Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars
NCT ID: NCT02925078
Last Updated: 2020-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-11-21
2019-12-16
Brief Summary
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Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant with smooth collar.
Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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<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.
≥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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Hom-Lay Wang, DDS, MSD, Ph D
Professor of Dentistry and Director of Graduate Periodontics
Principal Investigators
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Hom-Lay Wang, DDS MSD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
Locations
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University of Michigan School of Dentistry
Ann Arbor, Michigan, United States
Countries
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References
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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.
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.
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.
Ochsenbein C, Ross S. A reevaluation of osseous surgery. Dent Clin North Am. 1969 Jan;13(1):87-102. No abstract available.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HUM00095933
Identifier Type: -
Identifier Source: org_study_id