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.
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
- Conditions the study is for
- Stress, Psychological, Periodontal Diseases, Periodontitis
- What is being tested?
- Non Surgical Periodontal Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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.
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).
- Conditions
- Stress, Psychological, Periodontal Diseases, Periodontitis, Non Surgical Periodontal Therapy, Inflammation, Bleeding on Probing
- 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 group | Role | What they receive |
|---|---|---|
| Non surgical Periodontal Therapy NPT | Other | 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. Receives: Procedure: Non Surgical Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
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.
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.
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.
- First posted4 Feb 2021
- Study start1 Mar 2021
- Primary completion15 Jun 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Baima, University of Turin, Italy
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 41372763Romano 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Stress and Non-surgical Periodontal Therapy (NPT) Outcome in Patients With Periodontitis Stage III/V Grade A/B Generalised
- ClinicalTrials.gov ID
- NCT04739475
- Acronym / sponsor ID
- UTurin01
- Conditions
- Stress, Psychological, Periodontal Diseases, Periodontitis, Non Surgical Periodontal Therapy, Inflammation, Bleeding on Probing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non surgical Periodontal Therapy NPT | Other | Procedure: Non Surgical Periodontal TherapyConventional 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Surgical Periodontal TherapyConventional 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. | Procedure or surgery | Non surgical Periodontal Therapy NPT |
Primary outcome
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.
Percentage of full mouth bleeding sites after probing considering 6 sites for each tooth.
4 secondary outcomes
Change in Full Mouth Plaque Score FMPS% (0 - 100 % with higher percentage indicating worse status)
Time frame: Baseline and 6 weeks after the completion of the therapy.
Change in Probing Pocket Depth PD (0 - 15mm with higher values indicating worse outcomes.
Time frame: Baseline and 6 weeks after the completion of the therapy.
Change in Gingival Recession Rec (0 - 15mm with higher values indicating worse outcomes.
Time frame: Baseline and 6 weeks after the completion of the therapy.
Change in Clinical Attachment Level CAL (0 - 15mm with higher values indicating worse outcomes.
Time frame: Baseline and 6 weeks after the completion of the therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Derived from this study: PubMed 41372763Estrade 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.
- Derived from this study: PubMed 36961591Romano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.