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Periodontal DiseasesNCT04169139

Controlled Study Comparing REPaiR® and MIST Therapies for Treatment of Periodontitis

A study testing MIST (minimally invasive surgical therapy) in people with Periodontal Diseases, run by McGuire Institute at 1 site in United States.

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

A comparison of laser (REPaiR) compared with minimally invasive surgical therapy for moderate to severe periodontal disease. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases
What is being tested?
MIST (minimally invasive surgical therapy)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
18 May 2018to 15 May 2020
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects 18 to 75 years of age, inclusive.
  • Subjects must be diagnosed with moderate to severe generalized periodontitis (ADA Classification Case Type III or IV) as determined by the investigator.
  • Subjects must have at least one, but up to 2, non-adjacent, qualifying Study Teeth with Pockets (PPD ≥ 6 mm \& intrabony vertical ≥ 3 mm, with base of defect ≥ 3 mm coronal to the tooth apex, and defect angle ≥ 25° as defined by radiograph) on non-adjacent teeth.
  • Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
  • Subjects who are able and willing to adhere to the study visit schedule and other protocol requirements.

Who cannot join

  • Visual inability to identify cementoenamel junction (CEJ) or other landmark for probing measures.
  • Presence of an acute periodontal abscess at the time of MIST or REPaiR treatment steps
  • Mobility > 1 at the time of MIST or REPaiR treatment steps
  • Use of 3rd molars, defects distal to terminal 2nd molars, and teeth treated endodontically as study teeth.
  • Subjects with healing disorders (such as: diabetes mellitus confirmed HgA1C of > 7 within 6-months of screening, cancer, HIV, bone metabolic diseases or Type IV heart disease) that could compromise wound healing and/ or preclude periodontal surgery; or who are taking medications that compromise wound healing, such as chronic steroid use - either inhaler or systemic, calcium channel blockers with clinical evidence of secondary hyperplastic tissue reactions, anti-seizure medications, medications for bone metabolic diseases, radiation or other immuno-suppressive therapy.
  • Traumatic occlusion of study teeth not addressed by occlusal adjustment or splint therapy during the course of the study prior to conclusion of SRP
Show all 16Show fewer
  • Subjects taking intramuscular or intravenous bisphosphonates.
  • Subjects smoking >10 cigarettes per day or an equivalent amount of any other nicotine products, such as smokeless chewing tobacco, nicotine patch, vaporizer, gum, pipe, or cigar smoking.
  • Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration.
  • Anticipated use of systemic antibiotics during the trial or within 30 days of SRP
  • An existing condition that may warrant use of antibiotics during the trial (e.g., ongoing infection noted at Screening Visit, cystic fibrosis or chronic obstructive pulmonary disorder with history of frequent, recurrent lung infections).
  • Use within 30 days prior to Day 1, or a condition for which use is anticipated during trial: topical oral, nasal and systemic corticosteroids.
  • Anticipated use of the agents known to affect periodontal status during the trial and/or use within 30 days prior to Day 1: immunosuppressants, calcium antagonists or phenytoin- - Participation in another clinical study within 90 days prior to Day 1.
  • Subjects who received oral health treatments/interventions within 90 days of Day 1, which the investigator believes may interfere with the periodontal parameters to be assessed in this study (e.g., significant dental and/or gum/oral tissue work).
  • Untreated moderate to severe periodontitis.
  • Subjects, who in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medelis Inc

    Nashville, Tennessee, 37215

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Randomized, Blinded and Controlled Study Comparing REPaiR® and MIST Therapies for Treatment of Moderate to Severe Generalized Periodontitis

A comparison of laser (REPaiR) compared with minimally invasive surgical therapy for moderate to severe periodontal disease.

Read the detailed description

The Trial is a multi-center, randomized, blinded, parallel arm trial of REPaiR therapy (experimental treatment) versus MIST (control therapy) in a maximum of 2 qualifying periodontal study teeth will be treated in each subject. Qualifying teeth will have PPD ≥ 6mm and intrabony vertical ≥ 3 mm, with base of defect ≥ 3 mm coronal to the tooth apex, and defect angle ≥ 25°.

For Subjects already in maintenance therapy and having completed scaling and root planing within the previous 6-months, up to 3 Study Teeth will be selected and SRP conducted on just these teeth, and subjects will be randomized to either Test or Control Therapies (Visit 3). For patients already in maintenance therapy and NOT having completed SRP within the previous 6-months, up to 3 qualifying teeth may be selected, and localized SRP in the study teeth quadrants (Visit 2) can be followed after 4-6 weeks by Visit 3 Therapy on up to 2 Study Teeth. Other subjects not in maintenance therapy and with up to 3 qualifying teeth will be selected at the Screening Visit; then 4-6 weeks following SRP, up to 2 Study Teeth will be selected, and subjects will be randomized to either Test or Control Therapies. Follow-up assessments will be conducted on all subjects by a blinded examiner over a 12-month period.

Being tested
MIST (minimally invasive surgical therapy)
Medical subject headings
Periodontal Diseases

What participants receive

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

  • MIST (minimally invasive surgical therapy)Device

    Also called REPaiR

    REPaiR Periodontal Therapy

Study groups in NCT04169139
Study groupRoleWhat they receive
MIST - minimally invasive surgical therapyActive comparatorBeginning with the "papilla preservation technique" (Takei et al), further improved by Cortellini et al (1995) and combined with minimally invasive approaches (Harrel et al 1995), MIST, using "minimally invasive surgical approaches and micro-surgery instruments," has evolved into a decision tree guideline for treating periodontitis based on periodontal pocket morphology and papilla width/ interdental space (Cortellini P, Tonetti MS (2007) J Clin Periodontol;34(1):87-93).
Receives: Device: MIST (minimally invasive surgical therapy)
REPaiR - laser periodontal therapyExperimentalThe REPaiR regimen is a step-by-step protocol for using the Waterlase Express Er,Cr:YSGG laser for periodontitis. The protocol steps and associated laser delivery is controlled by a computer interface that dictates laser tip, energy and associated air and water mixes. Like MIST, REPaiR uses a set, decision tree approach for periodontal therapy, with prescribed steps and laser settings to quantify and standardize treatment. Potential clinical benefit, as with MIST, are not only effective periodontal therapy with reduced recession compared with traditional surgical approaches, but also reduced patient morbidity (Arnabat-Domínguez et al (2010). Lasers Med Sci;25(3):459-64).
Receives: Device: MIST (minimally invasive surgical therapy)

What is being measured

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

  1. CAL (Clinical Attachment Level)

    Clinical Attachment Level Measured by Periodontal Probe using PPD and Recession

    Measured: 6-months post Sx

Secondary outcomes (1)

  1. Radiographic evidence of bone fill

    Standardized periapical radiographs

    Measured: 6-months post Sx

Timeline

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

  1. First posted19 Nov 2019
  2. Study start18 May 2018
  3. Primary completion15 May 2020
  4. Study completion15 May 2020

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
randomized, blinded, parallel arm trial, non-inferiority comparison of REPaiR therapy (experimental treatment) versus MIST (control therapy)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04169139
Sponsor's protocol ID
BIOLASE001-2017
Status last verified
Mar 2023
First submitted
6 Sep 2019
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Clem D, Heard R, McGuire M, Scheyer ET, Richardson C, Toback G, Gunsolley JC, Geurs N. A comparison of Er,Cr:YSGG laser to minimally invasive surgical technique in the treatment of intrabony defects: Twelve-month results of a multicenter, randomized, controlled study. J Periodontol. 2024 Jul;95(7):621-631. doi: 10.1002/JPER.23-0286. Epub 2023 Oct 17.

    PubMed 37846761

Questions about this trial

What is this clinical trial studying?

A study testing MIST (minimally invasive surgical therapy) in people with Periodontal Diseases, run by McGuire Institute at 1 site in United States.

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 16 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 30 Mar 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 United States. 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?

CAL (Clinical Attachment Level) (time frame: 6-months post Sx). 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 NCT04169139, 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 30 Mar 2023.

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