Trial Outcomes & Findings for The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels (NCT NCT04043286)

Results Overview

Standardized digital periapical radiographs were taken at baseline (implant placement) and at the 1-year follow-up using the long-cone paralleling technique with a custom jig. Peri-implant marginal bone levels were measured on both the mesial and distal aspects to assess bone loss. Changes in peri-implant marginal bone levels were calculated by comparing the measurements at the 1-year follow-up to the baseline values.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

At baseline (implant placement) and 1 year follow up

Results posted on

2024-12-04

Participant Flow

1. Read, sign, and receive a copy of the consent form. 2. Male or female, at least 18 years old, with good oral and general health. 3. Healed edentulous site with two or more missing teeth in the posterior maxilla or mandible (excluding third molars). 4. Adequate bone width and height for a 4.3 mm diameter, 8 mm length implant. 5. Have at least 8 mm restorative space. 6. Willing to participate and attend a 1-year follow-up before implant restoration procedures.

19 participants were initially enrolled. 2 participants withdrew: one moved away during the COVID-19 pandemic, and another agreed to participate and signed the consent form but later withdrew due to being unable to attend the scheduled surgery.

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	Control Group Control group: Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnections and reconnections during 1 year follow-up before implant restoration procedures.	Test Group Test group: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during 1 year follow-up before implant restoration procedures.
Overall Study STARTED	19 20	19 20
Overall Study COMPLETED	17 19	17 19
Overall Study NOT COMPLETED	2 1	2 1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Control group: Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnections and reconnections during 1 year follow-up before implant restoration procedures.	Test Group Test group: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during 1 year follow-up before implant restoration procedures.
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Split Mouth Subject n=38 Implants Control group: Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the prosthetic phase Test group: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase Definitive abutment: With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures
Age, Continuous	64 years STANDARD_DEVIATION 12 • n=17 Participants
Sex: Female, Male Female	9 Participants n=17 Participants
Sex: Female, Male Male	8 Participants n=17 Participants
Region of Enrollment United States	17 participants n=17 Participants

PRIMARY outcome

Timeframe: At baseline (implant placement) and 1 year follow up

Standardized digital periapical radiographs were taken at baseline (implant placement) and at the 1-year follow-up using the long-cone paralleling technique with a custom jig. Peri-implant marginal bone levels were measured on both the mesial and distal aspects to assess bone loss. Changes in peri-implant marginal bone levels were calculated by comparing the measurements at the 1-year follow-up to the baseline values.

Outcome measures

Outcome measures
Measure	Control Group n=19 Implants Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the prosthetic phase	Test Group n=19 Implants Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase Definitive abutment: With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures
Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up	0.80 millimeters Standard Deviation 0.92	0.32 millimeters Standard Deviation 0.47

SECONDARY outcome

Timeframe: At baseline (implant placement) and 1 year follow up

The width of the keratinized mucosa was measured at the mid-buccal aspect of the abutments using a periodontal probe with 1.0 mm markings. Measurements were repeated at the 1-year follow-up at the same location and compared to the baseline values.

Outcome measures

Outcome measures
Measure	Control Group n=19 Implants Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the prosthetic phase	Test Group n=19 Implants Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase Definitive abutment: With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures
Changes in Keratinized Mucosa Width	0.90 millimeters Standard Deviation 0.77	0.42 millimeters Standard Deviation 0.42

SECONDARY outcome

Timeframe: At baseline (implant placement) and 1 year follow up

The thickness of the lingual mucosa at each implant site was measured at the center of the implant site from the bone crest using a periodontal probe with 1.0 mm markings. Measurements were repeated at the 1-year follow-up at the same location and compared to the baseline values taken on the day of implant surgery.

Outcome measures

Outcome measures
Measure	Control Group n=19 Implants Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the prosthetic phase	Test Group n=19 Implants Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase Definitive abutment: With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures
Changes in Lingual Mucosa Thickness	0.71 millimeters Standard Deviation 0.59	0.38 millimeters Standard Deviation 0.26

SECONDARY outcome

Timeframe: 12 months after surgical implantation

Success was determined by the implant's ability to meet these clinical factors, such as the absence of pain, infection, mobility, and radiographic bone loss beyond the acceptable threshold of the follow-up period, as assessed at 12 months post-surgical implantation.

Outcome measures

Outcome measures
Measure	Control Group n=19 Implants Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the prosthetic phase	Test Group n=19 Implants Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase Definitive abutment: With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures
Implant Success Rate According to the 2017 Classification Criteria Set by the American Academy of Periodontology (AAP)	0 Implants	0 Implants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Group

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

Dr. Sasiya Bhumpattarachai

Loma Linda University, School of Dentistry

Phone: 6267565156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place