Effect of Stress on Periodontal Therapy (NPT)

Inflammation Clinical Trial

Official title:

Association of Stress and Non-surgical Periodontal Therapy (NPT) Outcome in Patients With Periodontitis Stage III/V Grade A/B Generalised

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04739475
• Other study ID #: UTurin01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: January 2022
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of this study:

is to evaluate the influence of stress level on the response of non surgical periodontal therapy in patients affected by severe periodontitis divided into "Medium/High stress level" or "Low stress level" based on the Perceived Stress Scale (PSS). The defined primary outcome referring to the clinical response of the patients is the bleeding index, Full-Mouth Bleeding Score (FMBS), as a clinical sign of inflammation.

Materials and Methods:

Monocentric prospective triple blinded study. A single evaluator conducting all the psychologic tests, a single operator blinded to the results of the psychologic tests doing all the clinical measurements, and the patients will be initially blinded to the category of stress that they'll belong to. The minimum number of patients to enrol will be 89 based on a sample calculation.

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

Age from 20 to 80 years Diagnosis of Periodontitis stage III/IV according to the new classification (2018); Presence of at least 14 teeth, with a minimum of 10 sites with PD at least > 5 mm and radiographic evidence of alveolar bone loss.

Written informed consent

Exclusion Criteria.

The presence of any of the following will exclude a subject from study enrollment:

Smokers > 10 cig/die Patients with orthodontic appliances; Pregnant or lactating women; Individuals who have received periodontal treatment in the 6 months prior to recruitment; Patients with systemic diseases that could interfere the clinical response to periodontal treatment (i.e. diabetes); Subjects under treatment with antibiotics, steroidal and/or non-steroidal anti-inflammatory medication 3 weeks prior to the visit and patients treated with antiepileptic drugs

Operative procedure:

Clinical parameters and psychologic test will be done at the baseline. All the patients will be treated by means of non surgical periodontal therapy on a quadrant protocol including oral hygiene instructions and motivations and subgingival instrumentation in four successive visits. 6 weeks after the last visit, the clinical parameters will be registered again.

Clinical Parameters:

Periodontal condition of each patient will be evaluated through the collection of the following parameters:

• Full-Mouth Bleeding score (FMBS): presence/absence of bleeding on probing using a periodontal probe on each surface of the tooth (six sites per tooth), calculated in percentage for all the examined teeth.

• Full-Mouth Plaque Score (FMPS): presence/absence of plaque using a periodontal probe on each surface of the tooth (six sites per tooth), calculated in percentage for all the examined teeth.

• Probing Depth (PD): measured for each surface of the tooth (six sites per tooth) using a periodontal probe, measured as the distance between the cementoenamel junction (CEJ) and the depth of the pocket.

• Gingival recession (Rec): measured for each surface of the tooth (six sites per tooth) using a periodontal probe, measured as the distance between the cementoenamel junction (CEJ) and the free gingival margin.

• Clinical attachment level (CAL): The sum of PD and Rec.

Psychologic Test:

The Stress condition of each patient will be assessed by a Psychologist using:

PSS is a 10-items self-report questionnaire that measure the degree to which situations in one's life are appraised as stressful. The PSS is scored on a 5-point scale (never, almost never, sometimes, fairly often and very often). PSS norms are available from a sample of the USA collected by Cohen & Williamson (1988). The mean level for men was 12.1 (S.D. 5.9) and for women 13.7 (S.D. 6.6).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 20, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Periodontitis stage III/IV according to the new classification (2018);

• Presence of at least 14 teeth, with a minimum of 10 sites with PD at least > 5 mm and radiographic evidence of alveolar bone loss.

• Written informed consent

Exclusion Criteria:

• Smokers > 10 cig/die

• Patients with orthodontic appliances;

• Pregnant or lactating women;

• Individuals who have received periodontal treatment in the 6 months prior to recruitment;

• Patients with systemic diseases that could interfere the clinical response to periodontal treatment (i.e. diabetes);

• Subjects under treatment with antibiotics, steroidal and/or non-steroidal anti-inflammatory medication 3 weeks prior to the visit and patients treated with antiepileptic drugs.

Related Conditions & MeSH terms

• Bleeding on Probing
• Inflammation
• Non Surgical Periodontal Therapy
• Periodontal Diseases
• Periodontitis
• Stress, Psychological

Intervention

Procedure:
• Non Surgical Periodontal Therapy
Conventional staging debridement (CSD) according to the severity of periodontal disease in 2 to 4 appointments at day 0, 7, 14 and 21. Supra and subgingival scaling and polishing will be performed by the use of manual and ultrasonic instruments and oral hygiene instructions will be given. Patients will be instructed to use interdental brushes with appropriate size interdental brushes or dental floss when interdental embrasures will not allow for interdental brushing.

Locations

Country	Name	City	State
Italy	CIR Dental School	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Full Mouth Bleeding Score FMBS% (0 - 100 % with higher percentage indicating worse status)	Percentage of full mouth bleeding sites after probing considering 6 sites for each tooth.	Baseline and 6 weeks after the completion of the therapy.
Secondary	Change in Full Mouth Plaque Score FMPS% (0 - 100 % with higher percentage indicating worse status)	Percentage of full mouth plaque score considering 6 sited for each tooth.	Baseline and 6 weeks after the completion of the therapy.
Secondary	Change in Probing Pocket Depth PD (0 - 15mm with higher values indicating worse outcomes.	The distance between the cementoenamel junction (CEJ) and the base of the pocket.	Baseline and 6 weeks after the completion of the therapy.
Secondary	Change in Gingival Recession Rec (0 - 15mm with higher values indicating worse outcomes.	The distance between the cementoenamel junction (CEJ) and the free gingival margin	Baseline and 6 weeks after the completion of the therapy.
Secondary	Change in Clinical Attachment Level CAL (0 - 15mm with higher values indicating worse outcomes.	The sum of Probing pocket depth (PD) and Recession (Rec)	Baseline and 6 weeks after the completion of the therapy.