Comparison of Two Gingival Displacement Procedures; a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Percentage of Errors in Impressions Made for Indirect Restorations
Study Overview
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.
Detailed Description
Background: Indirect fixed prosthodontic restorations are widely used for the restoration of teeth. The fabrication of a well-fitting indirect restoration requires an accurate impression which captures the cervical finish line. Dentists have a hard time making proper impressions, with a reported 56% of impressions sent to labs being inadequate. The most common deficiency is inadequate recording of the cervical finish line. The primary reason for this inadequacy is deficient gingival displacement technique. More effective and efficient gingival displacement procedure can lead to clinically improved fixed restorations, less patient chair time, and less patient discomfort.
Materials and Methods: Sixty (60) patients will be recruited from the University of North Carolina (UNC) School of Dentistry (SOD), and they will be randomly split into 2 equal sized groups: 30 patients cordless gingival displacement procedure (Aquasil Ultra Cordless, Dentsply International); 30 patients traditional corded technique using Aquasil Ultra Polyvinyl siloxane (PVS) impression material, Dentsply International, gingival displacement cord (Ultrapak, Ultradent Products International) hydrated with aluminum chloride hexahydrate (Hemodent, Premier Dental Products Company). Patient inclusion criteria include: 1) requires indirect restoration/s. 2) probing depths 4mm or less. 3) No bleeding on probing. 4) finish line 0-1mm sub-gingival.
Specific Aims:
- To examine if a cordless gingival displacement procedure can properly displace gingival tissue to facilitate acceptable impressions that accurately capture the prepared cervical finish line for the fabrication of indirect fixed prosthodontic restorations. These impressions will be digitally scanned, and then all of the impression scans will be evaluated for acceptability based on a set of criteria (evaluation form). The evaluations will be conducted by 2 standardized individuals.
- To determine if a cordless gingival displacement procedure facilitates impressions that area at least as good as the traditional corded gingival displacement procedure. The impression scans will be evaluated and then a comparison will be made between the 2 groups of impressions.
- To determine if a cordless gingival displacement procedure is more time efficient than the traditional corded procedure. All procedures will be timed, starting when the gingival displacement procedure is commenced and ending when the impression is removed from the patient's mouth.
- To determine if a cordless gingival displacement procedure causes less trauma and discomfort to the patient than the traditional corded procedure. Patient discomfort will be evaluated with a 3 question written survey (0-10 scale answers).
The hypothesis contemplated in this proposal explores if a cordless gingival displacement procedure can properly displace gingival tissues to facilitate an acceptable impression that accurately captures the prepared cervical finish line for the fabrication of indirect fixed prosthodontic restorations. Our objective is to identify if a new procedure can improve the efficiency of a traditionally technique-sensitive procedure in dentistry.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients must be adult males or females over the age of
- •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).
Exclusion Criteria
- •Individuals who have a chronic disease with oral manifestations.
- •Individuals who exhibit gross oral pathology.
- •Smokers, Diabetics
Arms & Interventions
Aquasil Ultra Cordless, Dentsply
Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus.
Intervention: Aquasil Ultra Cordless, Dentsply (Device)
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.
Intervention: Ultrapak, Ultradent cord (Device)
Outcomes
Primary Outcomes
Percentage of Errors in Impressions Made for Indirect Restorations
Time Frame: Through impression completion, an average of 10-20 minutes or when impression material is completely set
Impressions will be assessed for technique errors
Mean Time Required to Make the Impression
Time Frame: 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.
Mean Patient Discomfort Scores
Time Frame: 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.
Secondary Outcomes
- 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 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 in the Maxillary and Mandibular Arch(Through impression completion, an average of 10-20 minutes or when impression material is completely set)
- Mean Patient Discomfort Score Comparison Based on Maxillary and Mandibular Arch(Through impression completion,an average of 10-20 minutes or when impression material is completely set)