N/A
N=7
Effect of Implant Thread Design on Implant Stability Quotient (ISQ) in Early Healing Period
Partial Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT02701387 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone — 79.6; 80.1; 79.7; 79.7 units on a scale — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Megagen AnyRidge dental implant (Device); Megagen EZ Plus dental implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone |
79.6; 80.1; 79.7; 79.7; 80.0; 79.2 | <0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02701387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.