Trial Outcomes & Findings for A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing (NCT NCT01822223)

NCT ID: NCT01822223

Last Updated: 2017-01-25

Results Overview

Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 8 weeks post-abutment placement
• Results posted on: 2017-01-25

Participant Flow

Participant milestones

Measure	Laser-ablated Dental Implant-abutments Laser-ablated dental implant abutments will be attached to surgically placed dental implants.	Smooth Implant-abutments Smooth dental implant-abutments will be attached to surgically placed dental implants.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Laser-ablated Dental Implant-abutments Laser-ablated dental implant abutments will be attached to surgically placed dental implants.	Smooth Implant-abutments Smooth dental implant-abutments will be attached to surgically placed dental implants.
Overall Study Death	0	1

Baseline Characteristics

A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing

Baseline characteristics by cohort

Measure	Laser-ablated Dental Implant-abutments n=10 Participants Laser-ablated dental implant abutments will be attached to surgically placed dental implants. Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a \& 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16. Sub-groups 1-b \& 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16. The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration.	Smooth Implant-abutments n=10 Participants Smooth dental implant-abutments will be attached to surgically placed dental implants. Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a \& 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16. Sub-groups 1-b \& 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16. The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Gender Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks post-abutment placement

Population: The number of participants entered represents measured data.

Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.

Outcome measures

Measure	Laser-ablated Dental Implant-abutments n=10 Participants Laser-ablated dental implant abutments will be attached to surgically placed dental implants. Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a \& 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16. Sub-groups 1-b \& 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16. The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration.	Smooth Implant-abutments n=10 Participants Smooth dental implant-abutments will be attached to surgically placed dental implants. Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a \& 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16. Sub-groups 1-b \& 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16. The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration.
Number od Participants With Consistent Connective Tissue Integration at a Histologic Level	10 participants	10 participants

SECONDARY outcome

Timeframe: 8 weeks post-abutment placement

Population: No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.

A force transducing periodontal probe instrument will electronically capture the grams of force needed to disrupt the attachment to the implant abutment; tissues will be probed from the gingival margin to the alveolar bone crest at 4 points around each abutment and an adjacent tooth: measurements will be captured from the mesial, buccal, distal, and lingual. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks post-abutment placement

Population: No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.

A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks post-abutment placement

Population: No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.

A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks post-abutment placement

Population: No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.

A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month post-abutment placement

Population: No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.

A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.

Outcome measures

Outcome data not reported

Adverse Events

Laser-ablated Dental Implant-abutments

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smooth Implant-abutments

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

Michael S. Reddy, DMD, DMSc

University of Alabama at Birmingham

Phone: 2059344720

Email: mreddy@uab.edu

Results disclosure agreements

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