PeriodontitisNCT04826926
Timing of Periodontal Re-evaluation After Non-surgical Periodontal Therapy
A study testing Procedure/Surgery: Non Surgical Periodontal Therapy in people with Periodontitis, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Literature on non surgical periodontal therapy (NSPT) shows lack of clarity in reporting information on re-evaluation timing and clinical response. If the re-evaluation was done shortly after NSPT, this is also likely to have an influence on the surgical treatment plan. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Procedure/Surgery: 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
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 10 Jan 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Periodontitis stage III-IV
- Full-mouth plaque score (FMPS) < 25% at the 1-month re-evaluation
- Full-mouth bleeding score (FMBS) < 25% at the 1-month re-evaluation
- Signed informed consent
Who cannot join
- Age < 18 yo
- Pregnancy or lactation
- Heavy smokers (>10 die)
- Conditions or diseases influencing periodontal healing
- Patients that cannot complete the 6 months follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Timing of Re-evaluation After Non-surgical Periodontal Therapy on Clinical Parameters and Decision-making. A Prospective Clinical Trial
Literature on non surgical periodontal therapy (NSPT) shows lack of clarity in reporting information on re-evaluation timing and clinical response. If the re-evaluation was done shortly after NSPT, this is also likely to have an influence on the surgical treatment plan. The aim of this prospective clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, PD reduction, comprehensive treatment plan, and costs for the patient.
- Conditions
- Periodontitis
- Being tested
- Procedure/Surgery: Non Surgical Periodontal Therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Surgery: 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 treatment NSPT | Experimental | 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: Procedure/Surgery: Non Surgical Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pocket closure % (0 - 100 % with higher percentage indicating better status)
Percentage of pockets ≥ 5 mm that converted to ≤4 mm at the completion of NSPT
Measured: [Time Frame: Baseline, 1 month, 3 months and 6 months 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: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes.
The distance between the cementoenamel junction (CEJ) and the base of the pocket.
Measured: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes.
The sum of Probing pocket depth (PD, mm) and Recession (Rec, mm)
Measured: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Monetary cost for the treatment plan in €
Cost in € for the proposed treatment plan for patient at each re-evaluation timing based on the Italian Dental Association survey of charges for periodontal services for general dentists and periodontists.
Measured: [Time Frame: 1 month, 3 months and 6 months 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 posted1 Apr 2021
- Study start1 Apr 2021
- Primary completion15 Oct 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826926
- Sponsor's protocol ID
- UTurin02
- Status last verified
- Jan 2022
- First submitted
- 23 Mar 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baima G, Dabdoub S, Thumbigere-Math V, Ribaldone DG, Caviglia GP, Tenori L, Fantato L, Vignoli A, Romandini M, Ferrocino I, Aimetti M. Multi-Omics Signatures of Periodontitis and Periodontal Therapy on the Oral and Gut Microbiome. J Periodontal Res. 2025 Dec;60(12):1237-1253. doi: 10.1111/jre.70055. Epub 2025 Nov 27.
PubMed 41307322Baima G, Ferrocino I, Del Lupo V, Colonna E, Thumbigere-Math V, Caviglia GP, Franciosa I, Mariani GM, Romandini M, Ribaldone DG, Romano F, Aimetti M. Effect of Periodontitis and Periodontal Therapy on Oral and Gut Microbiota. J Dent Res. 2024 Apr;103(4):359-368. doi: 10.1177/00220345231222800. Epub 2024 Feb 16.
PubMed 38362600Ferrarotti F, Baima G, Rendinelli M, Citterio F, Mariani GM, Mussano F, Romano F, Romandini M, Aimetti M. Pocket closure after repeated subgingival instrumentation: a stress test to the EFP guideline for stage III-IV periodontitis. Clin Oral Investig. 2023 Nov;27(11):6701-6708. doi: 10.1007/s00784-023-05279-6. Epub 2023 Sep 29.
PubMed 37773418
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Timing of Re-evaluation After Non-surgical Periodontal Therapy on Clinical Parameters and Decision-making. A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04826926
- Acronym / sponsor ID
- UTurin02
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 1 Apr 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.
Literature on non surgical periodontal therapy (NSPT) shows lack of clarity in reporting information on re-evaluation timing and clinical response. If the re-evaluation was done shortly after NSPT, this is also likely to have an influence on the surgical treatment plan. The aim of this prospective clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, PD reduction, comprehensive treatment plan, and costs for the patient.
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 treatment NSPT | Experimental | Procedure: Procedure/Surgery: 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Periodontitis stage III-IV
- Full-mouth plaque score (FMPS) < 25% at the 1-month re-evaluation
- Full-mouth bleeding score (FMBS) < 25% at the 1-month re-evaluation
- Signed informed consent
Key exclusion criteria (5 listed)
- Age < 18 yo
- Pregnancy or lactation
- Heavy smokers (>10 die)
- Conditions or diseases influencing periodontal healing
- Patients that cannot complete the 6 months follow-up
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 |
|---|---|---|
| Procedure/Surgery: 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 treatment NSPT |
Primary outcome
Change in pocket closure % (0 - 100 % with higher percentage indicating better status)
Time frame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Percentage of pockets ≥ 5 mm that converted to ≤4 mm at the completion of NSPT
4 secondary outcomes
Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status)
Time frame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes.
Time frame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes.
Time frame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Monetary cost for the treatment plan in €
Time frame: [Time Frame: 1 month, 3 months and 6 months 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 2 Mar 2022.
- Derived from this study: PubMed 41307322Baima G, Dabdoub S, Thumbigere-Math V, Ribaldone DG, Caviglia GP, Tenori L, Fantato L, Vignoli A, Romandini M, Ferrocino I, Aimetti M. Multi-Omics Signatures of Periodontitis and Periodontal Therapy on the Oral and Gut Microbiome. J Periodontal Res. 2025 Dec;60(12):1237-1253. doi: 10.1111/jre.70055. Epub 2025 Nov 27.
- Derived from this study: PubMed 38362600Baima G, Ferrocino I, Del Lupo V, Colonna E, Thumbigere-Math V, Caviglia GP, Franciosa I, Mariani GM, Romandini M, Ribaldone DG, Romano F, Aimetti M. Effect of Periodontitis and Periodontal Therapy on Oral and Gut Microbiota. J Dent Res. 2024 Apr;103(4):359-368. doi: 10.1177/00220345231222800. Epub 2024 Feb 16.
- Derived from this study: PubMed 37773418Ferrarotti F, Baima G, Rendinelli M, Citterio F, Mariani GM, Mussano F, Romano F, Romandini M, Aimetti M. Pocket closure after repeated subgingival instrumentation: a stress test to the EFP guideline for stage III-IV periodontitis. Clin Oral Investig. 2023 Nov;27(11):6701-6708. doi: 10.1007/s00784-023-05279-6. Epub 2023 Sep 29.
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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 Procedure/Surgery: Non Surgical Periodontal Therapy in people with Periodontitis, 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 4 inclusion and 5 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 2 Mar 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 pocket closure % (0 - 100 % with higher percentage indicating better status) (time frame: [Time Frame: Baseline, 1 month, 3 months and 6 months 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 NCT04826926, which also lists 3 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 2 Mar 2022.