PeriodontitisNCT05088746
Comparing Different Timings for Periodontal Re-evaluation After Non-surgical Periodontal Therapy (NSPT)
An observational study of Periodontitis and Periodontal Pocket, run by University of Parma at 1 site in Italy.
Trial summary
This is a prospective cohort study that aims to describe the difference in terms of percentage of closed pockets (PPD <5 mm and no BOP) when performing the periodontal re-evaluation at 3-4, 6-8 and 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontal Pocket
- What is being tested?
- Non-surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Patients affected by periodontitis
Who may be able to join
- Systemically healthy males and females ≥18 years old
- Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
- Clinical evidence of periodontitis, defined as the presence of interdental clinical attachment loss detectable at ≥2 non-adjacent teeth or buccal or oral clinical attachment loss ≥3mm with pocketing >3 mm detectable at ≥2 teeth (Tonetti et al., 2018)
- Not having received subgingival instrumentation within the previous 12 months
Who cannot join
- Medical history that includes serious medical conditions or transmittable diseases (e.g. serious cardiovascular disease, organ transplant, renal failure, AIDS, viral etc.).
- Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
- In treatment with drugs that induce gingival overgrowth
- History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- History of alcohol or drug abuse.
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing, which can affect interpretation of study results).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective cohort study that aims to describe the difference in terms of percentage of closed pockets (PPD <5 mm and no BOP) when performing the periodontal re-evaluation at 3-4, 6-8 and 12 months.
Fifty-two, ≥18-year old, otherwise healthy, periodontitis patients will be recruited at Centro di Odontoiatria, Università di Parma.
Read the detailed description
This is a prospective cohort study describing the difference in terms of percentage of closed pockets (PPD <5 mm and no BOP) when performing the periodontal re-evaluation at 3-4, 6-8 or 12 months. The trial will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement. The study consists of 7 visits over a period of 15 months.
Visit 1 - Baseline -
- Informed consent, medical/dental history and demographics
- Record concomitant medications and smoking history
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth.
- Standardized peri-apical x-rays for the sites with PPD≥5mm, as per standard of practice (if not already available within the previous 6 months)
- Intra-oral 3D scan
- Oral hygiene instructions and demonstration of self-performed oral hygiene measures
- PROMs questionnaires
- Saliva collection and GCF collection from the deepest pockets (maximum of 5 sites)
Visit 2 and 3 - NSPT - (and extra visit 3.1 and 3.2 if needed) (within 60 days from baseline)
- Update medical/dental history and record adverse events and/or concomitant medications
- NSPT, consisting in the careful removal of hard and soft deposits with ultrasonic instruments at infected sites performed by an experienced clinician following the principles of minimally invasive non-surgical therapy (MINST). A quadrant approach will be adopted and it will be left to the discretion of the clinician to choose whether to instrument 1 or 2 quadrants at a time and the length of session visits. Hence, 2 to 4 sessions of NSPT with an interval of 1 week between each other will be performed. During NSPT, teeth considered hopeless will be extracted as per standard of practice.
- Reinforcement of oral hygiene instructions
- PROMs questionnaires
Extra visits outside the study protocol may be arranged in case the patients need extractions or other dental treatments besides NSPT.
Visit 4 (4-6 weeks from the end of NSPT)
- Update medical/dental history and record adverse events and/or concomitant medications
- Visual inspection of signs of inflammation and plaque
- Supragingival polish and reinforcement of oral hygiene instructions
- PROMs questionnaires
- Intra-oral 3D scan
Visit 5 (3-4 months from the end of NSPT)
- Update medical/dental history and record adverse events and/or concomitant medications
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth.
- PROMs questionnaires
- Intra-oral 3D scan
- Saliva collection and GCF collection from the same sites identified at baseline
- Supragingival polish and reinforcement of oral hygiene instructions
Visit 6 (6-8 months from the end of NSPT)
- Update medical/dental history and record adverse events and/or concomitant medications
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth.
- PROMs questionnaires
- Intra-oral 3D scan
- Saliva collection and GCF collection from the same sites identified at baseline
- Supragingival polish and reinforcement of oral hygiene instructions
Visit 7 (12 months ± 14 days from the end of NSPT)
- Update medical/dental history and record adverse events and/or concomitant medications
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth.
- PROMs questionnaires
- Intra-oral 3D scan
- Standardized peri-apical x-rays
- Saliva collection and GCF collection from the same sites identified at baseline
- Supragingival polish and reinforcement of oral hygiene instructions
Photos and videos may be taken/recorded in any of the study visits for documentation purposes. The subject will not be identifiable from those photos/videos.
- Conditions
- Periodontitis, Periodontal Pocket
- Being tested
- Non-surgical periodontal therapy
- Medical subject headings
- Periodontitis, Periodontal Pocket
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
NSPT will be performed following the principles of minimally invasive non-surgical therapy (MINST) described by Nibali et al. (Nibali et al., 2015, Nibali et al., 2019)
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical periodontal therapy | Not described Receives: Procedure: Non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in percentage of closed pockets (PPD <5 mm and no BOP)
Measured: From baseline to 3-4; 6-8 and 12 months
Secondary outcomes (8)
Changes in probing pocket depth (PPD), recession (REC) and clinical attachment level (CAL)
Measured: From baseline to 3-4; 6-8 and 12 months
Changes in the percentages of sites with PPD reduction ≥2mm
Measured: From baseline to 3-4; 6-8 and 12 months
Changes in the percentages of sites with CAL gain ≥2mm
Measured: From baseline to 3-4; 6-8 and 12 months
Changes in the percentage of deep pockets (PPD≥6 mm)
Measured: From baseline to 3-4; 6-8 and 12 months
Evaluation of global changes in quality of life
In all post NSPT re-evaluations (Visit 4 to 7), a questionnaire (2 questions) will be given to participants to assess changes in quality of life following periodontal therapy
Measured: 4-6 weeks; 3-4 months; 6-8 months; 12 months
changes in oral impact on daily performance (OIDP)
Self-administered questionnaire, it is a composite measure of the impacts of oral health on the quality of life of people.
Measured: From baseline to 4-6 weeks; 3-4 months; 6-8 months; 12 months
Changes in global ratings of periodontal health and quality of life
self administered questionnaire and VAS scale
Measured: From baseline to 4-6 weeks; 3-4 months; 6-8 months; 12 months
Evaluation of changes in patient perception about therapy
VAS scale to evaluate patient perception about therapy
Measured: From non-surgical therapy visit to 4-6 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Elena Calciolari, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088746
- Sponsor's protocol ID
- P-002
- Status last verified
- Jul 2026
- First submitted
- 27 May 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Centro di Odontoiatria is the sponsor for this study. We will be using patient information in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after patient information and using it properly. We will keep identifiable information for 20 years after the study has finished. The only people within the Centro di Odontoiatria who will have access to information that identifies the patients will be people who need to contact them about the research study, and make sure that relevant information about the study is recorded for their care, and to oversee the quality of the study or audit the data collection process. The people who analyse the information will not be able to identify patients and will not be able to find out their name or contact details.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Different Timings for Periodontal Re-evaluation After Non-surgical Periodontal Therapy (NSPT)
- ClinicalTrials.gov ID
- NCT05088746
- Acronym / sponsor ID
- P-002
- Conditions
- Periodontitis, Periodontal Pocket
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Oct 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.
This is a prospective cohort study that aims to describe the difference in terms of percentage of closed pockets (PPD <5 mm and no BOP) when performing the periodontal re-evaluation at 3-4, 6-8 and 12 months.
Fifty-two, ≥18-year old, otherwise healthy, periodontitis patients will be recruited at Centro di Odontoiatria, Università di Parma.
Detailed description
This is a prospective cohort study describing the difference in terms of percentage of closed pockets (PPD <5 mm and no BOP) when performing the periodontal re-evaluation at 3-4, 6-8 or 12 months. The trial will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement. The study consists of 7 visits over a period of 15 months.
Visit 1 - Baseline -
- Informed consent, medical/dental history and demographics
- Record concomitant medications and smoking history
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth.
- Standardized peri-apical x-rays for the sites with PPD≥5mm, as per standard of practice (if not already available within the previous 6 months)
- Intra-oral 3D scan
- Oral hygiene instructions and demonstration of self-performed oral hygiene measures
- PROMs questionnaires
- Saliva collection and GCF collection from the deepest pockets (maximum of 5 sites)
Visit 2 and 3 - NSPT - (and extra visit 3.1 and 3.2 if needed) (within 60 days from baseline)
- Update medical/dental history and record adverse events and/or concomitant medications
- NSPT, consisting in the careful removal of hard and soft deposits with ultrasonic instruments at infected sites performed by an experienced clinician following the principles of minimally invasive non-surgical therapy (MINST). A quadrant approach will be adopted and it will be left to the discretion of the clinician to choose whether to instrument 1 or 2 quadrants at a time and the length of session visits. Hence, 2 to 4 sessions of NSPT with an interval of 1 week between each other will be performed. During NSPT, teeth considered hopeless will be extracted as per standard of practice.
- Reinforcement of oral hygiene instructions
- PROMs questionnaires
Extra visits outside the study protocol may be arranged in case the patients need extractions or other dental treatments besides NSPT.
Visit 4 (4-6 weeks from the end of NSPT)
- Update medical/dental history and record adverse events and/or concomitant medications
- Visual inspection of signs of inflammation and plaque
- Supragingival polish and reinforcement of oral hygiene instructions
- PROMs questionnaires
- Intra-oral 3D scan
Visit 5 (3-4 months from the end of NSPT)
- Update medical/dental history and record adverse events and/or concomitant medications
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth.
- PROMs questionnaires
- Intra-oral 3D scan
- Saliva collection and GCF collection from the same sites identified at baseline
- Supragingival polish and reinforcement of oral hygiene instructions
Visit 6 (6-8 months from the end of NSPT)
- Update medical/dental history and record adverse events and/or concomitant medications
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth.
- PROMs questionnaires
- Intra-oral 3D scan
- Saliva collection and GCF collection from the same sites identified at baseline
- Supragingival polish and reinforcement of oral hygiene instructions
Visit 7 (12 months ± 14 days from the end of NSPT)
- Update medical/dental history and record adverse events and/or concomitant medications
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth.
- PROMs questionnaires
- Intra-oral 3D scan
- Standardized peri-apical x-rays
- Saliva collection and GCF collection from the same sites identified at baseline
- Supragingival polish and reinforcement of oral hygiene instructions
Photos and videos may be taken/recorded in any of the study visits for documentation purposes. The subject will not be identifiable from those photos/videos.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-surgical periodontal therapy | – | Procedure: Non-surgical periodontal therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients affected by periodontitis
Key inclusion criteria (4 listed)
- Systemically healthy males and females ≥18 years old
- Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
- Clinical evidence of periodontitis, defined as the presence of interdental clinical attachment loss detectable at ≥2 non-adjacent teeth or buccal or oral clinical attachment loss ≥3mm with pocketing >3 mm detectable at ≥2 teeth (Tonetti et al., 2018)
- Not having received subgingival instrumentation within the previous 12 months
Key exclusion criteria (7 listed)
- Medical history that includes serious medical conditions or transmittable diseases (e.g. serious cardiovascular disease, organ transplant, renal failure, AIDS, viral etc.).
- Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
- In treatment with drugs that induce gingival overgrowth
- History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- History of alcohol or drug abuse.
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 therapyNSPT will be performed following the principles of minimally invasive non-surgical therapy (MINST) described by Nibali et al. (Nibali et al., 2015, Nibali et al., 2019) | Procedure or surgery | Non-surgical periodontal therapy |
Primary outcome
changes in percentage of closed pockets (PPD <5 mm and no BOP)
Time frame: From baseline to 3-4; 6-8 and 12 months
8 secondary outcomes
Changes in probing pocket depth (PPD), recession (REC) and clinical attachment level (CAL)
Time frame: From baseline to 3-4; 6-8 and 12 months
Changes in the percentages of sites with PPD reduction ≥2mm
Time frame: From baseline to 3-4; 6-8 and 12 months
Changes in the percentages of sites with CAL gain ≥2mm
Time frame: From baseline to 3-4; 6-8 and 12 months
Changes in the percentage of deep pockets (PPD≥6 mm)
Time frame: From baseline to 3-4; 6-8 and 12 months
Evaluation of global changes in quality of life
Time frame: 4-6 weeks; 3-4 months; 6-8 months; 12 months
changes in oral impact on daily performance (OIDP)
Time frame: From baseline to 4-6 weeks; 3-4 months; 6-8 months; 12 months
Changes in global ratings of periodontal health and quality of life
Time frame: From baseline to 4-6 weeks; 3-4 months; 6-8 months; 12 months
Evaluation of changes in patient perception about therapy
Time frame: From non-surgical therapy visit to 4-6 weeks follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. Centro di Odontoiatria is the sponsor for this study. We will be using patient information in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after patient information and using it properly. We will keep identifiable information for 20 years after the study has finished. The only people within the Centro di Odontoiatria who will have access to information that identifies the patients will be people who need to contact them about the research study, and make sure that relevant information about the study is recorded for their care, and to oversee the quality of the study or audit the data collection process. The people who analyse the information will not be able to identify patients and will not be able to find out their name or contact details.
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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?
An observational study of Periodontitis and Periodontal Pocket, run by University of Parma 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
changes in percentage of closed pockets (PPD <5 mm and no BOP) (time frame: From baseline to 3-4; 6-8 and 12 months). 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 7 Jul 2026.