A Study of Tooth Root Coverage Using a Tissue Graft for Treatment of Gum Recession from Gingivitis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-006568
NCT ID: NCT02657395
Sponsor Protocol Number: 15-006568
About this study
The purpose of this study is to determine if tissue from a fetal calf can serve as an alternative to tissue taken from the patient's own soft palette for dental root coverage procedures.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Adults 18-90 years of age
- Miller Class I & II defects on 1 to 4 adjacent teeth in either the maxillary or mandibular arch
- At least 1 adjacent non-involved tooth on either side of the included recession defects
- Keratinized tissue width of ≥ 2.0 mm
- Periodontal probing depths of 3 mm or less on included teeth
- Plaque index of 2 or less
- Bleeding on probing at 30% or less sites
- Current non-smoker
- No active infected wounds
Exclusion Criteria
- Less than 18 years of age
- Miller Class III, or IV mucogingival defects
- Miller Class I & II defects on greater than 4 adjacent teeth
- Miller Class I & II defects without adjacent non-involved teeth
- CEJ not identifiable
- Root surface restoration at the defect site
- Periodontal probing depths greater than 3 mm
- Plaque index of 2 or greater
- Bleeding on probing at more than 30% of sites
- Uncontrolled oral disease
- Moderate to severe generalized chronic or aggressive periodontitis
- Oral manifestations of a systemic disease
- History of previous root coverage procedure, graft, or GTR
- Current smoker or other tobacco use
- Alcohol abuse problems
- Traumatic occlusion impinging on the recession defect
- Use of intraoral appliances that impinge on the recession defect
- Intra-oral piercings that impinge on the included defect
- Uncontrolled systemic health conditions
- Debilitating systemic or infectious disease
- Diabetes
- Heart Disease
- Uncontrolled heart disease
- Delayed wound healing
- Immunocompromised status due to medication or immune system dysfunction
- Active infection or non-healing wounds
- Currently pregnant or lactating
- Long-term steroid use
- Allergies to bovine products or collagenous materials
- Requirement of prophylaxis antibiotics
- Failure to follow the study protocol
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Daniel Assad, D.D.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available