Non Surgical Periodontal TreatmentNCT04769622
Influence of Environmental Factors on the Efficacy of Non-surgical Periodontal Treatment. A Pre-post Quasi-experimental Study
An observational study of Non Surgical Periodontal Treatment and Periodontitis, run by University of Siena at 1 site in Italy.
Trial summary
Periodontitis is a biofilm-mediated chronic inflammatory disease which causes the destruction of the supporting tissues of the tooth. Risk factors for periodontitis include familiarity for periodontal diseases, diabetes, cardiovascular diseases, metabolic syndrome, obesity and stress. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Surgical Periodontal Treatment, Periodontitis, Periodontal Diseases
- What is being tested?
- Non-surgical periodontal treatment and Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- 16 Feb 2021to 25 Nov 2021
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with untreated periodontitis coming to the Unit of Periodontics at the University of Siena and meeting the inclusion and exclusion criteria
Who may be able to join
- age between 18 and 70 years old;
- presence of untreated periodontitis (Papapanou at al. 2018);
- ability and willingness to give informed consent.
Who cannot join
- pregnancy or lactation;
- patients who underwent non-surgical periodontal therapy in the last 6 months;
- patients taking immunosuppressive drugs;
- inability or unwillingness to give informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUS
Siena, 53100
Nicola Discepoli, ndiscepoli@me.com
About this study
Periodontitis is a biofilm-mediated chronic inflammatory disease which causes the destruction of the supporting tissues of the tooth. Risk factors for periodontitis include familiarity for periodontal diseases, diabetes, cardiovascular diseases, metabolic syndrome, obesity and stress. Some studies demonstrated how these risk factors negatively influence the patients' response to non-surgical periodontal treatment. The success of non-surgical periodontal therapy is defined through the treat-to-target concept (i.e. a maximum of 4 sites with Probing Pocket Depth >5mm and presence of Bleeding on Probing); therefore, periodontal treatment is successful whenever this threshold is reached. Moreover, given the available data regarding the association between more severe forms of periodontitis and a lower frequency of physical activity, a worse sleep quality and more perceived stress, it is reasonable to hypothesize that these factors could influence the patients' response to non-surgical periodontal treatment. With regards to diet, despite many studies appraised the anti-inflammatory effect of the mediterranean diet, no study has ever related adherence to Mediterranean Diet to oral health status. The novelty that the present study would introduce is the evaluation of how environmental factors (i.e. diet, physical exercise, perceived stress) influence patients' response to non-surgical periodontal therapy.
- Being tested
- Non-surgical periodontal treatment, Questionnaires
- Keywords
- periodontitis, non surgical periodontal treatment
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
all included patients will be subjected to non-surgical periodontal therapy
QuestionnairesOther
All patients will be asked to complete a set of questionnaires regarding:
- adherence to Mediterranean Diet;
- sleep quality;
- physical activity;
- perceived stress.
| Study group | Role | What they receive |
|---|---|---|
| patients affected by untreated Periodontitis | patients coming to the Unit of Periodontics at the University of Siena will be screened for the inclusion in the study. All patients eligible for the inclusion in the study will undergo non-surgical periodontal treatment and will be administered a questionnaire about lifestyles (adherence to mediterranean diet, sleep quality, physical activity, perceived stress). Patients will be then reevaluated at 3 months after the completion on non-surgical periodontal therapy. Receives: Procedure: Non-surgical periodontal treatment; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treat-to-target after treatment (yes/no)
Binary outcome defining the success of non-surgical periodontal treatment. The treat-to-target is reached whenever patients at reevaluation have a maximum of 4 sites with Probing Pocket Depth (PPD) >5mm and presence of Bleeding on Probing (BoP)
Measured: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Secondary outcomes (4)
Influence of adherence to Mediterranean diet on the success of non-surgical periodontal treatment (treat-to-target)
results obtained from the questionnaire about adherence to Mediterranean Diet (Gnagnarella et al. 2018) will be placed in a logistic regression model, whose aim will be to investigate the influence of adherence to Mediterranean diet (predictors) on the success of non surgical periodontal treatment (treat to target; dependent variable). Adherence to Mediterranean diet is evaluated on a scale between 0 and 9; the higher the score, the higher the adherence to Mediterranean Diet.
Measured: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Influence of Sleep Quality on the success of non-surgical periodontal treatment (treat-to-target)
results obtained from the questionnaire about Sleep Quality (Pittsburgh Sleep Quality Index) will be placed in a logistic regression model, whose aim will be to investigate the influence of sleep quality (predictor) on the success of non surgical periodontal treatment (treat to target; dependent variable). Sleep quality is evaluated on a scale between 0 and 21; the higher the score, the poorer the Sleep Quality.
Measured: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Influence of Physical Activity on the success of non-surgical periodontal treatment (treat-to-target)
results obtained from the questionnaire about Physical Activity (International Physical Activity Questionnaire) will be placed in a logistic regression model, whose aim will be to investigate the influence of amount of Physical activity (predictor) on the success of non surgical periodontal treatment (treat to target; dependent variable). Physical activity is evaluated on a scale between 0 and 2 (0= low physical activity; 1= moderate physical activity; 2= intense physical activity).
Measured: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Influence of Perceived Stress on the success of non-surgical periodontal treatment (treat-to-target)
results obtained from the questionnaire about Perceived stress (Italian Perceived Stress Scale) will be placed in a logistic regression model, whose aim will be to investigate the influence of perceived stress (predictor) on the success of non surgical periodontal treatment (treat to target; dependent variable). Perceived Stress is evaluated on a scale between 0 and 40; the higher the score, the higher the stress perceived.
Measured: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start16 Feb 2021
- Primary completion20 Aug 2021 (estimated)
- Study completion25 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Surgical Periodontal TreatmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769622
- Sponsor's protocol ID
- NST001
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Environmental Factors on the Efficacy of Non-surgical Periodontal Treatment. A Pre-post Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT04769622
- Acronym / sponsor ID
- NST001
- Keywords
- periodontitis, non surgical periodontal treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 20 Aug 2021 (estimated)
- Study completion
- 25 Nov 2021 (estimated)
- First posted
- 24 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.
Periodontitis is a biofilm-mediated chronic inflammatory disease which causes the destruction of the supporting tissues of the tooth. Risk factors for periodontitis include familiarity for periodontal diseases, diabetes, cardiovascular diseases, metabolic syndrome, obesity and stress. Some studies demonstrated how these risk factors negatively influence the patients' response to non-surgical periodontal treatment. The success of non-surgical periodontal therapy is defined through the treat-to-target concept (i.e. a maximum of 4 sites with Probing Pocket Depth >5mm and presence of Bleeding on Probing); therefore, periodontal treatment is successful whenever this threshold is reached. Moreover, given the available data regarding the association between more severe forms of periodontitis and a lower frequency of physical activity, a worse sleep quality and more perceived stress, it is reasonable to hypothesize that these factors could influence the patients' response to non-surgical periodontal treatment. With regards to diet, despite many studies appraised the anti-inflammatory effect of the mediterranean diet, no study has ever related adherence to Mediterranean Diet to oral health status. The novelty that the present study would introduce is the evaluation of how environmental factors (i.e. diet, physical exercise, perceived stress) influence patients' response to non-surgical periodontal therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients affected by untreated Periodontitis | – | Procedure: Non-surgical periodontal treatment, Other: Questionnairespatients coming to the Unit of Periodontics at the University of Siena will be screened for the inclusion in the study. All patients eligible for the inclusion in the study will undergo non-surgical periodontal treatment and will be administered a questionnaire about lifestyles (adherence to mediterranean diet, sleep quality, physical activity, perceived stress). Patients will be then reevaluated at 3 months after the completion on non-surgical periodontal therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with untreated periodontitis coming to the Unit of Periodontics at the University of Siena and meeting the inclusion and exclusion criteria
Key inclusion criteria (3 listed)
- age between 18 and 70 years old;
- presence of untreated periodontitis (Papapanou at al. 2018);
- ability and willingness to give informed consent.
Key exclusion criteria (4 listed)
- pregnancy or lactation;
- patients who underwent non-surgical periodontal therapy in the last 6 months;
- patients taking immunosuppressive drugs;
- inability or unwillingness to give informed consent.
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 treatmentall included patients will be subjected to non-surgical periodontal therapy | Procedure or surgery | patients affected by untreated Periodontitis |
| QuestionnairesAll patients will be asked to complete a set of questionnaires regarding: * adherence to Mediterranean Diet; * sleep quality; * physical activity; * perceived stress. | Other | patients affected by untreated Periodontitis |
Primary outcome
Treat-to-target after treatment (yes/no)
Time frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Binary outcome defining the success of non-surgical periodontal treatment. The treat-to-target is reached whenever patients at reevaluation have a maximum of 4 sites with Probing Pocket Depth (PPD) >5mm and presence of Bleeding on Probing (BoP)
4 secondary outcomes
Influence of adherence to Mediterranean diet on the success of non-surgical periodontal treatment (treat-to-target)
Time frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Influence of Sleep Quality on the success of non-surgical periodontal treatment (treat-to-target)
Time frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Influence of Physical Activity on the success of non-surgical periodontal treatment (treat-to-target)
Time frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Influence of Perceived Stress on the success of non-surgical periodontal treatment (treat-to-target)
Time frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Surgical Periodontal Treatment and Periodontitis, run by University of Siena 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 4 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: status not confirmed, as of the sponsor's last update on 24 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Discepoli, DDS, MsC, PhD (0577585772, nicola.discepoli2@unisi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treat-to-target after treatment (yes/no) (time frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2021.