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Stress, PsychologicalNCT04739475

Effect of Stress on Periodontal Therapy (NPT)

A study testing Non Surgical Periodontal Therapy in people with Stress, Psychological and Periodontal Diseases, run by University of Turin, Italy at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Non Surgical Periodontal Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteItaly
Study dates
1 Mar 2021to 20 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • CIR Dental School

    Turin, 10126

Other trials in Italy

About this study

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

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.

Read more

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).

Being tested
Non Surgical Periodontal Therapy
Medical subject headings
Stress, Psychological, Periodontal Diseases, Periodontitis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non Surgical Periodontal TherapyProcedure or surgery

    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.

Study groups in NCT04739475
Study groupRoleWhat they receive
Non surgical Periodontal Therapy NPTOtherConventional 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.
Receives: Procedure: Non Surgical Periodontal Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 6 weeks after the completion of the therapy.

Secondary outcomes (4)
  1. 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.

    Measured: Baseline and 6 weeks after the completion of the therapy.

  2. 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.

    Measured: Baseline and 6 weeks after the completion of the therapy.

  3. 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

    Measured: Baseline and 6 weeks after the completion of the therapy.

  4. Change in Clinical Attachment Level CAL (0 - 15mm with higher values indicating worse outcomes.

    The sum of Probing pocket depth (PD) and Recession (Rec)

    Measured: Baseline and 6 weeks after the completion of the therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start1 Mar 2021
  3. Primary completion15 Jun 2021
  4. Study completion20 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739475
Sponsor's protocol ID
UTurin01
Status last verified
Jan 2022
First submitted
25 Jan 2021
Last updated
25 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Estrade L, Delpierre A, Rimbaud V, Denis F, Rochefort GY, Renaud M. High-frequency intraoral ultrasonography for periodontal tissue characterization: a pilot study exploring echogenic signatures and inflammation detection. BMC Oral Health. 2025 Dec 11;26(1):97. doi: 10.1186/s12903-025-07485-y.

    PubMed 41372763
  • Romano F, Bebars A, Ortu V, Bottone M, Giraudi M, Mariani GM, Baima G, Aimetti M. Effect of psychosocial stress and coping strategies on non-surgical periodontal therapy in patients with generalized stage III/IV periodontitis: a longitudinal intervention study. Clin Oral Investig. 2023 Jul;27(7):3479-3487. doi: 10.1007/s00784-023-04956-w. Epub 2023 Mar 24.

    PubMed 36961591

Questions about this trial

What is this clinical trial studying?

A study testing Non Surgical Periodontal Therapy in people with Stress, Psychological and Periodontal Diseases, run by University of Turin, Italy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Full Mouth Bleeding Score FMBS% (0 - 100 % with higher percentage indicating worse status) (time frame: Baseline and 6 weeks after the completion of the therapy.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04739475, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.

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