Gingival Diseases
Conditions
Keywords
Autologous; Collagen Matrix; Keratinized Tissue
Brief summary
A split-mouth study comparing soft tissue augmentation results using free gingival graft (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT) around teeth with insufficient (\< 2mm) KT.
Detailed description
A single-blind, randomized, controlled, split-mouth study of 30 subjects with insufficient zones of KT (\< 2mm). The study utilized a within subject treatment comparison design to establish non-inferiority of the test (CM) versus control (FGG) therapy. The primary efficacy endpoint was KT width at 6-months. Secondary endpoints included traditional periodontal measures, such as clinical attachment, recession and bleeding on probing. Patient reported pain, discomfort and esthetic satisfaction were also recorded. Biopsies were obtained at 6-months.
Interventions
A type I and III porcine collagen matrix, as cleared by FDA (K012423)
DEVICEFree Gingival Graft
Autogenous, full-thickness soft tissue graft harvested from patient's palate.
Sponsors
Perio Health Professionals, PLLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* At least two non-adjacent teeth in contralateral quadrants of the same jaw with \< 2mm of KT that requires soft tissue grafting (1-4 teeth may be treated). In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment). The number of teeth treated must be the same on the test and control sites. * Root coverage is not desired at the time of grafting. * Females of childbearing potential must have a documented negative urine pregnancy test. * Read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF). * Able and willing to follow study procedures and instructions. * Multi-rooted teeth may be treated but will not be included as study teeth
Exclusion criteria
* Vestibule depth of less than 7mm from base of recession, and/or teeth with Miller Grade 2 or higher mobility. * Any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude periodontal surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. * Presence of acute infectious lesions in the areas intended for surgery. * History of any tobacco use within the last six months. * Taking intramuscular or intravenous bisphosphonates. * Known hypersensitivity to collagen products, and/or allergy to iodine or shellfish. * Participating in other clinical studies involving therapeutic intervention (either medical or dental). * Previously undergone a gingival grafting procedure on the test or control teeth or the teeth adjacent to the study site. * Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration following entrance into the study. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Keratinized Tissue Width | 6 months | Change in Keratinized Tissue width |
Participant flow
Recruitment details
Our study sample was derived from the population of patients who presented at our practice between 11-3-2010 and 3-16-2011 and met predetermined selection criteria
Participants by arm
| Arm | Count |
|---|---|
| Xenogeneic Collagen Matrix Versus Free Gingival Graft free gingival graft versus a xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Xenogeneic Collagen Matrix Versus Free Gingival Graft |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 51.9 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Keratinized Tissue Width
Change in Keratinized Tissue width
Time frame: 6 months
Population: Sample size was determined using 80% power fans assuming a paired t-test of non-inferiority with a non-inferiority margin of 1.0 mm, a within-subject standard deviation of 1.0 mm, and a one-sided alpha of 0.05, resulting in a sample size of 27. To account for potential loss-to-follow-up, 30 subjects were enrolled in the trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Free Gingival Graft | Keratinized Tissue Width | 4.42 mm | Standard Deviation 0.64 |
| Xenogeneic Collagen Matrix | Keratinized Tissue Width | 2.92 mm | Standard Deviation 0.88 |
p-value: <0.0001Wilcoxon (Mann-Whitney)