Trial Outcomes & Findings for Immediate Loading Of Dental Implants: A Pilot Clinical Study (NCT NCT01644058)

Results Overview

Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

4 months

Results posted on

2017-06-02

Participant Flow

Calling patients on the waiting list of the undergraduate implant clinic of the Université de Montréal and referrals from active study subjects.

Participant milestones

Participant milestones
Measure	Immediate Loading Immediate loading of 2 endo-osseous mandibular implants
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immediate Loading Of Dental Implants: A Pilot Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Loading n=18 Participants Immediate loading of 2 endo-osseous mandibular implants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	62.4 years STANDARD_DEVIATION 7.65 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment Canada	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).

Outcome measures

Outcome measures
Measure	Immediate Loading n=18 Participants Immediate loading of 2 endo-osseous mandibular implants
Patient Satisfaction With the Immediate Loading Protocol	40.3 millimeters Standard Deviation 34.9 • Interval 0.0 to 99.0

PRIMARY outcome

Timeframe: 4 months

Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.

Outcome measures

Outcome measures
Measure	Immediate Loading n=18 Participants Immediate loading of 2 endo-osseous mandibular implants
Oral-health-related Quality of Life With the Immediate Loading Protocol	66.8 units on a scale Standard Deviation 19.1

Adverse Events

Immediate Loading

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

Elham Emami, DDS, MSc, PhD

Université de Montréal

Phone: 514-343-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place