Trial Outcomes & Findings for Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars (NCT NCT02925078)

NCT ID: NCT02925078

Last Updated: 2020-10-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2020-10-26

Participant Flow

Participant milestones

Measure	<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.
Overall Study STARTED	14	16
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	<2 mm Mucosa Thickness n=13 Participants 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 n=13 Participants 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 n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=13 Participants	6 Participants n=13 Participants	15 Participants n=26 Participants
Age, Categorical >=65 years	4 Participants n=13 Participants	7 Participants n=13 Participants	11 Participants n=26 Participants
Age, Continuous	56.54 years n=13 Participants	56.54 years n=13 Participants	56.54 years n=26 Participants
Sex: Female, Male Female	5 Participants n=13 Participants	5 Participants n=13 Participants	10 Participants n=26 Participants
Sex: Female, Male Male	8 Participants n=13 Participants	8 Participants n=13 Participants	16 Participants n=26 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	13 participants n=13 Participants	13 participants n=13 Participants	26 participants n=26 Participants

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	<2 mm Mucosa Thickness n=13 Participants 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 n=13 Participants 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.
Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.	0.78 millimeters Standard Deviation 0.66	0.61 millimeters Standard Deviation 0.71

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	<2 mm Mucosa Thickness n=13 Participants 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 n=13 Participants 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.
Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.	0.65 millimeters Standard Deviation 0.62	1.35 millimeters Standard Deviation 0.58

Adverse Events

<2 mm Mucosa Thickness

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

≥2 mm Mucosa Thickness

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	<2 mm Mucosa Thickness n=14 participants at risk 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 n=16 participants at risk 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.
Musculoskeletal and connective tissue disorders Hip replacement	7.1% 1/14 • Number of events 1 • Adverse event data was collected during each subject's entire participation in the study (approximately 1.5 years)	0.00% 0/16 • Adverse event data was collected during each subject's entire participation in the study (approximately 1.5 years)

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Coordinator

University of Michigan

Phone: 7347633346

Email: aliceou@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place