Trial Outcomes & Findings for A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading (NCT NCT01340170)

Results Overview

Marginal Bone Level alterations will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

168 participants

Primary outcome timeframe

Implant insertion and 12 months post implant insertion

Results posted on

2024-11-15

Participant Flow

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	Standard Drilling Protocol (Group A) A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Group A + B Subjects with implants from both Group A and Group B
Overall Study STARTED	79 83	86 99	3 6
Overall Study Permanent Restoration (Start + 3 Months)	79 83	81 94	3 6
Overall Study COMPLETED	76 79	79 91	3 6
Overall Study NOT COMPLETED	3 4	7 8	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Drilling Protocol (Group A) A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Group A + B Subjects with implants from both Group A and Group B
Overall Study Lost to Follow-up	2	4	0
Overall Study Implant failure	1	3	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Drilling Protocol (Group A) n=79 Participants A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) n=86 Participants A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Group A + B n=3 Participants Subjects with implants from both Group A and Group B	Total n=168 Participants Total of all reporting groups
Age, Continuous	46.6 Years STANDARD_DEVIATION 12.6 • n=79 Participants	47.5 Years STANDARD_DEVIATION 12.3 • n=86 Participants	54.3 Years STANDARD_DEVIATION 17.7 • n=3 Participants	47.2 Years STANDARD_DEVIATION 12.5 • n=168 Participants
Sex: Female, Male Female	43 Participants n=79 Participants	44 Participants n=86 Participants	3 Participants n=3 Participants	90 Participants n=168 Participants
Sex: Female, Male Male	36 Participants n=79 Participants	42 Participants n=86 Participants	0 Participants n=3 Participants	78 Participants n=168 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Implant insertion and 12 months post implant insertion

Population: ITT subjects with MBL data available (MBL data missing for 14 implants in Group A, and from 10 implants in group B). Outcome measure 1 is analyzed on implant level only and does not contain subject level group "Group A + B".

Marginal Bone Level alterations will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.

Outcome measures

Outcome measures
Measure	Standard Drilling Protocol (Group A) n=68 Implants A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) n=84 Implants A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm
Marginal Bone Level Change	-0.25 mm Standard Deviation 0.9	-0.2 mm Standard Deviation 0.67

SECONDARY outcome

Timeframe: Implant insertion and 3 months post implant insertion

Population: ITT subjects with MBL data available (MBL data missing from 10 implants in Group A, from 9 implants in group B). Outcome measure 2 is analyzed on implant level only and does not contain subject level group "Group A + B".

Marginal Bone Level alterations will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.

Outcome measures

Outcome measures
Measure	Standard Drilling Protocol (Group A) n=76 Implants A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) n=88 Implants A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm
Marginal Bone Level Change	-0.2 mm Standard Deviation 0.62	-0.29 mm Standard Deviation 0.67

SECONDARY outcome

Timeframe: 12 months after baseline, i.e., implant insertion

Population: ITT subjects at 12 months as well as known implant failures already terminated are included in the analysis. Outcome measure 3 is analyzed on implant level only and does not contain subject level group "Group A + B".

Implant survival rate will be evaluated by both clinically and radiographically counting the number of remaining implants from implant placement to one year after loading.

Outcome measures

Outcome measures
Measure	Standard Drilling Protocol (Group A) n=84 Implants A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) n=98 Implants A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm
Implant Survival Rate Implants confirmed success	82 Implants	94 Implants
Implant Survival Rate Implants confirmed failure	2 Implants	4 Implants

SECONDARY outcome

Timeframe: At implant insertion

Population: ITT population. Outcome measure 4 is analyzed on implant level only and does not contain subject level group "Group A + B".

Evaluated clinically/manually and recorded as stable yes/no.

Outcome measures

Outcome measures
Measure	Standard Drilling Protocol (Group A) n=86 Implants A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) n=102 Implants A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm
Implant Stability Assessed Clinically/Manually Implant stability - No	0 Implants	5 Implants
Implant Stability Assessed Clinically/Manually Implant stability - Yes	86 Implants	97 Implants

SECONDARY outcome

Timeframe: At implant insertion.

Population: ITT population. Outcome measure 5 is analyzed on implant level only and does not contain subject level group "Group A + B".

The Osstell® instrument "Osstell® ISQ" will be used to measure RFA. RFA measures the frequency with which a device vibrates. By comparing resonance frequencies the stability of a dental implant can be determined as the resonance frequency changes with different stability. The Osstell® ISQ instrument translates the RFA value into an Implant Stability Quotient (ISQ) scale value. ISQ is a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro mobility, with a higher value corresponding to increased stability.

Outcome measures

Outcome measures
Measure	Standard Drilling Protocol (Group A) n=86 Implants A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) n=102 Implants A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm
Implant Stability Using Resonance Frequency Analysis (RFA) Mesio-Distal	78.6 ISQ on implant level Standard Deviation 6.2	77.5 ISQ on implant level Standard Deviation 9.6
Implant Stability Using Resonance Frequency Analysis (RFA) Bucco-Palatinal	78.8 ISQ on implant level Standard Deviation 5.9	77.7 ISQ on implant level Standard Deviation 9.4

SECONDARY outcome

Timeframe: After implant insertion

Population: ITT subjects. Outcome measure 6 is analyzed on implant level only and does not contain subject level group "Group A + B".

After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.

Outcome measures

Outcome measures
Measure	Standard Drilling Protocol (Group A) n=86 Implants A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) n=102 Implants A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm
Perception During Implant Insertion - "The Implant Was Guided Into the Prepared Osteotomy"	7.5 score on a scale Standard Deviation 2.6	7.1 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: After implant insertion

Population: ITT subjects. Outcome measure 7 is analyzed on implant level only and does not contain subject level group "Group A + B".

After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.

Outcome measures

Outcome measures
Measure	Standard Drilling Protocol (Group A) n=86 implants A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) n=102 implants A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm
Perception During Implant Insertion - "The Implant Followed the Prepared Osteotomy"	8.2 score on a scale Standard Deviation 1.6	7.6 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: After implant insertion

Population: ITT subjects. Outcome measure 8 is analyzed on implant level only and does not contain subject level group "Group A + B".

After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.

Outcome measures

Outcome measures
Measure	Standard Drilling Protocol (Group A) n=86 implants A standard drilling protocol will be used in bone quality 1 and 2 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm	Soft Bone Drilling Protocol (Group B) n=102 implants A soft bone drilling protocol will be used in bone quality 3 and 4 OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm
Perception During Implant Insertion - "The Implant Has a Good Primary Stability"	8.7 score on a scale Standard Deviation 1.3	8.1 score on a scale Standard Deviation 1.7

Adverse Events

Standard Drilling Protocol (Group A)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Soft Bone Drilling Protocol (Group B)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group A + B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager of Global Clinical Reseach

Dentsply Sirona Implants

Phone: +46313763500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place