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Trial Outcomes & Findings for Evaluation of Using Different Screwed Abutment Height (NCT NCT06017115)

NCT ID: NCT06017115

Last Updated: 2025-06-26

Results Overview

Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters). The mean of this two-points for each implant was calculated. Afterwards, the mean for the mesial implants, distal and total implant sample per group was calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

After implant loading (baseline)and once every year to 24 months follow-up

Results posted on

2025-06-26

Participant Flow

Unit of analysis: implant

Participant milestones

Participant milestones
Measure
Control Group
Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery) Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group): Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)
Test Group
Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group): Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)
Overall Study
STARTED
12 24
18 36
Overall Study
COMPLETED
12 24
18 36
Overall Study
NOT COMPLETED
0 0
0 0

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
Control Group: Two Stage Approach
n=24 implant
Implant placement surgery with close screw and sumerge implant approach
Test Group: One Stage Approach
n=36 implant
Implant placement surgery with trans-epithelial abutment
Total
n=60 implant
Total of all reporting groups
Age, Continuous
70.90 years
STANDARD_DEVIATION 9.09 • n=12 Participants
63.28 years
STANDARD_DEVIATION 9.79 • n=18 Participants
65.77 years
STANDARD_DEVIATION 10.23 • n=30 Participants
Sex: Female, Male
Female
3 Participants
n=12 Participants
6 Participants
n=18 Participants
9 Participants
n=30 Participants
Sex: Female, Male
Male
9 Participants
n=12 Participants
12 Participants
n=18 Participants
21 Participants
n=30 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Marginal bone loss
1.17 millimeters
STANDARD_DEVIATION 0.36 • n=24 implant
0.83 millimeters
STANDARD_DEVIATION 0.26 • n=36 implant
0.97 millimeters
STANDARD_DEVIATION 0.34 • n=60 implant

PRIMARY outcome

Timeframe: After implant loading (baseline)and once every year to 24 months follow-up

Population: A total of 30 patients (60 implants), 12 of the control group (24 implants) and 18 of the test group (36 implants) were assessed after 24 months follow-up.

Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters). The mean of this two-points for each implant was calculated. Afterwards, the mean for the mesial implants, distal and total implant sample per group was calculated.

Outcome measures

Outcome measures
Measure
Control Group
n=24 implants
Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery) Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group): Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)
Test Group
n=36 implants
Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group): Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)
Marginal Bone Loss
Total implants at 24 months
1.17 millimeters
Standard Deviation 0.35
0.83 millimeters
Standard Deviation 0.25
Marginal Bone Loss
Mesial implant at 24 months
1.28 millimeters
Standard Deviation 0.47
0.96 millimeters
Standard Deviation 0.36
Marginal Bone Loss
Distal implant at 24 months
1.06 millimeters
Standard Deviation 0.53
0.71 millimeters
Standard Deviation 0.27
Marginal Bone Loss
Total implants at 12 months
1.13 millimeters
Standard Deviation 0.34
0.80 millimeters
Standard Deviation 0.26
Marginal Bone Loss
Mesial implant at 12 months
1.25 millimeters
Standard Deviation 0.46
0.93 millimeters
Standard Deviation 0.38
Marginal Bone Loss
Distal implant at 12 months
0.81 millimeters
Standard Deviation 0.41
0.67 millimeters
Standard Deviation 0.27

SECONDARY outcome

Timeframe: After implant loading (baseline)and once every year to 36 months follow-up

Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After implant loading (baseline)and once every year to 36 months follow-up

Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After implant loading (baseline)and once every year to 36 months follow-up

Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).

Outcome measures

Outcome data not reported

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. Jordi Gargallo

Universitat Internacional de Catalunya

Phone: +34 935 04 20 00

Results disclosure agreements

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