Gingival Tissue
Conditions
Brief summary
The primary objective of this study is to compare the amount of implant marginal bone loss radiographically and probing depth in between thin and thick mucosa group that will receive a machined collar implant. Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant with smooth collar.
Detailed description
Twenty eight adult patients who fulfill the inclusion criteria will be divided into 2 groups based upon the mucosa thickness (\<2 mm and ≥2 mm). A signed written informed consent will be obtained from all subjects. Subjects will not be screened or treated until an informed consent has been obtained. Patient information will be protected according to the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). The enrolled patients will receive implants with 1 mm polished collar. Implants will be restored at 4 (±1) months after placement. Outcome analyses will be performed until 1 (±1 month) year after loading and clinical and radiographic parameters will be evaluated to compare clinical outcomes between groups. The primary outcome is implant marginal bone loss and probing depth from clinical and radiographic measurements.
Interventions
DEVICEBiohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)
Placement of implant in a subject with \<2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness.
Sponsors
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or Female * Aged ≥18 * In need of one dental implant in the Maxillary or Mandibular area, can be an anterior, premolar, or 1st molar tooth * Natural adjacent teeth * Bone height of ≥10mm * Bone width of ≥5mm * Good oral hygiene * Stable periodontium * Willingness to fulfill all study requirements
Exclusion criteria
* Need bone augmentation * Need one dental implant that is a 2nd or 3rd molar tooth * Current smoker or quit smoking less than one year * Pregnant or plan to get pregnant * Uncontrolled diabetes (HbA1C \> 7) * Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections ) * Current use of oral bisphosphonates * History of IV bisphosphonates * History of radiation therapy in the head and neck area within 4 years * Poor oral hygiene (plaque score more than 40% based on O'Leary plaque score) * Once a group has been filled, subjects who meet the criteria of that group will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. | 12 months | Radiographic change in remaining bone level (measured in millimeters) between the surgery visit (baseline) and the 12 month follow up visit. |
| Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. | 12 months | Change in probing depths (measured in millimeters) around the dental implant between the crown delivery visit and the 12 month follow-up visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| <2 mm Mucosa Thickness A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have \<2 mm mucosa thickness.
Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT): Placement of implant in a subject with \<2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness. | 13 |
| ≥2 mm Mucosa Thickness A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have ≥2 mm mucosa thickness.
Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT): Placement of implant in a subject with \<2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness. | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | ≥2 mm Mucosa Thickness | Total | <2 mm Mucosa Thickness |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 11 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 15 Participants | 9 Participants |
| Age, Continuous | 56.54 years | 56.54 years | 56.54 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 13 participants | 26 participants | 13 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 16 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 1 / 14 | 0 / 16 |
Outcome results
Primary
Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
Change in probing depths (measured in millimeters) around the dental implant between the crown delivery visit and the 12 month follow-up visit.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| <2 mm Mucosa Thickness | Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. | 0.65 millimeters | Standard Deviation 0.62 |
| ≥2 mm Mucosa Thickness | Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. | 1.35 millimeters | Standard Deviation 0.58 |
Primary
Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
Radiographic change in remaining bone level (measured in millimeters) between the surgery visit (baseline) and the 12 month follow up visit.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| <2 mm Mucosa Thickness | Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. | 0.78 millimeters | Standard Deviation 0.66 |
| ≥2 mm Mucosa Thickness | Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. | 0.61 millimeters | Standard Deviation 0.71 |