Effect of Implant Thread Design on Implant Stability Quotient (ISQ) in Early Healing Period

NCT02701387 | Completed Results

• 1 other identifier: UCLA Megagen AnyRidge ISQ
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether implant thread design impacts bone remodeling and/or dental implant stability in the early healing period. The population of this study will consist of a group of subjects who are interested in replacing two or more missing teeth with dental implants. All implant sites will be healed and not require bone augmentation for the placement of a standard 4 mm diameter implant. Subjects first will undergo a brief screening exam. If accepted, comprehensive oral exam will be completed. Subsequently, enrolled subjects will be scheduled for dental surgery to place the implant(s). Subjects will return weekly for the first 8 weeks after placement for a brief post-operative appointment in order to conduct measurements for the study.

Conditions

Partial Edentulism

Keywords

bone implant interaction; implant stability; resonance frequency analysis (RFA); implant stability quotient (ISQ)

Outcome Measures

Primary Outcomes (1)

• Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone

  Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows: Tr0 = T0 (baseline) Tr1 = Average of follow-up week 1 (T1) and follow-up week 2 (T2) Tr2 = Average of follow-up week 3 (T3) and follow-up week 4 (T4) Tr3 = Average of follow-up week 5 (T5) and follow-up week 6 (T6) Tr4 = Average of follow-up week 7 (T7) and follow-up week 8 (T8)

  Baseline (T0) and weekly thereafter for 8 weeks (T1-T8)

Study Arms (2)

AnyRidge Implant

EXPERIMENTAL

Experimental implant (Megagen AnyRidge dental implant) placed in a healed edentulous site to replace a missing tooth.

Device: Megagen AnyRidge dental implant

EZ Plus Implant

ACTIVE COMPARATOR

Comparative implant (Megagen EZ Plus dental implant) placed in a healed edentulous site to replace a missing tooth.

Device: Megagen EZ Plus dental implant

Interventions

Megagen AnyRidge dental implant DEVICE

AnyRidge is an approved dental implant with a knife edge, thin thread design available in various thread widths (depth).

AnyRidge Implant

Megagen EZ Plus dental implant DEVICE

EZ Plus is an approved dental implant with a standard thread design (width and depth) and that is comparable to many other dental implants currently available on the market.

EZ Plus Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Missing two or more teeth with a desire to receive an implant-supported or implant-assisted tooth replacement
• Healed maxillary or mandibular edentulous site for implant placement
• Sufficient bone volume in the site to allow implant placement without the need for bone augmentation

You may not qualify if:

• Systemic disease, medication, or habit known to negatively influence bone healing and/or dental implant success
• Poorly controlled diabetes (HbA1c \> 8%)
• History of bisphosphonate use
• History of head \& neck radiation therapy affecting the proposed implant site
• History of smoking \>10 cigarettes/day (within past 12 months)
• Current use of medications that adversely affect healing (e.g. corticosteroids, chemotherapeutic drugs)
• Immune compromised condition (resulting from disease or treatment)
• Insufficient bone volume for dental implant placement
• Otherwise contraindicated to undergo periodontal / oral / implant surgery

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Perry R. Klokkevold, DDS, MS, FACD
• Organization: UCLA School of Dentistry

pklokkevold@dentistry.ucla.edu

310-825-1927

Study Officials

• Perry R Klokkevold, DDS, MS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 8, 2016
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 29, 2016
• Results First Posted: December 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share