NCT04739475

Effect of Stress on Periodontal Therapy (NPT)

Completed NA Last updated 25 January 2022

What this trial tests

NA trial testing Non Surgical Periodontal Therapy in Stress, Psychological in 89 participants. Completed in 20 December 2021.

Timeline

1 March 2021

Primary endpoint
15 June 2021

20 December 2021

Quick facts

Lead sponsor	University of Turin, Italy
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	89
Start date	1 March 2021
Primary completion	15 June 2021
Estimated completion	20 December 2021
Sites	1 location across Italy

Drugs / interventions tested

• Non Surgical Periodontal Therapy

Conditions studied

• Stress, Psychological — all drugs for Stress, Psychological →
• Periodontal Diseases — all drugs for Periodontal Diseases →
• Periodontitis — all drugs for Periodontitis →
• Non Surgical Periodontal Therapy — all drugs for Non Surgical Periodontal Therapy →

Sponsor

University of Turin, Italy

Who can join

Adults 20 to 80, any sex, with Stress, Psychological or Periodontal Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of psychosocial stress and coping strategies on non-surgical periodontal therapy in patients with generalized stage III/IV periodontitis: a longitudinal intervention study.
   Romano F, Bebars A, Ortu V, Bottone M, et al · · 2023 · cited 4× · PMID 36961591 · DOI 10.1007/s00784-023-04956-w