of non-surgical periodontal treatment. The treat-to-target is reached whenever patients at reevaluation have a maximum of 4 sites with Probing Pocket Depth (PPD) >5mm and presence of Bleeding on Probing (BoP)	outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Secondary	Influence of adherence to Mediterranean diet on the success of non-surgical periodontal treatment (treat-to-target)	results obtained from the questionnaire about adherence to Mediterranean Diet (Gnagnarella et al. 2018) will be placed in a logistic regression model, whose aim will be to investigate the influence of adherence to Mediterranean diet (predictors) on the success of non surgical periodontal treatment (treat to target; dependent variable). Adherence to Mediterranean diet is evaluated on a scale between 0 and 9; the higher the score, the higher the adherence to Mediterranean Diet.	outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Secondary	Influence of Sleep Quality on the success of non-surgical periodontal treatment (treat-to-target)	results obtained from the questionnaire about Sleep Quality (Pittsburgh Sleep Quality Index) will be placed in a logistic regression model, whose aim will be to investigate the influence of sleep quality (predictor) on the success of non surgical periodontal treatment (treat to target; dependent variable). Sleep quality is evaluated on a scale between 0 and 21; the higher the score, the poorer the Sleep Quality.	outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Secondary	Influence of Physical Activity on the success of non-surgical periodontal treatment (treat-to-target)	results obtained from the questionnaire about Physical Activity (International Physical Activity Questionnaire) will be placed in a logistic regression model, whose aim will be to investigate the influence of amount of Physical activity (predictor) on the success of non surgical periodontal treatment (treat to target; dependent variable). Physical activity is evaluated on a scale between 0 and 2 (0= low physical activity; 1= moderate physical activity; 2= intense physical activity).	outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Secondary	Influence of Perceived Stress on the success of non-surgical periodontal treatment (treat-to-target)	results obtained from the questionnaire about Perceived stress (Italian Perceived Stress Scale) will be placed in a logistic regression model, whose aim will be to investigate the influence of perceived stress (predictor) on the success of non surgical periodontal treatment (treat to target; dependent variable). Perceived Stress is evaluated on a scale between 0 and 40; the higher the score, the higher the stress perceived.	outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)