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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| <2 mm mucosa thickness | Other | A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have <2 mm mucosa thickness. |
|
| ≥2 mm mucosa thickness | Other | A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have ≥2 mm mucosa thickness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) | Device | Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hom-Lay Wang, DDS MSD PhD | Department of Periodontics and Oral Medicine University of Michigan School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8915028 | Background | Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3. doi: 10.1111/j.1600-051x.1996.tb00520.x. | |
| 19885413 | Background | Linkevicius T, Apse P, Grybauskas S, Puisys A. The influence of soft tissue thickness on crestal bone changes around implants: a 1-year prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2009 Jul-Aug;24(4):712-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | <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. |
| FG001 | ≥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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | <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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | millimeters | 12 months |
|
Adverse event data was collected during each subject's entire participation in the study (approximately 1.5 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | <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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | The subject enrolled in the study and at the time did not inform the study team of any need of a hip replacement. 11 months later, the subject told the study team that he had to have his left hip replaced. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | University of Michigan | 7347633346 | aliceou@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2019 | Sep 17, 2020 | Prot_SAP_000.pdf |
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| 20162117 | Background | Balshe AA, Assad DA, Eckert SE, Koka S, Weaver AL. A retrospective study of the survival of smooth- and rough-surface dental implants. Int J Oral Maxillofac Implants. 2009 Nov-Dec;24(6):1113-8. |
| 5249439 | Background | Ochsenbein C, Ross S. A reevaluation of osseous surgery. Dent Clin North Am. 1969 Jan;13(1):87-102. No abstract available. |
| 7623260 | Background | Anderegg CR, Metzler DG, Nicoll BK. Gingiva thickness in guided tissue regeneration and associated recession at facial furcation defects. J Periodontol. 1995 May;66(5):397-402. doi: 10.1902/jop.1995.66.5.397. |
| 3531244 | Background | Claffey N, Shanley D. Relationship of gingival thickness and bleeding to loss of probing attachment in shallow sites following nonsurgical periodontal therapy. J Clin Periodontol. 1986 Aug;13(7):654-7. doi: 10.1111/j.1600-051x.1986.tb00861.x. |
| 9151585 | Background | Abrahamsson I, Berglundh T, Wennstrom J, Lindhe J. The peri-implant hard and soft tissues at different implant systems. A comparative study in the dog. Clin Oral Implants Res. 1996 Sep;7(3):212-9. doi: 10.1034/j.1600-0501.1996.070303.x. |
| 3527955 | Background | Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available. |
| 23537178 | Background | Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. No abstract available. |
| 22945720 | Background | Aparna IN, Dhanasekar B, Lingeshwar D, Gupta L. Implant crest module: a review of biomechanical considerations. Indian J Dent Res. 2012 Mar-Apr;23(2):257-63. doi: 10.4103/0970-9290.100437. |
| 8181824 | Background | Wennerberg A, Albrektsson T, Andersson B. Design and surface characteristics of 13 commercially available oral implant systems. Int J Oral Maxillofac Implants. 1993;8(6):622-33. |
| 41387987 | Derived | Sabri H, Hazrati P, Tavelli L, Garaicoa-Pazmino C, Calatrava J, Wang HL, Barootchi S. Impact of Peri-Implant Phenotype on Implant Therapy Outcomes: A 5-Year Cohort Analysis on Soft Tissue-Level Implants. J Clin Periodontol. 2026 Mar;53(3):394-406. doi: 10.1111/jcpe.70062. Epub 2025 Dec 12. |
| BG001 |
| ≥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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
|
|
| 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. | Posted | Mean | Standard Deviation | millimeters | 12 months |
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| 0 |
| 14 |
| EG001 | ≥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. | 0 | 16 | 0 | 16 | 0 | 16 |
|
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