NCT02925078

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

Completed NA Results posted Last updated 26 October 2020

What this trial tests

NA trial testing Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) in Gingival Tissue in 30 participants. Completed in 16 December 2019.

Timeline

21 November 2016

Primary endpoint
16 December 2019

16 December 2019

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	30
Start date	21 November 2016
Primary completion	16 December 2019
Estimated completion	16 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)

Conditions studied

• Gingival Tissue — all drugs for Gingival Tissue →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Gingival Tissue. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. Primary · 12 months

Radiographic change in remaining bone level (measured in millimeters) between the surgery visit (baseline) and the 12 month follow up visit.

Group	Value	95% CI
<2 mm Mucosa Thickness	0.78	± 0.66
≥2 mm Mucosa Thickness	0.61	± 0.71

Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. Primary · 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.

Group	Value	95% CI
<2 mm Mucosa Thickness	0.65	± 0.62
≥2 mm Mucosa Thickness	1.35	± 0.58

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected during each subject's entire participation in the study (approximately 1.5 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

<2 mm Mucosa Thickness

Serious: 1/14 (7%)

Deaths: 0/14

≥2 mm Mucosa Thickness

Serious: 0/16 (0%)

Deaths: 0/16

Serious adverse events (1 terms)

Reaction	System	<2 mm Mucosa Thickness	≥2 mm Mucosa Thickness
Hip replacement	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Hip replacement.

Data from ClinicalTrials.gov NCT02925078 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of Peri-Implant Phenotype on Implant Therapy Outcomes: A 5-Year Cohort Analysis on Soft Tissue-Level Implants.
   Sabri H, Hazrati P, Tavelli L, Garaicoa-Pazmino C, et al · · 2026 · cited 1× · PMID 41387987 · DOI 10.1111/jcpe.70062