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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT02925078
Collaborator
(none)
30
1
2
36.8
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars: A Prospective Controlled Trial
Actual Study Start Date :
Nov 21, 2016
Actual Primary Completion Date :
Dec 16, 2019
Actual Study Completion Date :
Dec 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: <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.

Device: 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.

Other: ≥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.

Device: 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.

Outcome Measures

Primary Outcome Measures

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan School of Dentistry Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan

Investigators

  • Principal Investigator: Hom-Lay Wang, DDS MSD PhD, Department of Periodontics and Oral Medicine University of Michigan School of Dentistry

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Hom-Lay Wang, DDS, MSD, Ph D, Professor of Dentistry and Director of Graduate Periodontics, University of Michigan
ClinicalTrials.gov Identifier:
NCT02925078
Other Study ID Numbers:
  • HUM00095933
First Posted:
Oct 5, 2016
Last Update Posted:
Oct 26, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title <2 mm Mucosa Thickness ≥2 mm Mucosa Thickness
Arm/Group Description 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. 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.
Period Title: Overall Study
STARTED 14 16
COMPLETED 13 13
NOT COMPLETED 1 3

Baseline Characteristics

Arm/Group Title <2 mm Mucosa Thickness ≥2 mm Mucosa Thickness Total
Arm/Group Description 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. 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 of all reporting groups
Overall Participants 13 13 26
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
9
69.2%
6
46.2%
15
57.7%
>=65 years
4
30.8%
7
53.8%
11
42.3%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
56.54
56.54
56.54
Sex: Female, Male (Count of Participants)
Female
5
38.5%
5
38.5%
10
38.5%
Male
8
61.5%
8
61.5%
16
61.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
United States
13
100%
13
100%
26
100%

Outcome Measures

1. Primary Outcome
Title Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
Description Radiographic change in remaining bone level (measured in millimeters) between the surgery visit (baseline) and the 12 month follow up visit.
Time Frame 12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title <2 mm Mucosa Thickness ≥2 mm Mucosa Thickness
Arm/Group Description 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. 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.
Measure Participants 13 13
Mean (Standard Deviation) [millimeters]
0.78
(0.66)
0.61
(0.71)
2. Primary Outcome
Title Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
Description Change in probing depths (measured in millimeters) around the dental implant between the crown delivery visit and the 12 month follow-up visit.
Time Frame 12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title <2 mm Mucosa Thickness ≥2 mm Mucosa Thickness
Arm/Group Description 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. 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.
Measure Participants 13 13
Mean (Standard Deviation) [millimeters]
0.65
(0.62)
1.35
(0.58)

Adverse Events

Time Frame Adverse event data was collected during each subject's entire participation in the study (approximately 1.5 years)
Adverse Event Reporting Description
Arm/Group Title <2 mm Mucosa Thickness ≥2 mm Mucosa Thickness
Arm/Group Description 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. 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.
All Cause Mortality
<2 mm Mucosa Thickness ≥2 mm Mucosa Thickness
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/14 (0%) 0/16 (0%)
Serious Adverse Events
<2 mm Mucosa Thickness ≥2 mm Mucosa Thickness
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/14 (7.1%) 0/16 (0%)
Musculoskeletal and connective tissue disorders
Hip replacement 1/14 (7.1%) 1 0/16 (0%) 0
Other (Not Including Serious) Adverse Events
<2 mm Mucosa Thickness ≥2 mm Mucosa Thickness
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/14 (0%) 0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Clinical Research Coordinator
Organization University of Michigan
Phone 7347633346
Email aliceou@umich.edu
Responsible Party:
Hom-Lay Wang, DDS, MSD, Ph D, Professor of Dentistry and Director of Graduate Periodontics, University of Michigan
ClinicalTrials.gov Identifier:
NCT02925078
Other Study ID Numbers:
  • HUM00095933
First Posted:
Oct 5, 2016
Last Update Posted:
Oct 26, 2020
Last Verified:
Oct 1, 2020