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Trial Outcomes & Findings for Comparison of Two Gingival Displacement Procedures (NCT NCT02716727)

NCT ID: NCT02716727

Last Updated: 2020-08-18

Results Overview

Impressions will be assessed for technique errors

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Through impression completion, an average of 10-20 minutes or when impression material is completely set

Results posted on

2020-08-18

Participant Flow

Participant milestones

Participant milestones
Measure
Aquasil Ultra Cordless, Dentsply
Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus. Aquasil Ultra Cordless, Dentsply: Cordless gingival displacement procedure
Ultrapak, Ultradent Cord
The knitted cord is used for physical displacement of gingival tissue. Cord is placed in the gingival sulcus and left in place for at least 4 minutes to achieve gingival displacement. Ultrapak, Ultradent cord: Cordless gingival displacement procedure
Overall Study
STARTED
7
9
Overall Study
COMPLETED
7
9
Overall Study
NOT COMPLETED
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
Aquasil Ultra Cordless, Dentsply
n=7 Participants
Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus. Aquasil Ultra Cordless, Dentsply: Cordless gingival displacement procedure
Ultrapak, Ultradent Cord
n=9 Participants
The knitted cord is used for physical displacement of gingival tissue. Cord is placed in the gingival sulcus and left in place for at least 4 minutes to achieve gingival displacement. Ultrapak, Ultradent cord: Cordless gingival displacement procedure
Total
n=16 Participants
Total of all reporting groups
Age, Continuous
56.2 years
STANDARD_DEVIATION 15.01 • n=7 Participants
65.0 years
STANDARD_DEVIATION 9.03 • n=9 Participants
60.5 years
STANDARD_DEVIATION 4.2 • n=16 Participants
Sex: Female, Male
Female
2 Participants
n=7 Participants
6 Participants
n=9 Participants
8 Participants
n=16 Participants
Sex: Female, Male
Male
5 Participants
n=7 Participants
3 Participants
n=9 Participants
8 Participants
n=16 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
7 Participants
n=7 Participants
9 Participants
n=9 Participants
16 Participants
n=16 Participants

PRIMARY outcome

Timeframe: Through impression completion, an average of 10-20 minutes or when impression material is completely set

Impressions will be assessed for technique errors

Outcome measures

Outcome measures
Measure
Aquasil Ultra Cordless, Dentsply
n=7 Participants
Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus. Aquasil Ultra Cordless, Dentsply: Cordless gingival displacement procedure
Ultrapak, Ultradent Cord
n=9 Participants
The knitted cord is used for physical displacement of gingival tissue. Cord is placed in the gingival sulcus and left in place for at least 4 minutes to achieve gingival displacement. Ultrapak, Ultradent cord: Cordless gingival displacement procedure
Percentage of Errors in Impressions Made for Indirect Restorations
Pressure of Tray on Soft Tissue
0 percentage of impressions
11.1 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Void on Preparation
85.7 percentage of impressions
88.8 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Show-through of Occlusal/Incisal Edges
0 percentage of impressions
22.2 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Tissue Over Finish Line
42.9 percentage of impressions
11.1 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Voids/Bubbles
85.7 percentage of impressions
33.3 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Lack of Wash Material
28.6 percentage of impressions
44.4 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Tearing
71.4 percentage of impressions
11.1 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Cotton Roll Attached
0 percentage of impressions
11.1 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Inadequate Fusion Between Wash & Tray Material
57.1 percentage of impressions
11.1 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Lack of Polymerization
14.3 percentage of impressions
0 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Inadequate Retention
0 percentage of impressions
0 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Retraction Cord Attached
0 percentage of impressions
11.1 percentage of impressions
Percentage of Errors in Impressions Made for Indirect Restorations
Blood on the Impression
0 percentage of impressions
33.3 percentage of impressions

PRIMARY outcome

Timeframe: Through impression completion, an average of 10-20 minutes or when impression material is completely set

The time required to perform the impression procedures from the start of the gingival displacement procedure to completion of impression.

Outcome measures

Outcome measures
Measure
Aquasil Ultra Cordless, Dentsply
n=7 Participants
Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus. Aquasil Ultra Cordless, Dentsply: Cordless gingival displacement procedure
Ultrapak, Ultradent Cord
n=9 Participants
The knitted cord is used for physical displacement of gingival tissue. Cord is placed in the gingival sulcus and left in place for at least 4 minutes to achieve gingival displacement. Ultrapak, Ultradent cord: Cordless gingival displacement procedure
Mean Time Required to Make the Impression
5.92 minutes
Standard Deviation 8.57
9.81 minutes
Standard Deviation 8.57

PRIMARY outcome

Timeframe: From start of visit until the end of the visit, approximately 3 hours

Patient discomfort will be assessed using the Wong-Baker FACES Pain Rating Scale™.The FACES Pain Scale is a dimensionless 10-point Likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. Patients self-reported pain using the FACES evaluation at the beginning of the appointment, immediately before start of impression procedure, immediately after the impression procedure completed, and at the end of the appointment.

Outcome measures

Outcome measures
Measure
Aquasil Ultra Cordless, Dentsply
n=7 Participants
Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus. Aquasil Ultra Cordless, Dentsply: Cordless gingival displacement procedure
Ultrapak, Ultradent Cord
n=9 Participants
The knitted cord is used for physical displacement of gingival tissue. Cord is placed in the gingival sulcus and left in place for at least 4 minutes to achieve gingival displacement. Ultrapak, Ultradent cord: Cordless gingival displacement procedure
Mean Patient Discomfort Scores
Immediately Before Starting Impression
8.64 score on a scale
Standard Deviation 7.87
7.43 score on a scale
Standard Deviation 7.87
Mean Patient Discomfort Scores
Start of Visit
7.64 score on a scale
Standard Deviation 6.03
8.31 score on a scale
Standard Deviation 6.03
Mean Patient Discomfort Scores
Immediately After Impression Completed
1.85 score on a scale
Standard Deviation 1.57
2.12 score on a scale
Standard Deviation 1.45
Mean Patient Discomfort Scores
At End of Visit
8.00 score on a scale
Standard Deviation 7.58
8.00 score on a scale
Standard Deviation 7.58

SECONDARY outcome

Timeframe: Through impression completion, an average of 10-20 minutes or when impression material is completely set

Population: Due to loss of key study personnel these data were not collected.

Accuracy of the impression assessed for technique errors based on the clinical experience of the provider.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through impression completion, an average of 10-20 minutes or when impression material is completely set

Population: Due to loss of key study personnel these data were not collected.

The time required to perform the impression procedures from the start of the gingival displacement procedure to completion of impression based on the clinical experience of the provider.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of visit until the end of the visit, approximately 3 hours

Population: Due to loss of key study personnel these data were not collected.

Patient discomfort will be assessed based on the clinical experience of the provider using the Wong-Baker FACES Pain Rating Scale™.The FACES Pain Scale is a dimensionless 10-point Likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. Patients self-reported pain using the FACES evaluation at the beginning of the appointment, immediately before start of impression procedure, immediately after the impression procedure completed, and at the end of the appointment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through impression completion, an average of 10-20 minutes or when impression material is completely set

Population: Due to loss of key study personnel these data were not collected.

Accuracy of the impression assessed for technique errors based on the location of the tooth in the mouth (maxillary and mandibular arch).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through impression completion, an average of 10-20 minutes or when impression material is completely set

Population: Due to loss of key study personnel these data were not collected.

The time required to perform the impression procedures from the start of the gingival displacement procedure to completion of impression based on the location of the tooth in the mouth (maxillary and mandibular arch).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through impression completion,an average of 10-20 minutes or when impression material is completely set

Population: Due to loss of key study personnel these data were not collected.

Patient discomfort will be assessed based on the location of the tooth in the mouth (maxillary and mandibular arch) using the Wong-Baker FACES Pain Rating Scale™.The FACES Pain Scale is a dimensionless 10-point Likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. Patients self-reported pain using the FACES evaluation at the beginning of the appointment, immediately before start of impression procedure, immediately after the impression procedure completed, and at the end of the appointment.

Outcome measures

Outcome data not reported

Adverse Events

Aquasil Ultra Cordless, Dentsply

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ultrapak, Ultradent Cord

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

Sumitha Ahmed, DDS

University of North Carolina at Chapel Hill

Phone: 919-537-3946

Results disclosure agreements

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