Trial Outcomes & Findings for Immediate Loading Versus Delayed Loading in Single-implant (NCT NCT02770846)

Results Overview

Digital intra-oral periapical radiographs at different time points. The marginal bone level is measured after calibration. Measurements are taken from the implant-abutment junction to the marginal bone level (millimetres). Change in marginal bone level is calculated by comparing bone-to-implant contact level of all appointments to radiographic baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Baseline to 12 months

Results posted on

2020-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Immediate Loading Immediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion Immediate loading	Delayed Loading Delayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown. Delayed loading
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immediate Loading Versus Delayed Loading in Single-implant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Loading n=25 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=25 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.	Total n=50 Participants Total of all reporting groups
Sex: Female, Male Male	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	40.8 years STANDARD_DEVIATION 13.3 • n=5 Participants	40.9 years STANDARD_DEVIATION 15.5 • n=7 Participants	40.9 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.

Digital intra-oral periapical radiographs at different time points. The marginal bone level is measured after calibration. Measurements are taken from the implant-abutment junction to the marginal bone level (millimetres). Change in marginal bone level is calculated by comparing bone-to-implant contact level of all appointments to radiographic baseline.

Outcome measures

Outcome measures
Measure	Immediate Loading n=25 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=24 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
Change in Level of Marginal Bone	-0.57 mm Standard Deviation 0.52	-0.69 mm Standard Deviation 0.69

PRIMARY outcome

Timeframe: After 12 months

Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.

The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated. The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined. Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome.

Outcome measures

Outcome measures
Measure	Immediate Loading n=25 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=24 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
Pink Esthetic Score	10.36 units on a scale Standard Deviation 2.46	10.67 units on a scale Standard Deviation 2.32

PRIMARY outcome

Timeframe: Pre-surgery

The Oral Health Impact Profile 14 (OHIP-14) measure oral health related quality of life. The oral health-related quality of life is calculated using the Swedish validated version of the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaires are completed at the beginning of the treatment and 12 months after the definitive crown placement. The scale consists of 14 variables that are scored 1,2,3,4 or 5, the 14 variables scores are combined. Scale range 14-70, 14 minimum and 70 maximum. A low score represent a better oral health related quality of life.

Outcome measures

Outcome measures
Measure	Immediate Loading n=25 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=25 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
Oral Health Impact Profile 14	26.68 units on a scale Standard Deviation 9.3	23.40 units on a scale Standard Deviation 8.64

PRIMARY outcome

Timeframe: Baseline

Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.

The White esthetic score (WES) measures the aesthetic appearance of the implant crown. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated. The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined. Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome.

Outcome measures

Outcome measures
Measure	Immediate Loading n=25 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=24 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
White Esthetic Score	7.00 units on a scale Standard Deviation 1.41	7.00 units on a scale Standard Deviation 1.64

PRIMARY outcome

Timeframe: Baseline

Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.

The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated. The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined. Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome.

Outcome measures

Outcome measures
Measure	Immediate Loading n=25 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=24 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
Pink Esthetic Score	8.56 score on a scale Standard Deviation 2.27	9.42 score on a scale Standard Deviation 2.98

PRIMARY outcome

Timeframe: After 12 months

Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.

The Oral Health Impact Profile 14 (OHIP-14) measure oral health related quality of life. The oral health-related quality of life is calculated using the Swedish validated version of the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaires are completed at the beginning of the treatment and 12 months after the definitive crown placement. The scale consists of 14 variables that are scored 1,2,3,4 or 5, the 14 variables scores are combined. Scale range 14-70, 14 minimum and 70 maximum. A low score represent a better oral health related quality of life.

Outcome measures

Outcome measures
Measure	Immediate Loading n=25 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=24 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
Oral Health Impact Profile 14 (OHIP-14)	16.48 units on a scale Standard Deviation 3.87	15.38 units on a scale Standard Deviation 2.58

PRIMARY outcome

Timeframe: After 12 months

Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.

The White esthetic score (WES) measures the aesthetic appearance of the implant crown. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated. The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined. Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome.

Outcome measures

Outcome measures
Measure	Immediate Loading n=25 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=24 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
White Esthetic Score	7.76 Score on a scale Standard Deviation 1.30	7.87 Score on a scale Standard Deviation 1.39

PRIMARY outcome

Timeframe: Baseline to 5 years

Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event. 1 patient was lost to follow-up in the immediate loading group and 1 in the delayed loading group.

Digital intra-oral periapical radiographs at different time points. The marginal bone level is measured after calibration. Measurements are taken from the implant-abutment junction to the marginal bone level (millimetres). Change in marginal bone level is calculated by comparing bone-to-implant contact level of all appointments to radiographic baseline.

Outcome measures

Outcome measures
Measure	Immediate Loading n=24 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=23 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
Change in Level of Marginal Bone	-0.50 mm Standard Deviation 0.73	-0.54 mm Standard Deviation 0.65

PRIMARY outcome

Timeframe: After 5 year

Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event. 1 patient was lost to follow-up in the immediate loading group and 1 in the delayed loading group.

The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated. The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined. Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome.

Outcome measures

Outcome measures
Measure	Immediate Loading n=24 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=23 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
Pink Esthetic Score	11.00 Score on a scale Standard Deviation 2.08	11.17 Score on a scale Standard Deviation 2.39

PRIMARY outcome

Timeframe: 5 years

Population: In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event. 1 patient was lost to follow-up in the immediate loading group and 1 in the delayed loading group.

The White esthetic score (WES) measures the aesthetic appearance of the implant crown. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated. The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined. Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome.

Outcome measures

Outcome measures
Measure	Immediate Loading n=24 Participants Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=23 Participants Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
White Esthetic Score	7.63 Score on a scale Standard Deviation 1.53	7.91 Score on a scale Standard Deviation 1.53

Adverse Events

Immediate Loading

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Loading

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Immediate Loading n=25 participants at risk Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.	Delayed Loading n=25 participants at risk Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
Surgical and medical procedures Dental implant loss	0.00% 0/25 • 1 year Serious events: loss of dental implant. Other adverse event: prosthetic restoration complications.	4.0% 1/25 • Number of events 1 • 1 year Serious events: loss of dental implant. Other adverse event: prosthetic restoration complications.

Other adverse events

Adverse event data not reported

Additional Information

Björn Gjelvold

Folktandvården Skåne AB

Phone: +46709467870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place