Clinical trial NCT02925078: Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars
Official title: The Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars: A Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Tissue
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
timeFrame: 12 months
measure: Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
name: Hom-Lay Wang, DDS MSD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
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