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PeriodontitisNCT04236648

Minimally-invasive Non-surgical Treatment in Teeth With Unfavourable Prognosis

A study testing Minimally-invasive non-surgical therapy (MINST) in people with Periodontitis, run by Guy's and St Thomas' NHS Foundation Trust.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a pilot prospective cohort study to assess the efficacy of minimally-invasive non-surgical periodontal therapy (MINST) for the treatment of teeth with unfavourable periodontal prognosis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Periodontitis
What is being tested?
Minimally-invasive non-surgical therapy (MINST)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Feb 2020to 31 Oct 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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70
  • Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)
  • Presence of:
  • N=10: Maxillary or mandibular molars with:
  • Furcation involvement degree II C based on Hamp et al. 1975 horizontal classification and Tarnow \& Fletcher 1984 vertical classification (with concomitant furcation involvement (FI) not exceeding degree II on the other aspects of the same tooth) B. gingival recession ≤ 2mm on furcation site C. mobility maximum degree 2
  • N=10: 'Teeth with bone loss to the apex' (also defined as 'hopeless' by Cortellini et al. 2011), defined as having:
  • radiographic bone loss to the apex or beyond the apex on at least one inter-dental aspect B. presence of severe attachment loss (>10 mm) at the same inter-proximal site/s and at least at one of either the buccal or lingual aspect (Cortellini et al. 2011) C. lack of function because of hypermobility, and/or lack of chewing strength, and/or pain, and/or recurrent periodontal infection/abscesses (Cortellini et al. 2011) D. positive response to vitality testing with electric pulp test (EPT) or previous endodontic treatment considered satisfactory, as judged by the examining clinician
  • Willing to sign informed consent to take part in the study

Who cannot join

  • Smoking (any current or in past 5 years)
  • Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable disease
  • History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
  • Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam
  • Systemic antibiotic therapy during the 3 months preceding the baseline exam
  • History of alcohol or drug abuse, vii) Self-reported pregnancy or lactation
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation
  • Periodontal treatment to the study site within the last 12 months

Trial locations and contacts

No sites are listed yet.

Luigi Nibali, PhD contact

02071887188

luigi.nibali@kcl.ac.uk

About this study

Official title: Clinical and Radiographic Changes Following Minimally-invasive Non-surgical Therapy in Teeth With Unfavourable Prognosis: A Pilot Prospective Cohort Study

This is a pilot prospective cohort study to assess the efficacy of minimally-invasive non-surgical periodontal therapy (MINST) for the treatment of teeth with unfavourable periodontal prognosis. 20 patients who have teeth with unfavourable periodontal prognosis (due to bone loss to the apex or furcation involvement grade II C) will receive minimally-invasive non-surgical treatment (MINST) and will be reassessed up to 12 months after treatment.

Read the detailed description

Twenty patients with advanced periodontitis who have teeth with unfavourable periodontal prognosis (due to bone loss to the apex or furcation involvement grade II C) will be entered in this study, conducted at Guy's Hospital in London, UK. The study has a prospective cohort design, so following baseline assessment, all patients will receive minimally-invasive non-surgical treatment (MINST). A total of 10 visits are planned over a 12-13 months period including initial treatment (MINST) and follow-up appointments.

The primary outcomes are radiographic defect depth (for teeth with bone loss to the apex, n=10) and furcation involvement (for teeth with furcation involvement degree II C, n=10). Paired t-test will be used to detect significant changes between baseline and 12 months for the primary outcomes using the patient as unit of analysis. Additional outcomes will be probing pocket depths (PPD), clinical attachment level (CAL), levels of inflammatory markers and growth factors in gingival crevicular fluid (GCF) and saliva and bacterial detection in periodontal pockets

Conditions
Periodontitis
Being tested
Minimally-invasive non-surgical therapy (MINST)
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimally-invasive non-surgical therapy (MINST)Procedure or surgery

    subgingival root debridement with a minimally-invasive approach using piezoelectric/ultrasonic instruments

Study groups in NCT04236648
Study groupRoleWhat they receive
Minimally-invasive non-surgical therapy (MINST)OtherStudy treatment
Receives: Procedure: Minimally-invasive non-surgical therapy (MINST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic defect depth

    defect depth measured in radiographs in mm (as measured on standardised radiographs)

    Measured: baseline-12 months

  2. Furcation involvement

    furcation involvement measured clinically (as measured based on validated horizontal and vertical furcation involvement scales, by Hamp et al. 1975 and Tarnow 1984). Hamp et al. 1975 goes from 1 to 3 in increasing severity. Tarnow et al. score goes from A to C in increasing severity

    Measured: baseline-12 months

Secondary outcomes (5)

  1. probing pocket depth

    measure of gingival pocket depth (in mm with the use of University of North Carolina(UNC)-15 probe)

    Measured: 0-12 months

  2. clinical attachment level

    measure of pocket + gingival recession (in mm with use of UNC-15 probe)

    Measured: 0-12 months

  3. patient-reported outcomes

    Oral Health Impact Profile (OHIP)-14 questionnaire (standardised scale based on 14 questions). Each question can score from 0 to 4 in increasing severity (maximum total score can be 14x4= 56)

    Measured: 0-12 months

  4. inflammatory response (in saliva and GCF)

    measure of inflammatory cytokines (concentration in saliva and GCF), not restricted to some cytokines but explorative analyses of multiple cytokines by multiplex. The measure will be continuous, expressed for example in picograms/ml

    Measured: 0-12 months

  5. subgingival microbes

    analysis of presence of microbes subgingivally (metagenomic analysis)

    Measured: 0-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start1 Feb 2020 (estimated)
  3. Primary completion31 Oct 2021 (estimated)
  4. Study completion31 Oct 2023 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04236648
Sponsor's protocol ID
Perio-19-001
Status last verified
Jan 2020
First submitted
13 Jan 2020
Last updated
22 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Minimally-invasive non-surgical therapy (MINST) in people with Periodontitis, run by Guy's and St Thomas' NHS Foundation Trust.

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 8 inclusion and 8 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 22 Jan 2020. 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 Luigi Nibali, PhD (02071887188, luigi.nibali@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic defect depth (time frame: baseline-12 months). The study lists 2 primary outcomes in all. 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 NCT04236648.

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 Jan 2020.

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