Trial Outcomes & Findings for Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2) (NCT NCT01623739)

Results Overview

Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

3 months after crown delivery

Results posted on

2018-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Type 1 Implant Placement Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement	Type 2 Implant Placement Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. Placement of a dental implant: Type 1 implant placement Type 2 implant placement
Overall Study STARTED	19	19
Overall Study COMPLETED	17	15
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Type 1 Implant Placement n=17 Participants Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement	Type 2 Implant Placement n=15 Participants Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. Placement of a dental implant: Type 1 implant placement Type 2 implant placement	Total n=32 Participants Total of all reporting groups
Age, Continuous	52.5 years STANDARD_DEVIATION 15.6 • n=17 Participants	50.9 years STANDARD_DEVIATION 14.6 • n=15 Participants	51.8 years STANDARD_DEVIATION 14.9 • n=32 Participants
Sex: Female, Male Female	8 Participants n=17 Participants	6 Participants n=15 Participants	14 Participants n=32 Participants
Sex: Female, Male Male	9 Participants n=17 Participants	9 Participants n=15 Participants	18 Participants n=32 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	17 participants n=17 Participants	15 participants n=15 Participants	32 participants n=32 Participants

PRIMARY outcome

Timeframe: 3 months after crown delivery

Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.

Outcome measures

Outcome measures
Measure	Type 1 Implant Placement n=17 Participants Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement	Type 2 Implant Placement n=15 Participants Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. Placement of a dental implant: Type 1 implant placement Type 2 implant placement
Mid Facial Mucosal Level at Implant Site	0.54 mm Standard Deviation 0.18	0.47 mm Standard Deviation 0.31

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 36, 48, 60 months after crown delivery

The PES and WES scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10. Any score of 6 or higher out of 10 would be considered a good clinical outcome. the PES categories focus on the gum area, and the WES categories focus on the tooth. The scores for PES and WES are totaled, to give a score out of 20, with 20 being the highest possible score (best outcome). The values are totaled and a mean score of all the readings is reported.

Outcome measures

Outcome measures
Measure	Type 1 Implant Placement n=17 Participants Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement	Type 2 Implant Placement n=15 Participants Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. Placement of a dental implant: Type 1 implant placement Type 2 implant placement
PES/WES (Pink Esthetic Score, White Esthetic Score).	13.67 units on a scale Standard Error 0.61	12.51 units on a scale Standard Error 0.65

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 36, 48, 60 months after crown delivery

The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.

Outcome measures

Outcome measures
Measure	Type 1 Implant Placement n=17 Participants Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement	Type 2 Implant Placement n=15 Participants Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. Placement of a dental implant: Type 1 implant placement Type 2 implant placement
Probing Depth	3.06 mm Standard Error 0.18	2.93 mm Standard Error 0.18

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 36, 48, 60 months after crown delivery

Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported.

Outcome measures

Outcome measures
Measure	Type 1 Implant Placement n=17 Participants Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement	Type 2 Implant Placement n=15 Participants Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. Placement of a dental implant: Type 1 implant placement Type 2 implant placement
Modified Plaque Index	0.18 units on a scale Standard Error 0.10	0.27 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 36, 48, 60 months after crown delivery

Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported.

Outcome measures

Outcome measures
Measure	Type 1 Implant Placement n=17 Participants Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement	Type 2 Implant Placement n=15 Participants Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. Placement of a dental implant: Type 1 implant placement Type 2 implant placement
Modified Bleeding Index	0.12 units on a scale Standard Error 0.08	0.07 units on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Up to 5 years after baseline

Population: No data were collected or analyzed for this outcome measure

Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.

Outcome measures

Outcome data not reported

Adverse Events

Type 1 Implant Placement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Type 2 Implant Placement

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	Type 1 Implant Placement n=17 participants at risk Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement	Type 2 Implant Placement n=15 participants at risk Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. Placement of a dental implant: Type 1 implant placement Type 2 implant placement
Surgical and medical procedures Swelling and bruising	0.00% 0/17 • Up to 3 months after crown delivery	13.3% 2/15 • Number of events 2 • Up to 3 months after crown delivery

Additional Information

Guy Huynh-Ba

UTHSCSA Periodontics

Phone: 2105673569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place