PeriodontitisNCT05836298
Impact of C-reactive Protein on Non Surgical Periodontal Treatment
A study testing Non-surgical periodontal treatment in people with Periodontitis, run by University of Catania at 1 site in Italy.
Trial summary
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 12-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Non-surgical periodontal treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2022to 30 May 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good condition of general health
- a minimum of 2 teeth for each quadrant with
- Pocket Depth (PD) ranging from 4-6 mm
- no involvement of the furcation
- a minimum of six teeth per quadrant, respectively
Who cannot join
- periodontal therapy during the last 12 months
- assumption of antibiotics during the last 6 months
- pregnancy
- any systemic condition which might affect the effects of the study treatment
- previous or current radiation or immunosuppressive therapies
- use of mouthwash containing antimicrobials during the previous 3 months
Show all 11Show fewer
- no use of hormonal contraceptives
- medication by anti-inflammatory and immunosuppressive drugs
- previous history of hard drinking
- smoking
- class II and III tooth mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of C-reactive Protein on Non Surgical Periodontal Treatment Performed With Mini-invasive Approach
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 12-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Quadrant- Scaling and Root Planing (Q-SRP) treatment versus conventional Minimally invasive non-surgical therapy (MINST) treatment on serum C-reactive protein (CRP) and on Lipoprotein-associated phospholipase A2. Patients were also recalled for supportive periodontal treatment. The main objective was to analyze the effects of MINST or Q-SRP on clinical parameters and serum CRP and Lipoprotein-associated phospholipase A2 changes and if high CRP parameters at baseline influenced non surgical periodontal treatment.
Read the detailed description
This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent. Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of six teeth per quadrant, respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. The primary outcome was the analysis of NSPT performed with either MINST or Q-SRP on periodontal parameters and tooth loss and on serum CRP expression changes between groups after 1- and also 8 years. Furthermore, The secondary objective was to examine the influence and interaction between NSPT protocol (MINST used as a reference) and the duration of treatment on serum CRP changes, as well as whether high baseline CRP levels influenced the efficacy of NSPT after 1-year follow-up. Variations for PD, CAL, FMBS, FMPS, PISA, Lp-PLA2 and CRP were collected and analyzed at 1, 3-, 6-month and at 1-year follow-up.
Patients randomly undergo Q-SRP or MINST non surgical periodontal treatment performed in one session.
All patients underwent an initial session with supragingival debridement. In addition, they received detailed information about the aetiology of periodontitis and individualized oral hygiene instructions, which included inter-dental plaque control and toothbrushing using a modified Bass technique. All participants were provided with the same type of toothbrush and toothpaste§ as well as interdental brushes‖.
The NSPT was achieved by both hand and ultrasonic instrumentation using a No. 5/6/7 tip according to operator preference. In both groups, the ultrasonic device was used with constant water irrigation and with a 20 Hz of frequency at a 60 µn power setting. Patients in the Q-SRP group received quadrant scaling in four different sessions with an interval of 1 week between each quadrant treatment session. Each patient's first session started in the upper right maxillary quadrant.
MINST was performed under local anaesthesia through careful subgingival debridement using ultrasonic scalers with specific thin tips# and Gracey micro-curettes** to minimize the trauma for the soft tissues. Under 3.5x magnification loupes, supra- and subgingival deposits were thoroughly debrided. After the operation, there was no subgingival rinsing to promote the establishment of a stable blood clot.
No mouthwashes, antibiotics or other drugs were prescribed after treatment. At the end of each treatment session, patients were instructed and motivated to perform personal oral hygiene. Moreover, oral hygiene procedures were reinforced at 3 and 6 months after treatment.
After the protocol, patients were enrolled in a maintenance program and recalled for clinical measurements at 1-, 3-, 6-months and 1-year follow-ups. For each patient, a custom-tailored SPT regimen was prescribed to avoid potential mechanical damage at the surgically treated region and enhance plaque reduction using a gentle roll technique for toothbrushing and interproximal cleaning devices.
- Conditions
- Periodontitis
- Being tested
- Non-surgical periodontal treatment
- 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 treatmentOther
Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or MINST
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis quadrant Scaling root planing (SRP) | Placebo comparator | Each selected subject underwent quadrant SRP Receives: Other: Non-surgical periodontal treatment |
| MINST treatment | Active comparator | Non surgical periodontal treatment performed with Minimally invasive non-surgical therapy (MINST) approach Receives: Other: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Serum C-reactive protein changes
evaluation of serum c-reactive protein
Measured: 1-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start2 Jan 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or MINST treatment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, Università degli Studi di Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836298
- Sponsor's protocol ID
- 149-22-PO
- Status last verified
- Aug 2023
- First submitted
- 18 Apr 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Publications
Isola G, Pesce P, Polizzi A, Lo Giudice A, Cicciu M, Scannapieco FA. Effects of minimally invasive non-surgical therapy on C-reactive protein, lipoprotein-associated phospholipase A2, and clinical outcomes in periodontitis patients: A 1-year randomized, controlled clinical trial. J Periodontol. 2024 Oct;95(10):949-962. doi: 10.1002/JPER.23-0518. Epub 2024 May 2.
PubMed 38696664
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of C-reactive Protein on Non Surgical Periodontal Treatment Performed With Mini-invasive Approach
- ClinicalTrials.gov ID
- NCT05836298
- Acronym / sponsor ID
- 149-22-PO
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 1 May 2023 (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.
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 12-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Quadrant- Scaling and Root Planing (Q-SRP) treatment versus conventional Minimally invasive non-surgical therapy (MINST) treatment on serum C-reactive protein (CRP) and on Lipoprotein-associated phospholipase A2. Patients were also recalled for supportive periodontal treatment. The main objective was to analyze the effects of MINST or Q-SRP on clinical parameters and serum CRP and Lipoprotein-associated phospholipase A2 changes and if high CRP parameters at baseline influenced non surgical periodontal treatment.
Detailed description
This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent. Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of six teeth per quadrant, respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. The primary outcome was the analysis of NSPT performed with either MINST or Q-SRP on periodontal parameters and tooth loss and on serum CRP expression changes between groups after 1- and also 8 years. Furthermore, The secondary objective was to examine the influence and interaction between NSPT protocol (MINST used as a reference) and the duration of treatment on serum CRP changes, as well as whether high baseline CRP levels influenced the efficacy of NSPT after 1-year follow-up. Variations for PD, CAL, FMBS, FMPS, PISA, Lp-PLA2 and CRP were collected and analyzed at 1, 3-, 6-month and at 1-year follow-up.
Patients randomly undergo Q-SRP or MINST non surgical periodontal treatment performed in one session.
All patients underwent an initial session with supragingival debridement. In addition, they received detailed information about the aetiology of periodontitis and individualized oral hygiene instructions, which included inter-dental plaque control and toothbrushing using a modified Bass technique. All participants were provided with the same type of toothbrush and toothpaste§ as well as interdental brushes‖.
The NSPT was achieved by both hand and ultrasonic instrumentation using a No. 5/6/7 tip according to operator preference. In both groups, the ultrasonic device was used with constant water irrigation and with a 20 Hz of frequency at a 60 µn power setting. Patients in the Q-SRP group received quadrant scaling in four different sessions with an interval of 1 week between each quadrant treatment session. Each patient's first session started in the upper right maxillary quadrant.
MINST was performed under local anaesthesia through careful subgingival debridement using ultrasonic scalers with specific thin tips# and Gracey micro-curettes** to minimize the trauma for the soft tissues. Under 3.5x magnification loupes, supra- and subgingival deposits were thoroughly debrided. After the operation, there was no subgingival rinsing to promote the establishment of a stable blood clot.
No mouthwashes, antibiotics or other drugs were prescribed after treatment. At the end of each treatment session, patients were instructed and motivated to perform personal oral hygiene. Moreover, oral hygiene procedures were reinforced at 3 and 6 months after treatment.
After the protocol, patients were enrolled in a maintenance program and recalled for clinical measurements at 1-, 3-, 6-months and 1-year follow-ups. For each patient, a custom-tailored SPT regimen was prescribed to avoid potential mechanical damage at the surgically treated region and enhance plaque reduction using a gentle roll technique for toothbrushing and interproximal cleaning devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or MINST treatment
| Arm | Type | Receives |
|---|---|---|
| Periodontitis quadrant Scaling root planing (SRP) | Placebo comparator | Other: Non-surgical periodontal treatmentEach selected subject underwent quadrant SRP |
| MINST treatment | Active comparator | Other: Non-surgical periodontal treatmentNon surgical periodontal treatment performed with Minimally invasive non-surgical therapy (MINST) approach |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- good condition of general health
- a minimum of 2 teeth for each quadrant with
- Pocket Depth (PD) ranging from 4-6 mm
- no involvement of the furcation
- a minimum of six teeth per quadrant, respectively
Key exclusion criteria (11 listed)
- periodontal therapy during the last 12 months
- assumption of antibiotics during the last 6 months
- pregnancy
- any systemic condition which might affect the effects of the study treatment
- previous or current radiation or immunosuppressive therapies
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 treatmentEach selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or MINST | Other | MINST treatment, Periodontitis quadrant Scaling root planing (SRP) |
Primary outcome
Reduction of Serum C-reactive protein changes
Time frame: 1-year follow up
evaluation of serum c-reactive protein
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 22 Aug 2023.
- Derived from this study: PubMed 38696664Isola G, Pesce P, Polizzi A, Lo Giudice A, Cicciu M, Scannapieco FA. Effects of minimally invasive non-surgical therapy on C-reactive protein, lipoprotein-associated phospholipase A2, and clinical outcomes in periodontitis patients: A 1-year randomized, controlled clinical trial. J Periodontol. 2024 Oct;95(10):949-962. doi: 10.1002/JPER.23-0518. Epub 2024 May 2.
- Individual participant dataSharing planned: Yes. Study results
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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.
Gaetano Isola principal investigator
Università degli Studi di Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment in people with Periodontitis, run by University of Catania 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 5 inclusion and 11 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 22 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Reduction of Serum C-reactive protein changes (time frame: 1-year follow up). 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 NCT05836298, which also lists 1 linked publication.
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 22 Aug 2023.