Clinical trial NCT04169139: Controlled Study Comparing REPaiR® and MIST Therapies for Treatment of Periodontitis
Official title: A Prospective, Multicenter, Randomized, Blinded and Controlled Study Comparing REPaiR® and MIST Therapies for Treatment of Moderate to Severe Generalized Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: McGuire Institute
Sponsor class: INDUSTRY
Collaborators: name: Biolase Inc
First posted: 2019-11-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, blinded, parallel arm trial, non-inferiority comparison of REPaiR therapy (experimental treatment) versus MIST (control therapy)
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: CAL (Clinical Attachment Level)
timeFrame: 6-months post Sx
Secondary outcomes:
measure: Radiographic evidence of bone fill
timeFrame: 6-months post Sx
Other outcomes:
measure: Patient Reported Outcome for Pain
timeFrame: Daily for 7-days following Sx
measure: Patient Reported Outcome for Satisfaction
timeFrame: 1-month, 3-months and 6-months post SX
Locations:
city: Nashville
country: United States
facility: Medelis Inc
state: Tennessee
Study officials:
affiliation: Regenerative Solutions
name: Donald Clem, DDS
role: PRINCIPAL_INVESTIGATOR
References: