N/A N=30 Other

Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars

Gingival Tissue

Bottom Line

View on ClinicalTrials.gov: NCT02925078 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Oct 2020

Primary outcome: Primary: Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. — 0.78; 0.61 millimeters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.	0.78; 0.61	—
PRIMARY Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.	0.65; 1.35	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02925078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.