Trial Outcomes & Findings for Implant Survival After Insertion of Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting (NCT NCT02699866)

Results Overview

A "surviving implant" is an implant stably inserted in the subject's jaw bone at the time of assessment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

12 months after implant placement

Results posted on

2021-08-31

Participant Flow

First site was initiated on 11th DEC 2015 (Mainz University). The first patient was included on 12 FEB 2016 and the last patient out was on 07 JUN 2019 (last 1-year follow-up). The last centre was closed on 10 DEC 2019 (Münster).

This was a non-randomized study (N/A).

Participant milestones

Participant milestones
Measure	BLT Implant Ø 2.9 mm The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm. BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Overall Study STARTED	46
Overall Study Included	41
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	BLT Implant Ø 2.9 mm The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm. BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	2
Overall Study Adverse Event	3

Baseline Characteristics

Implant Survival After Insertion of Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BLT Implant Ø 2.9 mm n=41 Participants The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm. BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Age, Continuous	44.53 years STANDARD_DEVIATION 18.31 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Germany	41 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after implant placement

A "surviving implant" is an implant stably inserted in the subject's jaw bone at the time of assessment.

Outcome measures

Outcome measures
Measure	BLT Implant Ø 2.9 mm n=41 Participants The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm. BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Implant Survival Rate at 12 Months After Implant Placement	92.68 percentage of participants Interval 79.0 to 97.58

SECONDARY outcome

Timeframe: 6 months after implant placement

Population: 11 missing values.

The Pink esthetic score allows an objective evaluation of peri-implant soft tissue of single tooth implants based on 7 variables and is highly reproducible. Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, and 2 being the highest value. The minimum achievable PES is 0 and the maximum score is 14. The higher the value, the better the outcome.

Outcome measures

Outcome measures
Measure	BLT Implant Ø 2.9 mm n=30 Participants The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm. BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Pink Esthetic Score (PES) at 6 Months After Implant Placement	11.2 score on a scale Interval 10.5 to 11.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months after implant placement

Population: 2 missing values.

A "successful implant" is an implant where all of the following success criteria (according to Buser et al., 1992) apply: 1. Absence of persisting subjective discomfort such as pain, foreign body perception and/or dysesthesia (painful sensation); 2. Absence of recurrent peri-implant infection with suppuration; 3. Absence of tactile implant mobility; 4. Absence of a continuous peri-implant radiolucency.

Outcome measures

Outcome measures
Measure	BLT Implant Ø 2.9 mm n=39 Participants The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm. BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Implant Success Rate at 12 Months After Implant Placement	89.7 percentage of participants Interval 75.8 to 97.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 months after implant placement

An independent expert is contracted to perform the bone level measurements from the X-rays. The vertical bone level is evaluated by measuring the distance from the implant shoulder to the first visible bone contact on the implant. Measurements are taken at the mesial and distal aspects of the implant, and an average value is calculated. Mean bone level changes are computed by subtracting the average bone level at 12 months after implant placement from the average bone level at baseline (implant placement). Hence, negative bone level changes are representing bone loss; vice versa positive changes representing bone gain. Measurements take into account distortion based on changes on the radiograph from the true dimension of the implant.

Outcome measures

Outcome measures
Measure	BLT Implant Ø 2.9 mm n=34 Participants The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm. BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Marginal Bone Level Changes at 12 Months After Implant Placement	-0.3 mm Interval -0.4 to -0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, Baseline, 7-14 days after implant placement, 6 weeks after implant placement, 4 months after implant placement, 6 months after implant placement and 12 months after implant placement

At each visit the Investigator should determine if any adverse events occurred since the last study visit by speaking with the patient and reviewing any dental and medical records. These AEs, along with any AEs from the current study visit, should be documented and reported as described in Section 8 of the protocol. In addition the Investigator should evaluate the status of any ongoing AEs throughout the study.

Outcome measures

Outcome measures
Measure	BLT Implant Ø 2.9 mm n=41 Participants The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm. BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Incidence of Adverse Events and Adverse Device Effects Adverse Events (AE)	10 Participants
Incidence of Adverse Events and Adverse Device Effects Adverse Device Effects (ADE)	6 Participants
Incidence of Adverse Events and Adverse Device Effects Serious Adverse Events	0 Participants
Incidence of Adverse Events and Adverse Device Effects Serious Adverse Device Effects	0 Participants
Incidence of Adverse Events and Adverse Device Effects Unanticipated Serious Adv. Device Effect (USADE)	0 Participants
Incidence of Adverse Events and Adverse Device Effects No AEs	25 Participants

Adverse Events

BLT Implant Ø 2.9 mm

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BLT Implant Ø 2.9 mm n=41 participants at risk The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm. BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Surgical and medical procedures Implant lost	7.3% 3/41 • Number of events 3 • 1 year Adverse Events were recorded at every patient visit and monitored during IMV. Safety Board meetings were conducted to assess the reported and monitored AEs from a Sponsor-Perspective.
Respiratory, thoracic and mediastinal disorders Common cold	4.9% 2/41 • Number of events 2 • 1 year Adverse Events were recorded at every patient visit and monitored during IMV. Safety Board meetings were conducted to assess the reported and monitored AEs from a Sponsor-Perspective.
General disorders Inflammation	7.3% 3/41 • Number of events 3 • 1 year Adverse Events were recorded at every patient visit and monitored during IMV. Safety Board meetings were conducted to assess the reported and monitored AEs from a Sponsor-Perspective.
Gastrointestinal disorders Diarrhea	4.9% 2/41 • Number of events 2 • 1 year Adverse Events were recorded at every patient visit and monitored during IMV. Safety Board meetings were conducted to assess the reported and monitored AEs from a Sponsor-Perspective.

Additional Information

Dr. Michael McCaskey, Team Leader Clinical Research

Institut Straumann AG

Phone: +41619651741

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60