Comparison of Two Gingival Displacement Procedures

NCT02716727 | Completed Results

• 1 other identifier: 15-1787
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To compare the quality of impressions made with a cordless gingival displacement procedure versus impressions made with a corded technique. The devices and materials used in both procedures are FDA-approved, marketed, and will be used according to label. Participants: Approximately sixty (60) adult patients who are treatment planned for indirect restorations (crowns) at the UNC School of Dentistry. Procedures (methods): Participants will be randomized to receive either the cordless gingival displacement procedure (Aquasil Ultra Cordless, Dentsply), or the corded technique (Ultrapak, Intradent) followed by impression with Aquasil Ultra, Dentsply. Participants will complete the Faces pain scale. Impressions will be photographed, digitally scanned, and evaluated.

Conditions

Gingival Retraction Techniques

Outcome Measures

Primary Outcomes (3)

• Percentage of Errors in Impressions Made for Indirect Restorations

  Impressions will be assessed for technique errors

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

• Mean Time Required to Make the Impression

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

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

• Mean Patient Discomfort Scores

  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.

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

Secondary Outcomes (6)

• Comparison of Percentage of Impression Errors Made by Residents and Faculty

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

• Comparison of the Time Required to Make Impressions Between Residents and Faculty

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

• Mean Patient Discomfort Score Comparison for Procedures Completed by Residents and Faculty

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

• Comparison of Percentage of Impression Errors Based on Maxillary and Mandibular Arch

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

• Comparison of the Time Required to Make Impressions in the Maxillary and Mandibular Arch

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

Study Arms (2)

Aquasil Ultra Cordless, Dentsply

ACTIVE COMPARATOR

Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus.

Device: Aquasil Ultra Cordless, Dentsply

Ultrapak, Ultradent cord

ACTIVE COMPARATOR

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.

Device: Ultrapak, Ultradent cord

Interventions

Aquasil Ultra Cordless, Dentsply DEVICE

Cordless gingival displacement procedure

Aquasil Ultra Cordless, Dentsply

Ultrapak, Ultradent cord DEVICE

Cordless gingival displacement procedure

Ultrapak, Ultradent cord

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be adult males or females over the age of 18.
• Patients must be able and willing to follow study procedures and instructions.
• Patients must have read, understood and signed an informed consent form.
• Patients must be in good general health.
• Patient must require one or more indirect restorations.
• Probing pocket depths around the treatment tooth/teeth must be 4mm or less.
• There must be no bleeding on probing around the treatment tooth/teeth.
• The prepared finish line must be between 0 to 1mm sub-gingival (inclusive).

You may not qualify if:

• Individuals who have a chronic disease with oral manifestations.
• Individuals who exhibit gross oral pathology.
• Smokers, Diabetics

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

• Title: Sumitha Ahmed, DDS
• Organization: University of North Carolina at Chapel Hill

sumitha_ahmed@unc.edu

919-537-3946

Study Officials

• Sumitha Ahmed, BDS, MS

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 23, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 18, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)