Trial Outcomes & Findings for Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface (NCT NCT00782171)

NCT ID: NCT00782171

Last Updated: 2017-06-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 266 participants
• Primary outcome timeframe: Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery
• Results posted on: 2017-06-20

Participant Flow

From the 280 patients (146/134 immediate/early loading group) who received a study implant 266 patients (138/128 immediate/early loading group) fulfilled all primary and secondary inclusion/exclusion criteria after Implantation. The main effectiveness analysis was performed on this population

Participant milestones

Measure	Immediate Loading Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Overall Study STARTED	146	134
Overall Study 20-23 Weeks	135	124
Overall Study 1 Year	131	120
Overall Study Surgery (Baseline)	138	128
Overall Study COMPLETED	124	115
Overall Study NOT COMPLETED	22	19

Reasons for withdrawal

Measure	Immediate Loading Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	2	1
Overall Study complications	3	1
Overall Study others	7	9
Overall Study not eligible	8	6

Baseline Characteristics

Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface

Baseline characteristics by cohort

Measure	Immediate Loading n=138 Participants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=128 Participants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant	Total n=266 Participants Total of all reporting groups
Age, Continuous	46.1 years STANDARD_DEVIATION 13.3 • n=5 Participants	46.6 years STANDARD_DEVIATION 12.4 • n=7 Participants	46.3 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	74 Participants n=7 Participants	148 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	54 Participants n=7 Participants	118 Participants n=5 Participants
implant distribution maxilla, mandible patients with implants in the maxilla	47 participants n=5 Participants	37 participants n=7 Participants	84 participants n=5 Participants
implant distribution maxilla, mandible patients with implants in the mandible	72 participants n=5 Participants	79 participants n=7 Participants	151 participants n=5 Participants
implant distribution maxilla, mandible patients with implants in both jaws	19 participants n=5 Participants	12 participants n=7 Participants	31 participants n=5 Participants
Number of implants placed	197 implants n=5 Participants	186 implants n=7 Participants	383 implants n=5 Participants

PRIMARY outcome

Timeframe: Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery

Population: This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.

Outcome measures

Measure	Immediate Loading n=169 Implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=152 Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.	0.82 mm Standard Deviation 0.89	0.56 mm Standard Deviation 0.73

PRIMARY outcome

Timeframe: Change in crestal bone level from surgery (baseline) to 1 year post-surgery

Population: This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.

Outcome measures

Measure	Immediate Loading n=168 Implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=155 Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.	0.90 mm Standard Deviation 0.90	0.59 mm Standard Deviation 0.79

PRIMARY outcome

Timeframe: Change in crestal bone level from surgery (baseline) to 2 years post-surgery

Population: This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.

Outcome measures

Measure	Immediate Loading n=157 Implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=149 Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.	0.89 mm Standard Deviation 0.90	0.57 mm Standard Deviation 0.83

PRIMARY outcome

Timeframe: Change in crestal bone level from surgery (baseline) to 3 years post-surgery

Population: This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.

Outcome measures

Measure	Immediate Loading n=155 Implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=140 Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.	0.88 mm Standard Deviation 0.82	0.57 mm Standard Deviation 0.84

SECONDARY outcome

Timeframe: 20-23 Weeks post-surgery

Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation

Outcome measures

Measure	Immediate Loading n=197 Implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=186 Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Implant Survival	193 implants	180 implants

SECONDARY outcome

Timeframe: 1 year post-surgery

Population: Number of implants placed. Implants from drop-outs are not included

Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation

Outcome measures

Measure	Immediate Loading n=197 Number of implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=186 Number of implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Implant Survival	193 implants	180 implants

SECONDARY outcome

Timeframe: 2 years post-surgery

Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation

Outcome measures

Measure	Immediate Loading n=197 Number of Implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=186 Number of Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Implant Survival	192 implants	180 implants

SECONDARY outcome

Timeframe: 3 years post-surgery

Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation

Outcome measures

Measure	Immediate Loading n=197 Number of Implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=186 Number of Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Implant Survival	192 implants	180 implants

SECONDARY outcome

Timeframe: until the 3 year post-surgery

Population: All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled

Patients affected by AE Patients affected by related/ unknown AE

Outcome measures

Measure	Immediate Loading n=146 Participants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=134 Participants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected Patients affected by AE	38 patients affected	35 patients affected
Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected Patients affected by related/ unknown AE	20 patients affected	15 patients affected

SECONDARY outcome

Timeframe: 20-23 weeks post-surgery

Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant

Outcome measures

Measure	Immediate Loading n=135 Participants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=180 Number of Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Implant Success	187 implants	174 implants

SECONDARY outcome

Timeframe: 1 years post-surgery

Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant

Outcome measures

Measure	Immediate Loading n=190 Number of Implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=178 Number of Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Implant Success	185 implants	172 implants

SECONDARY outcome

Timeframe: 2 years post-surgery

Population: The analysis was based on implants as observational unit. The 2-year data was analyzed together with the 3-year data. Our statistical analysis for 2-year time point included how many implants were available but not how many participants.

Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant

Outcome measures

Measure	Immediate Loading n=183 Number of Implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=172 Number of Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Implant Success	177 implants	164 implants

SECONDARY outcome

Timeframe: 3 years post-surgery

Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant

Outcome measures

Measure	Immediate Loading n=180 Number of Implants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=170 Number of Implants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Implant Success	174 implants	164 implants

SECONDARY outcome

Timeframe: until the 3 year post-surgery

Population: All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled

Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs)

Outcome measures

Measure	Immediate Loading n=146 Participants Implant(s) will be restored with a temporary restoration on the day of surgery SLActive dental implant	Early Loading n=134 Participants Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery SLActive dental implant
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events Number of Adverse Events	56 number of events	41 number of events
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events Number of related/unknown AEs	26 number of events	17 number of events
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events Number of related/unknown SAEs	0 number of events	0 number of events
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events Number of Serious Adverse Events	3 number of events	1 number of events

Adverse Events

Immediate Loading

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Early Loading

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Immediate Loading n=146 participants at risk SLActive Implant(s) will be restored with a temporary restoration on the day of surgery.	Early Loading n=134 participants at risk Healing caps will be placed on the SLActive Implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
Eye disorders CORNEAL ULCER	0.68% 1/146 • Number of events 2 • 3 years	0.00% 0/134 • 3 years
Gastrointestinal disorders stomach canser	0.68% 1/146 • Number of events 1 • 3 years	0.00% 0/134 • 3 years
Infections and infestations PERI - IMPLANT INFECTION	0.00% 0/146 • 3 years	0.75% 1/134 • Number of events 1 • 3 years

Other adverse events

Measure	Immediate Loading n=146 participants at risk SLActive Implant(s) will be restored with a temporary restoration on the day of surgery.	Early Loading n=134 participants at risk Healing caps will be placed on the SLActive Implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
Surgical and medical procedures Prosthetic related complication	8.9% 13/146 • Number of events 16 • 3 years	9.0% 12/134 • Number of events 15 • 3 years
General disorders Pain, discomfort	4.8% 7/146 • Number of events 9 • 3 years	0.00% 0/134 • 3 years

Additional Information

Institut Straumann AG

Institut Straumann AG - Clinical Research

Phone: +41 61 965 11 11

Email: research@straumann.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place