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

NCT04169139 | Completed FDA Device

• 1 other identifier: BIOLASE001-2017
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• CAL (Clinical Attachment Level)

  Clinical Attachment Level Measured by Periodontal Probe using PPD and Recession

  6-months post Sx

Secondary Outcomes (1)

• Radiographic evidence of bone fill

  6-months post Sx

Other Outcomes (2)

• Patient Reported Outcome for Pain

  Daily for 7-days following Sx

• Patient Reported Outcome for Satisfaction

  1-month, 3-months and 6-months post SX

Study Arms (2)

MIST - minimally invasive surgical therapy

ACTIVE COMPARATOR

Beginning 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).

Device: MIST (minimally invasive surgical therapy)

REPaiR - laser periodontal therapy

EXPERIMENTAL

The 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).

Device: MIST (minimally invasive surgical therapy)

Interventions

MIST (minimally invasive surgical therapy) DEVICE

REPaiR Periodontal Therapy

Also known as: REPaiR

MIST - minimally invasive surgical therapy; REPaiR - laser periodontal therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• McGuire Institute: lead
• Biolase Inc: collaborator

Study Sites (1)

Medelis Inc

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Donald Clem, DDS

  Regenerative Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Examiners are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, blinded, parallel arm trial, non-inferiority comparison of REPaiR therapy (experimental treatment) versus MIST (control therapy)

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: November 19, 2019
• Study Start: May 18, 2018
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

US (1)