Effect of Implant Thread Design on Implant Stability Quotient (ISQ) in Early Healing Period (NCT02701387) | Clinical Trial Compass
CompletedNot Applicable
Effect of Implant Thread Design on Implant Stability Quotient (ISQ) in Early Healing Period
7 participantsStarted 2014-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone
Timeframe: Baseline (T0) and weekly thereafter for 8 weeks (T1-T8)