Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: <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. |
Device: 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.
|
Other: ≥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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Michigan School of Dentistry | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Hom-Lay Wang, DDS MSD PhD, Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
Study Documents (Full-Text)
More Information
Publications
- Abrahamsson I, Berglundh T, Wennström 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.
- 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. Review.
- 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.
- 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. Review.
- 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.
- Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3.
- 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.
- 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.
- Ochsenbein C, Ross S. A reevaluation of osseous surgery. Dent Clin North Am. 1969 Jan;13(1):87-102.
- 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. Review.
- 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.
- HUM00095933
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | <2 mm Mucosa Thickness | ≥2 mm Mucosa Thickness |
---|---|---|
Arm/Group Description | 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. | 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. |
Period Title: Overall Study | ||
STARTED | 14 | 16 |
COMPLETED | 13 | 13 |
NOT COMPLETED | 1 | 3 |
Baseline Characteristics
Arm/Group Title | <2 mm Mucosa Thickness | ≥2 mm Mucosa Thickness | Total |
---|---|---|---|
Arm/Group Description | 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. | 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. | Total of all reporting groups |
Overall Participants | 13 | 13 | 26 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
9
69.2%
|
6
46.2%
|
15
57.7%
|
>=65 years |
4
30.8%
|
7
53.8%
|
11
42.3%
|
Age (years) [Mean (Full Range) ] | |||
Mean (Full Range) [years] |
56.54
|
56.54
|
56.54
|
Sex: Female, Male (Count of Participants) | |||
Female |
5
38.5%
|
5
38.5%
|
10
38.5%
|
Male |
8
61.5%
|
8
61.5%
|
16
61.5%
|
Race and Ethnicity Not Collected (Count of Participants) | |||
Count of Participants [Participants] |
0
0%
|
||
Region of Enrollment (participants) [Number] | |||
United States |
13
100%
|
13
100%
|
26
100%
|
Outcome Measures
Title | Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | <2 mm Mucosa Thickness | ≥2 mm Mucosa Thickness |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [millimeters] |
0.78
(0.66)
|
0.61
(0.71)
|
Title | Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | <2 mm Mucosa Thickness | ≥2 mm Mucosa Thickness |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [millimeters] |
0.65
(0.62)
|
1.35
(0.58)
|
Adverse Events
Time Frame | Adverse event data was collected during each subject's entire participation in the study (approximately 1.5 years) | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | <2 mm Mucosa Thickness | ≥2 mm Mucosa Thickness | ||
Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
<2 mm Mucosa Thickness | ≥2 mm Mucosa Thickness | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/14 (0%) | 0/16 (0%) | ||
Serious Adverse Events |
||||
<2 mm Mucosa Thickness | ≥2 mm Mucosa Thickness | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/14 (7.1%) | 0/16 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
Hip replacement | 1/14 (7.1%) | 1 | 0/16 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
<2 mm Mucosa Thickness | ≥2 mm Mucosa Thickness | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/14 (0%) | 0/16 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Clinical Research Coordinator |
---|---|
Organization | University of Michigan |
Phone | 7347633346 |
aliceou@umich.edu |
- HUM00095933