PeriodontitisNCT07524504
Predictive Role of the Full-mouth Plaque Score on the Outcomes of Non-surgical Periodontal Therapy.
An observational study of Periodontitis, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
Oral hygiene quality is a key determinant of outcomes in both non-surgical and surgical periodontal therapy. Previous studies have demonstrated the negative impact of site-specific plaque accumulation on periodontal parameters. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Non-surgical periodontal therapy (NSPT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2026to 15 Dec 2027
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: At least 100 patients with a baseline diagnosis of periodontitis, aged between 18 and 80 years, who have never received periodontal treatment, will be included in the study. Patients will be recruited from the Unit of Periodontology and Dental Hygiene at the Dental Clinic of the Department of Innovative Technologies in Medicine and Dentistry, University of "Gabriele D'Annunzio" of Chieti. Periodontitis will be diagnosed according to the criteria of Tonetti et al., 2018, regardless of grade, stage, or extent of the disease, in cases where periodontal diagnosis and treatment are indicated. Patients must have a confirmed diagnosis of periodontitis and be within the age range of 18 to 80 years. Individuals who have previously received periodontal treatment, are currently taking antibiotics or have taken antibiotics in the past three months, are pregnant or breastfeeding, or have systemic diseases or are on medications that contraindicate periodontal treatment or could influence study outc
Who may be able to join
- Diagnosis of periodontitis according to current guidelines.
- Age between 18 and 80 years.
Who cannot join
- Patients who have previously received periodontal treatment.
- Patients currently on antibiotic therapy or who have taken antibiotics in the past 3 months.
- Pregnant or breastfeeding women.
- Presence of systemic diseases or use of medications in which periodontal treatment is contraindicated or could affect study outcomes (e.g., antihypertensives, antiepileptics, immunosuppressants).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Matteo Serroni, DDS contact
Italy1 site
Clinica Odontoiatrica
Chieti, Chieti, 66100
Matteo Serroni, DDS, +393395824161, serronimatteo@gmail.com
About this study
Official title: Predictive Role of Full-Mouth Plaque Score on the Outcomes of Non-Surgical Periodontal Therapy: A Prospective Cohort Study
Oral hygiene quality is a key determinant of outcomes in both non-surgical and surgical periodontal therapy. Previous studies have demonstrated the negative impact of site-specific plaque accumulation on periodontal parameters. However, to the best of our knowledge, no studies have specifically investigated the correlation between plaque index and the percentage reduction in periodontal pocket depth, nor its association with other periodontal clinical parameters.
The aim of this study is to evaluate the relationship between plaque index and the percentage reduction in periodontal pockets, as well as its association with key periodontal parameters.
Following baseline data collection, patients will undergo non-surgical periodontal therapy in accordance with current guidelines. Clinical outcomes will be reassessed at 3, 6, 9, and 12 months post-treatment.
- Conditions
- Periodontitis
- Being tested
- Non-surgical periodontal therapy (NSPT)
- Keywords
- Periodontitis, Non-surgical periodontal therapy, Re-evaluation
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapy (NSPT)Procedure or surgery
Patients will receive non-surgical periodontal therapy, including professional supragingival (Step 1) and subgingival scaling and root planing (Step 2), according to current guidelines (Herrera et al., 2023). Oral hygiene instructions will be provided at baseline and reinforced at each follow-up visit. Clinical outcomes, including percentage of pocket depth reduction and plaque index (FMPS), will be recorded at 3, 6, 9, and 12 months post-treatment.
| Study group | Role | What they receive |
|---|---|---|
| Non-Surgical Periodontal Therapy Cohort - Plaque Index Evaluation | This cohort includes patients diagnosed with periodontitis who will undergo non-surgical periodontal therapy according to current guidelines. Baseline full mouth plaque index (FMPS) and other periodontal parameters will be recorded. FMPS will be collected at each follow-up visit. Clinical outcomes, including pocket depth reduction and other periodontal measures, will be assessed at 3, 6, 9, and 12 months post-treatment to evaluate the association between oral hygiene and treatment response. Receives: Procedure: Non-surgical periodontal therapy (NSPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of probing pocket depth reduction
The primary outcome is the percentage reduction in probing pocket depth (PPD) at treated sites compared to baseline. PPD will be measured using a calibrated periodontal probe at each follow-up visit (3, 6, 9, and 12 months).
Measured: Baseline, 3, 6 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Serroni, G. d'Annunzio University
- Investigators
- Matteo Serroni, Principal investigator, 'G. D'annunzio' University of Chieti-Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524504
- Sponsor's protocol ID
- 02042026
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Role of Full-Mouth Plaque Score on the Outcomes of Non-Surgical Periodontal Therapy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07524504
- Acronym / sponsor ID
- 02042026
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Non-surgical periodontal therapy, Re-evaluation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 13 Apr 2026 (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.
Oral hygiene quality is a key determinant of outcomes in both non-surgical and surgical periodontal therapy. Previous studies have demonstrated the negative impact of site-specific plaque accumulation on periodontal parameters. However, to the best of our knowledge, no studies have specifically investigated the correlation between plaque index and the percentage reduction in periodontal pocket depth, nor its association with other periodontal clinical parameters.
The aim of this study is to evaluate the relationship between plaque index and the percentage reduction in periodontal pockets, as well as its association with key periodontal parameters.
Following baseline data collection, patients will undergo non-surgical periodontal therapy in accordance with current guidelines. Clinical outcomes will be reassessed at 3, 6, 9, and 12 months post-treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Surgical Periodontal Therapy Cohort - Plaque Index Evaluation | – | Procedure: Non-surgical periodontal therapy (NSPT)This cohort includes patients diagnosed with periodontitis who will undergo non-surgical periodontal therapy according to current guidelines. Baseline full mouth plaque index (FMPS) and other periodontal parameters will be recorded. FMPS will be collected at each follow-up visit. Clinical outcomes, including pocket depth reduction and other periodontal measures, will be assessed at 3, 6, 9, and 12 months post-treatment to evaluate the association between oral hygiene and treatment response. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- At least 100 patients with a baseline diagnosis of periodontitis, aged between 18 and 80 years, who have never received periodontal treatment, will be included in the study. Patients will be recruited from the Unit of Periodontology and Dental Hygiene at the Dental Clinic of the Department of Innovative Technologies in Medicine and Dentistry, University of "Gabriele D'Annunzio" of Chieti. Periodontitis will be diagnosed according to the criteria of Tonetti et al., 2018, regardless of grade, stage, or extent of the disease, in cases where periodontal diagnosis and treatment are indicated. Patients must have a confirmed diagnosis of periodontitis and be within the age range of 18 to 80 years. Individuals who have previously received periodontal treatment, are currently taking antibiotics or have taken antibiotics in the past three months, are pregnant or breastfeeding, or have systemic diseases or are on medications that contraindicate periodontal treatment or could influence study outc
Key inclusion criteria (2 listed)
- Diagnosis of periodontitis according to current guidelines.
- Age between 18 and 80 years.
Key exclusion criteria (4 listed)
- Patients who have previously received periodontal treatment.
- Patients currently on antibiotic therapy or who have taken antibiotics in the past 3 months.
- Pregnant or breastfeeding women.
- Presence of systemic diseases or use of medications in which periodontal treatment is contraindicated or could affect study outcomes (e.g., antihypertensives, antiepileptics, immunosuppressants).
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 therapy (NSPT)Patients will receive non-surgical periodontal therapy, including professional supragingival (Step 1) and subgingival scaling and root planing (Step 2), according to current guidelines (Herrera et al., 2023). Oral hygiene instructions will be provided at baseline and reinforced at each follow-up visit. Clinical outcomes, including percentage of pocket depth reduction and plaque index (FMPS), will be recorded at 3, 6, 9, and 12 months post-treatment. | Procedure or surgery | Non-Surgical Periodontal Therapy Cohort - Plaque Index Evaluation |
Primary outcome
Percentage of probing pocket depth reduction
Time frame: Baseline, 3, 6 9 and 12 months
The primary outcome is the percentage reduction in probing pocket depth (PPD) at treated sites compared to baseline. PPD will be measured using a calibrated periodontal probe at each follow-up visit (3, 6, 9, and 12 months).
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 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Matteo Serroni, DDS contact
Matteo Serroni principal investigator
'G. D'annunzio' University of Chieti-Pescara
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, run by G. d'Annunzio University 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 2 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: opening soon, as of the sponsor's last update on 13 Apr 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?
Contact Matteo Serroni, DDS (+393395824161, serronimatteo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of probing pocket depth reduction (time frame: Baseline, 3, 6 9 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 13 Apr 2026.