Controlled Study Comparing REPaiR® and MIST Therapies for Treatment of Periodontitis (NCT04169139) | Clinical Trial Compass
CompletedNot Applicable
Controlled Study Comparing REPaiR® and MIST Therapies for Treatment of Periodontitis
United States54 participantsStarted 2018-05-18
Plain-language summary
A comparison of laser (REPaiR) compared with minimally invasive surgical therapy for moderate to severe periodontal disease.
Who can participate
Age range18 Years – 75 Years
SexALL
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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…