| |
|
Objective Report
for Third Molar Clinical Trial
Protocol 95-00067
October 12, 2004 |
| |
| OBJECTIVE of the study: |
|
Every young
adult in the United States must make the decision regarding
the future of their third molars. Almost no reliable
scientific data exists for professionals to assist patients in
this decision. The likelihood of problems with third
molar are endemic lading to almost universal recommendation of
"preventive" extractions. |
| |
| The research objectives
are: |
| 1. compares within
each patient the clinical/biological ad health-related quality
of life (HRQOL) outcomes of removal versus retention of third
molars. |
| |
| 2. compares across
patient groups the clinical/biological and HRQOL outcomes of
removal versus retention of third molars. |
| |
| RESEARCH PLAN of the
study: |
| • Completing
enrollment of up to 250 qualifying patients in conjunction
with University of North Carolina.
• Stratification factors on
enrolled patients include age range of 14-45, gender, and
race.
• Demographics and
Attitudinal components are also monitored. |
| |
| METHODOLOGY of the
study: |
|
Each eligible
patient who has agreed to participate and who has met
inclusion and exclusion criteria will be managed according to
a prescribed schedule. Baseline data is collected and
participants will be monitored for five years. The
annual monitoring appointments would include a dental
prophylaxis provided by the study registered dental hygienist.
Sampling includes:
|
• crevicular fluids,
plaque samples and periodontal probing depths;
|
• 2 vertical
bitewings, panorex
|
• updating patient
data followed by quarterly telephone surveys complete the
appointment.
|
| • problem are
addressed if occurring during the interim. |
| |
|
The morbidity
associated with third molar removal is compared to third molar
retention. The statistical analysis evaluates
periodontal health, patient perception, frequency of
complications, and risk model development. |
| |
| FINDINGS of the study: |
| To be determined at the
end of the study. |
