NCT04169139

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: McGuire Institute · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
DEVICE	MIST (minimally invasive surgical therapy)	REPaiR Periodontal Therapy

Timeline

• Start date: 2018-05-18
• Primary completion: 2020-05-15
• Completion: 2020-05-15
• First posted: 2019-11-19
• Last updated: 2023-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study