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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Italy1 site
  • AOU Policlinico G. Rodolico

    Catania, 95124

Other trials in Italy

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 groups in NCT05836298
Study groupRoleWhat they receive
Periodontitis quadrant Scaling root planing (SRP)Placebo comparatorEach selected subject underwent quadrant SRP
Receives: Other: Non-surgical periodontal treatment
MINST treatmentActive comparatorNon 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.

  1. 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.

  1. First posted1 May 2023
  2. Study start2 Jan 2022
  3. Primary completion30 May 2023
  4. Study completion30 May 2023

Resources

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)
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

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.

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