Periodontal TherapyNrs_1NCT05297227
Non-surgical Periodontal Therapy: Efficacy of re Treatment for Non-responding Sites.
An observational study of Periodontal Therapy and Non Responding Sites, run by University of Siena.
Trial summary
The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. They were treated with PMPR and Subgingival Instrumentation according to their diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontal Therapy, Non Responding Sites
- What is being tested?
- Non surgical periodontal Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Feb 2023
- How long will I take part?
- 5 Months
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with a Diagnosis of Periodontitis were recruited consecutively after a full mouth clinical examination and radiographic evaluation. The screening and periodontal chart were performed at the Department of Medical Biotechnologies, Unit of Periodontology, University Hospital of Siena, Siena (Italy).
Who may be able to join
- unremarkable general health; age 18-80; minimum of 20 teeth; Periodontitis (Stage 1-4); no antibiotic intake in the previous 6 months;
Who cannot join
- Subgingival instrumentation in the previous 12 months
- No antibiotic intake in the previous 3 months
- A compromised medical condition requiring prophylactic antibiotic coverage
- Pregnant/nursing
- Ongoing drug therapy that might alter the clinical signs and symptoms of periodontitis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Non-surgical Periodontal Therapy: Efficacy of Repeated Subgingival Instrumentation for Non-responding Sites. A Quasi-experimental Study
The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. They were treated with PMPR and Subgingival Instrumentation according to their diagnosis. After 3 months they will be re-evaluated, and non-responding sites (Ppd>=4mm and bop+) will be scheduled for the second session of PMPR and SI. After 2 months they will be re-evaluated and clinical efficacy will be defined.
Read the detailed description
The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. Once included, individuals will receive, by a calibrated examiner, a full-mouth periodontal chart, and accordingly, they will be treated in a multi-step approach, in accordance with the recent clinical guidelines. The treatment will consist of oral hygiene instruction and motivation, risk factor control, professional mechanical plaque removal (PMPR), and subgingival instrumentation (SI): it will be performed by two experienced operators. Thereafter, after 3 months, patients will be evaluated and a new periodontal chart will be performed. The presence of non-responding sites (Ppd>4 and bop+) will be treated with the second session of PMPR plus Subgingival Instrumentation. After 2 months patients will be clinically evaluated and a full periodontal chart will be completed.
- Conditions
- Periodontal Therapy, Non Responding Sites
- Being tested
- Non surgical periodontal Therapy
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
Non-surgical periodontal therapy comprising oral hygiene instruction and motivation, professional mechanical plaque removal, and subgingival instrumentation will be performed. It consists in the use of an ultrasuond (piezoeletric device) and manual curettes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pocket closures
Proportion of pathological periodontal pockets (non responding site) that will be closed (Ppd <5 and bop-) after the second instrumentation
Measured: through study completition, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal TherapyStudies 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
- 63 participants (estimated)
- Target duration
- 5 Months
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
- NCT05297227
- Sponsor's protocol ID
- Nrs_1
- Acronym
- Nrs_1
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 28 Mar 2022
- 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 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-surgical Periodontal Therapy: Efficacy of Repeated Subgingival Instrumentation for Non-responding Sites. A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT05297227
- Acronym / sponsor ID
- Nrs_1 / Nrs_1
- Conditions
- Periodontal Therapy, Non Responding Sites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 28 Mar 2022 (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.
The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. They were treated with PMPR and Subgingival Instrumentation according to their diagnosis. After 3 months they will be re-evaluated, and non-responding sites (Ppd>=4mm and bop+) will be scheduled for the second session of PMPR and SI. After 2 months they will be re-evaluated and clinical efficacy will be defined.
Detailed description
The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. Once included, individuals will receive, by a calibrated examiner, a full-mouth periodontal chart, and accordingly, they will be treated in a multi-step approach, in accordance with the recent clinical guidelines. The treatment will consist of oral hygiene instruction and motivation, risk factor control, professional mechanical plaque removal (PMPR), and subgingival instrumentation (SI): it will be performed by two experienced operators. Thereafter, after 3 months, patients will be evaluated and a new periodontal chart will be performed. The presence of non-responding sites (Ppd>4 and bop+) will be treated with the second session of PMPR plus Subgingival Instrumentation. After 2 months patients will be clinically evaluated and a full periodontal chart will be completed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with a Diagnosis of Periodontitis were recruited consecutively after a full mouth clinical examination and radiographic evaluation. The screening and periodontal chart were performed at the Department of Medical Biotechnologies, Unit of Periodontology, University Hospital of Siena, Siena (Italy).
Key inclusion criteria (1 listed)
- unremarkable general health; age 18-80; minimum of 20 teeth; Periodontitis (Stage 1-4); no antibiotic intake in the previous 6 months;
Key exclusion criteria (5 listed)
- Subgingival instrumentation in the previous 12 months
- No antibiotic intake in the previous 3 months
- A compromised medical condition requiring prophylactic antibiotic coverage
- Pregnant/nursing
- Ongoing drug therapy that might alter the clinical signs and symptoms of periodontitis
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 TherapyNon-surgical periodontal therapy comprising oral hygiene instruction and motivation, professional mechanical plaque removal, and subgingival instrumentation will be performed. It consists in the use of an ultrasuond (piezoeletric device) and manual curettes. | Procedure or surgery | – |
Primary outcome
Number of pocket closures
Time frame: through study completition, 6 months
Proportion of pathological periodontal pockets (non responding site) that will be closed (Ppd <5 and bop-) after the second instrumentation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
Related trials for Periodontal Therapy
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Therapy and Non Responding Sites, run by University of Siena.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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, Prof. (3395256148, nicola.discepoli2@unisi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pocket closures (time frame: through study completition, 6 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 28 Mar 2022.