Trial Outcomes & Findings for A Study of Dental Implants Coated With Bone Morphogenetic Protein (NCT NCT00422279)

Results Overview

The following success criteria for the primary endpoint have been adopted and apply to both treatment groups. 1.The implant stability (ISQ) was recorded by means of resonance frequency analysis (RFA) at implant insertion, 3 months and after 6 months of loading 2. radiographic and computed tomography analyses shall not show any signs of peri-implant radiolucency at the 3 and 6 month time point 3. implant stability after 3 months shall allow tightening to 35Ncm without implant rotation by using a torque wrench

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Implant insertion, 3 months, 6 months

Results posted on

2016-04-20

Participant Flow

Four patients have been recruited to participate in this study after they met the inclusion criteria, all patients have been recruited at the Medical college of Georgia, Augusta, GA, USA

all the four study patients met the inclusion criteria no run in's have been encountered, all the patients completed this study at the scheduled follow up visits

Participant milestones

Participant milestones
Measure	Supraalveolar Position bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position	Extraction Sites bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
Overall Study STARTED	2	2
Overall Study 24 Month After Loading Period	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Dental Implants Coated With Bone Morphogenetic Protein

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supralveolar Position n=2 Participants bone inductive implants placed in supraalveolar position	Extraction Sites n=2 Participants bone inductive implants placed in tooth extraction sites	Total n=4 Participants Total of all reporting groups
Region of Enrollment United States	2 participants n=93 Participants	2 participants n=4 Participants	4 participants n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Implant insertion, 3 months, 6 months

Population: Implant stability was measured using a torque wrench, Resonance frequency analysis was conducted, radiographs were analyzed and computed tomography was performed

The following success criteria for the primary endpoint have been adopted and apply to both treatment groups. 1.The implant stability (ISQ) was recorded by means of resonance frequency analysis (RFA) at implant insertion, 3 months and after 6 months of loading 2. radiographic and computed tomography analyses shall not show any signs of peri-implant radiolucency at the 3 and 6 month time point 3. implant stability after 3 months shall allow tightening to 35Ncm without implant rotation by using a torque wrench

Outcome measures

Outcome measures
Measure	Supra Aleveolar Position n=4 Implants bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position	Extraction Sites n=4 Implants bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading Stability Baseline	4 implants	4 implants
Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading Stability 3 months submerged healing	4 implants	3 implants
Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading Stability 6 months Prosthetic loading	4 implants	3 implants

SECONDARY outcome

Timeframe: 3 months

Population: 1.When implants were placed in the supraalveolar position the treatment was not successful 2. in the group where implants were placed in extraction sockets the treatment was not successful

The secondary endpoint of the study was to assess the minimum dose of rhBMP2 eliciting bone growth.The secondary endpoint was assessed by measuring using a probe the quantity of any newly formed bone 1.in the group where implants were placed in the supra alveolar position the treatment is successful if the bone exceeds 1.5 mm above the initial alveolar bone level in all measured points 1. in the group where implants were placed in extraction sockets the treatment is successful if the gap between the implant body and the extraction socket is filled with Bone. Safety dose used:- In the dog model; seroma formation was extensive with higher rhBMP-2 concentrations (3.0 and 4.0 mg/mL.Seromas was also significant in the dog model for the 0.75 and 1.5 mg/mL rhBMP-2 concentrations, hence a minimum dose of 15 and 30 µg per implants was chosen)

Outcome measures

Outcome measures
Measure	Supra Aleveolar Position n=2 Participants bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position	Extraction Sites n=2 Participants bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant)	0 Number of participants with bone grow	0 Number of participants with bone grow

Adverse Events

Supralveolar Position

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Extraction Sites

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Supralveolar Position n=2 participants at risk bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position	Extraction Sites n=2 participants at risk bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sites
Endocrine disorders Hyperthyroidism	0.00% 0/2	50.0% 1/2 • Number of events 1
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/2	50.0% 1/2 • Number of events 1

Additional Information

Isabelle Arrighi, Head Clinical Trial Management

Nobel Biocare

Phone: +41 43 211 42 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee I understand that I retain the right to publish the data from the clinical work that I perform. I agree that Nobel Biocare USA, LLC will be allowed to review and comment on such a document prior to its publication to ensure that the document does not disclose any trade secrets or other confidential information which may be known to me by virtue of my participation in the clinical study. I will not disclose any information regarding the study without permission from Nobel Biocare USA, LLC.
Publication restrictions are in place

Restriction type: OTHER