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Effect of Stress on Periodontal Therapy (NPT)

Primary Purpose

Stress, Psychological, Periodontal Diseases, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non Surgical Periodontal Therapy
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CIR Dental School

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Non surgical Periodontal Therapy NPT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
Change in Clinical Attachment Level CAL (0 - 15mm with higher values indicating worse outcomes.
The sum of Probing pocket depth (PD) and Recession (Rec)

Full Information

First Posted
January 25, 2021
Last Updated
January 22, 2022
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT04739475
Brief Title
Effect of Stress on Periodontal Therapy (NPT)
Official Title
Association of Stress and Non-surgical Periodontal Therapy (NPT) Outcome in Patients With Periodontitis Stage III/V Grade A/B Generalised
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Periodontal Diseases, Periodontitis, Non Surgical Periodontal Therapy, Inflammation, Bleeding on Probing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non surgical Periodontal Therapy NPT
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non Surgical Periodontal Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Full Mouth Bleeding Score FMBS% (0 - 100 % with higher percentage indicating worse status)
Description
Percentage of full mouth bleeding sites after probing considering 6 sites for each tooth.
Time Frame
Baseline and 6 weeks after the completion of the therapy.
Secondary Outcome Measure Information:
Title
Change in Full Mouth Plaque Score FMPS% (0 - 100 % with higher percentage indicating worse status)
Description
Percentage of full mouth plaque score considering 6 sited for each tooth.
Time Frame
Baseline and 6 weeks after the completion of the therapy.
Title
Change in Probing Pocket Depth PD (0 - 15mm with higher values indicating worse outcomes.
Description
The distance between the cementoenamel junction (CEJ) and the base of the pocket.
Time Frame
Baseline and 6 weeks after the completion of the therapy.
Title
Change in Gingival Recession Rec (0 - 15mm with higher values indicating worse outcomes.
Description
The distance between the cementoenamel junction (CEJ) and the free gingival margin
Time Frame
Baseline and 6 weeks after the completion of the therapy.
Title
Change in Clinical Attachment Level CAL (0 - 15mm with higher values indicating worse outcomes.
Description
The sum of Probing pocket depth (PD) and Recession (Rec)
Time Frame
Baseline and 6 weeks after the completion of the therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CIR Dental School
City
Turin
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Stress on Periodontal Therapy (NPT)

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