Dimensional Changes: Randomized Clinical Trial

Launched by UNIVERSITY OF IOWA · Jan 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different types of gum grafts affect patients with thin gum tissues who have gum recession. Specifically, researchers want to find out if placing a gum graft on completely bare bone (called full thickness) is as effective as placing it on bone with some tissue still present (called split thickness). Both types of grafts will be evaluated over a year to see how well they heal and how they affect patients’ oral health and comfort.

To participate in this study, you must be between 18 and 95 years old and have certain conditions, like thin gum tissue and shallow spaces between your gums and cheeks. You should also not currently smoke and need to be willing to follow the study's instructions. If you join, you will attend eight visits over the course of a year, including a screening, surgery, and multiple follow-ups to check on your healing progress. This trial is not yet recruiting, but it aims to help improve treatments for gum recession in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients 18-95 years of age
• • Inactive periodontal disease
• • Lack of, or an insufficient (less than 2 millimeters) band of keratinized tissue width on the buccal site (closest to the cheek)
• • Shallow vestibule depth (the space between the soft tissue (lips and cheeks), and the teeth and gums)
• • Thin gingival phenotype (less than 1.5mm of gum tissue depth).
• • Aberrant frenum attachment in need of free-epithelized gingival grafts.
• • At least one RT1, 2, or 3 (Cairo's classification) gingival recession defect on the mandibular anterior sextant (Teeth #22-27).
• • Non-smokers or past smokers (those who have stopped at minimum 6 months ago).
• • Patient willing and able to follow instruction related to the study procedures.
• Exclusion Criteria:
• • Previous soft tissue augmentation procedures at the area of interest.
• • Current smokers (Light smokers meaning less than 10 cigarettes/day, heavy smokers meaning more than 10 cigarettes/day, or social smokers)
• • Uncontrolled systemic disease (uncontrolled diabetes defined by blood sugar HbA1c greater than 7%)
• • Any active local or systemic infections
• • Any diseases or medications that may compromise normal wound healing
• • Currently receiving chemotherapy or radiotherapy or a history of radiotherapy in head and neck area.
• • Severe hematologic (blood) disorders
• • Pregnancy or nursing mother
• • Patients undergoing orthodontic therapy
• • Patients taking antibiotics in the past 3 months