Trial Outcomes & Findings for Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla (NCT NCT00906425)
NCT ID: NCT00906425
Last Updated: 2016-03-30
Results Overview
The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
145 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2016-03-30
Participant Flow
Participant milestones
| Measure |
Submerged Healing
The dental implants will be placed using a submerged healing treatment
|
Trans-mucosal Healing
The dental implants will be placed using a trans-mucosal healing treatment
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
72
|
|
Overall Study
6 Months
|
69
|
64
|
|
Overall Study
1 Year
|
67
|
60
|
|
Overall Study
2 Year
|
62
|
58
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
73
|
72
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla
Baseline characteristics by cohort
| Measure |
Submerged Healing
n=73 Participants
The dental implants will be placed using a submerged healing treatment
|
Trans-mucosal Healing
n=72 Participants
The dental implants will be placed using a trans-mucosal healing treatment
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
19 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: ITT population
The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.
Outcome measures
| Measure |
Submerged Healing
n=65 Participants
The dental implants will be placed using a submerged healing treatment
|
Trans-mucosal Healing
n=59 Participants
The dental implants will be placed using a trans-mucosal healing treatment
|
|---|---|---|
|
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)
|
-0.32 millimeters
Standard Deviation 0.47
|
-0.29 millimeters
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 6 monthsThe percentage of implants that remain in place in the jaw.
Outcome measures
| Measure |
Submerged Healing
n=67 Participants
The dental implants will be placed using a submerged healing treatment
|
Trans-mucosal Healing
n=60 Participants
The dental implants will be placed using a trans-mucosal healing treatment
|
|---|---|---|
|
Implant Survival Rate
|
100 % of implants
|
98.3 % of implants
|
SECONDARY outcome
Timeframe: 12 monthsThe percentage of implants that remain in place in the jaw.
Outcome measures
| Measure |
Submerged Healing
n=67 Participants
The dental implants will be placed using a submerged healing treatment
|
Trans-mucosal Healing
n=60 Participants
The dental implants will be placed using a trans-mucosal healing treatment
|
|---|---|---|
|
Implant Survival Rate
|
100 % of implants
|
98.3 % of implants
|
Adverse Events
Submerged Healing
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Trans-mucosal Healing
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Submerged Healing
n=73 participants at risk
The dental implants will be placed using a submerged healing treatment
|
Trans-mucosal Healing
n=72 participants at risk
The dental implants will be placed using a trans-mucosal healing treatment
|
|---|---|---|
|
Reproductive system and breast disorders
Uterine Cancer
|
1.4%
1/73 • Number of events 1 • 6 Months
|
0.00%
0/72 • 6 Months
|
|
General disorders
|
1.4%
1/73 • Number of events 1 • 6 Months
|
0.00%
0/72 • 6 Months
|
Other adverse events
| Measure |
Submerged Healing
n=73 participants at risk
The dental implants will be placed using a submerged healing treatment
|
Trans-mucosal Healing
n=72 participants at risk
The dental implants will be placed using a trans-mucosal healing treatment
|
|---|---|---|
|
General disorders
Implant or site related complications
|
1.4%
1/73 • Number of events 1 • 6 Months
|
0.00%
0/72 • 6 Months
|
|
General disorders
Implant mobility
|
0.00%
0/73 • 6 Months
|
1.4%
1/72 • Number of events 1 • 6 Months
|
|
General disorders
Dehiscence at implant site
|
0.00%
0/73 • 6 Months
|
1.4%
1/72 • Number of events 1 • 6 Months
|
|
General disorders
Gingival/Mucosal Problems
|
1.4%
1/73 • Number of events 1 • 6 Months
|
0.00%
0/72 • 6 Months
|
|
General disorders
Fistula
|
1.4%
1/73 • Number of events 1 • 6 Months
|
1.4%
1/72 • Number of events 1 • 6 Months
|
|
General disorders
Prosthetic Related Complications
|
1.4%
1/73 • Number of events 1 • 6 Months
|
2.8%
2/72 • Number of events 2 • 6 Months
|
|
General disorders
Lost/Failure (fracture) of an Abutment
|
0.00%
0/73 • 6 Months
|
1.4%
1/72 • Number of events 1 • 6 Months
|
|
General disorders
Loosening of Occlusal Screw
|
0.00%
0/73 • 6 Months
|
1.4%
1/72 • Number of events 1 • 6 Months
|
|
General disorders
Aesthetic Problems
|
0.00%
0/73 • 6 Months
|
1.4%
1/72 • Number of events 1 • 6 Months
|
|
General disorders
Failure of Prosthetic Part (framework)
|
1.4%
1/73 • Number of events 1 • 6 Months
|
0.00%
0/72 • 6 Months
|
|
General disorders
Acrylic or Porcelain Fractures
|
0.00%
0/73 • 6 Months
|
2.8%
2/72 • Number of events 2 • 6 Months
|
|
Reproductive system and breast disorders
Uterine Cancer
|
1.4%
1/73 • Number of events 1 • 6 Months
|
0.00%
0/72 • 6 Months
|
|
General disorders
Local discomfort/pain around the implant site
|
0.00%
0/73 • 6 Months
|
1.4%
1/72 • Number of events 1 • 6 Months
|
|
General disorders
Allergic reaction
|
1.4%
1/73 • Number of events 1 • 6 Months
|
0.00%
0/72 • 6 Months
|
|
General disorders
Membrane Exposure
|
0.00%
0/73 • 6 Months
|
2.8%
2/72 • Number of events 2 • 6 Months
|
|
Endocrine disorders
Hyperthyreosis
|
1.4%
1/73 • Number of events 1 • 6 Months
|
0.00%
0/72 • 6 Months
|
|
General disorders
|
1.4%
1/73 • Number of events 1 • 6 Months
|
0.00%
0/72 • 6 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60