A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing

A Controlled, Double-Blind, Randomized, Parallel-Arm, Clinical Trial to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments for Enhanced Oral Mucosal Healing

The purpose of this study is to determine which implant-abutment design is more likely to promote early soft-tissue healing processes and/or will enhance longitudinal peri-implant bone and soft-tissue health.

Study Overview

• Status: Completed
• Conditions: Jaw, Edentulous, Partially
• Intervention / Treatment: Device: Dental implant-abutments

Detailed Description

The study will assess the integrity of the peri-implant oral soft-tissue attachment to implant abutments by comparing tissue responses to a laser-ablated implant-abutment and an implant-abutment manufactured with a smooth surface.

Investigators will assess the initial post-surgical peri-implant attachment-seal and will test whether or not the tissue-abutment interface re-forms with equal integrity when the abutment is removed and replaced with a new abutment.

Data will include histological, radiographic, clinical, and subjective aesthetics to compare the effectiveness of two abutment designs. Both devices are supplied by the BioHorizons Implant Systems Inc. of Birmingham, Alabama; the abutments are analogous in design and material except the test device has a laser-ablated surface and the control abutment is smooth.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • University of Alabama at Birmingham School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. At least 19 years old
2. Healthy enough to under go treatment
3. Have one or more edentulous sites that exhibit adequate natural bone and sufficient keratinized tissue
4. Demonstrated willingness to undergo study treatment and to comply with study timeline -

Exclusion Criteria:

1. Full edentulism
2. Any chronic health condition or medication that in the opinion of the investigators may adversely affect bone healing

3. Any indication of an inability to make autonomous decisions

   -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser-ablated dental implant-abutments; Laser-ablated dental implant abutments will be attached to surgically placed dental implants.	Device: Dental implant-abutments; At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16. Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16. The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration.; Other Names: BioHorizons' Laser-Lok® abutment; BioHorizons' smooth-surfaced abutment
Active Comparator: Smooth implant-abutments; Smooth dental implant-abutments will be attached to surgically placed dental implants.	Device: Dental implant-abutments; At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16. Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16. The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration.; Other Names: BioHorizons' Laser-Lok® abutment; BioHorizons' smooth-surfaced abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number od Participants With Consistent Connective Tissue Integration at a Histologic Level	Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.	8 weeks post-abutment placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grams of Force Needed to Disrupt Tissue Attachment to the Abutment	A force transducing periodontal probe instrument will electronically capture the grams of force needed to disrupt the attachment to the implant abutment; tissues will be probed from the gingival margin to the alveolar bone crest at 4 points around each abutment and an adjacent tooth: measurements will be captured from the mesial, buccal, distal, and lingual. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.	8 weeks post-abutment placement
Mean Change in Millimeters of Clinical Attachment to the Abutment	A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.	8 weeks post-abutment placement
Mean Change in Millimeters of Clinical Attachment to the Abutment	A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.	12 weeks post-abutment placement
Mean Change in Millimeters of Clinical Attachment to the Abutment	A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.	16 weeks post-abutment placement
Mean Change in Millimeters of Clinical Attachment to the Abutment	A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.	12 month post-abutment placement

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: BioHorizons, Inc.

Publications and helpful links

General Publications

• Geurs NC, Geisinger ML, Vassilopoulos PJ, O'Neal SJ, Haigh SJ, Reddy MS. Optimizing Connective Tissue Integration on Laser-Ablated Implant Abutments. Clin Adv Periodontics. 2016 Aug;6(3):153-159. doi: 10.1902/cap.2016.150068.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 27, 2013
• First Submitted That Met QC Criteria: March 27, 2013
• First Posted (Estimate): April 2, 2013

Study Record Updates

• Last Update Posted (Estimate): January 25, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Dental Implants; Implant abutments
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: Bio-LL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED