Assessment of Integration Success of an Implant System With a Novel Abutment Attachment Design in Early Loaded Cases

A Prospective Randomized-controlled Study of the Integration Success Rate of an Implant System With a Novel Abutment Attachment in Cases Loaded Early

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529814

Acronym

Comet

Enrollment

Registered

2012-02-09

Start date

2011-07-31

Completion date

2016-12-31

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Edentulism, Tooth Disease

Keywords

edentulism, dental implants, clinical study, Nanotite Certain Tapered implant, randomized, crestal bone level, early loading

Brief summary

Integration success rates measured by resistance to countertorque testing will be higher for the experimental implant design than for the control implants.

Detailed description

In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by countertorque testing and cumulative success rate in cases that are loaded early

Interventions

DEVICEImplant with new abutment connection

New abutment connection implant system

DEVICENanotite Certain Tapered implant

Nanotite Certain Tapered (standard abutment connection) implant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients of either sex and older than 18 years of age * patients needing at least one dental implant to treat partial edentulism * patients physically able to tolerate surgical and restorative dental procedures * patients agreeing to all protocol visits

Exclusion criteria

* patients with infection or severe inflammation at the intended treatment sites * patients smoking greater than 10 cigarettes per day * patients with uncontrolled diabetes mellitus * patients with uncontrolled metabolic diseases * patients who received radiation treatment to the head in the past 12 months * patients needing bone grafting at the intended treatment sites * patients known to be pregnant at screening visit * patients with para-functional habits like bruxing and clenching

Design outcomes

Primary

Measure	Time frame	Description
Primary stability countertorque measures	2 months	Resistance to countertorque measures showing primary stability success of implants

Secondary

Measure	Time frame	Description
Cumulative success rate	2 years	Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026