Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences

Mouth, Edentulous Clinical Trial

Official title:

Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02521935
• Other study ID #: 14-1811
• Status: Withdrawn
• Phase: N/A
• First received: July 16, 2015
• Last updated: April 25, 2017
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: April 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: To compare complete denture outcomes between conventional and digital denture fabrication processes.

Participants: Sixteen edentulous adult patients in the University of North Carolina School of Dentistry Student Clinic who are seeking removable complete dentures.

Procedures (methods): Two complete sets of dentures will be fabricated for each subject: one using the conventional process (A) and the other using a digital process (B). Variability will be assessed by the research team, the treating dental students, an independent prosthodontist, and the patients through quantitative measures. Case selection and results analysis will be evaluated with recognition of the Prosthodontic Diagnostic Index.

Description:

Rationale for Study Design An AB/BA (conventional=A, digital=B) crossover design with no wash-out period is flawed for this study, and its weakness is the potential for a carryover effect (benefits or risks associated with treatment A carry over to treatment B). A wash-out period is not feasible for this study because it would require the patient-subjects to suspend use of their dentures for the duration of the wash-out period.

The Investigators have decided to conduct the study using the ABB/BAA crossover design, which does not require a wash-out period and will permit testing and discounting of a possible carryover effect. In addition, this design is more appropriate for a small sample size than the AB/BA design.

The investigators are adding to the scant literature on digital dentures, information that has never before been studied - the retention, aesthetics, and stability of digital dentures compared to conventional dentures. Additionally, the investigators will have longitudinal data on these characteristics regarding digital dentures.

If the Functional Assessment of Dentures (FAD) and the patient evaluation show positive results for the digital dentures, this could lead to increased use of the Computer -Aided Design/ Computer -Aided Manufacturing (CADCAM) fabrication method which, in turn, would allow greater numbers of people to benefit from the advantages of the digital dentures as described earlier in this application (e.g., a better fit, fewer visits with less time in the chair, less biofilm formation, etc.)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. UNC School of Dentistry Student Clinic patients requiring maxillary and mandibular complete dentures

2. Ages 18 to 99, inclusive

3. Able to read, speak, and understand English

4. Without natural tooth or implant supported overdentures

5. Edentulous in both jaws for at least 6 months

6. Any Prosthodontic Diagnostic Index (PDI) type with a preference given to Types 1-3

Exclusion Criteria:

1. Non-registered patient in UNC School of Dentistry student clinics

2. Patient not able or unwilling to give consent

3. Subject had extractions within last 6 months

Related Conditions & MeSH terms

• Mouth, Edentulous

Intervention

Device:
• Complete traditional dentures
Arm 1-Standard Treatment Sequence for Traditional Removable Dentures in a Dental School Clinic (9 Appointments): Appointment 1: Examination & diagnosis & initial impressions. Appointment 2: Secondary impressions. Appointment 3: Secondary or definitive impressions (Often 2 appointments are needed to border mold and impression) Appointment 4: Maxillo-mandibular jaw relation records (both centric and vertical relation). Tooth selection. Appointment 5: Wax-trial denture try-in. Appointment 6: Insertion and instructions for care of definitive prostheses. Appointments 7-9 Post adjustments
• Complete CADCAM dentures
Arm 2-Standard Treatment Sequence for Digital Dentures in a Dental School Clinic (5 appointments): Appointment 1: Exam, diagnosis, & tray selection (begin impressions) Appointment 2: Definitive impressions and Maxillomandibula relations Appointment 3: Wax-trial arrangement Appointment 4: Insertion and instructions for care of definitive prosthesis Appointment 5: Post adjustment/s (Less post insertion adjustments are anticipated due to CADCAM milling of the denture base and less polymerization shrinkage

Locations

Country	Name	City	State
United States	University of North Carolina School of Dentistry Student Clinics	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Global Dental Science, LLC

Country where clinical trial is conducted

United States, 

References & Publications (16)

Alfadda SA. The relationship between various parameters of complete denture quality and patients' satisfaction. J Am Dent Assoc. 2014 Sep;145(9):941-8. doi: 10.14219/jada.2013.48. — View Citation

Allen PF, McMillan AS, Walshaw D. A patient-based assessment of implant-stabilized and conventional complete dentures. J Prosthet Dent. 2001 Feb;85(2):141-7. — View Citation

Anastassiadou V, Naka O, Heath MR, Kapari D. Validation of indices for functional assessment of dentures. Gerodontology. 2002 Jul;19(1):46-52. — View Citation

Bidra AS, Taylor TD, Agar JR. Computer-aided technology for fabricating complete dentures: systematic review of historical background, current status, and future perspectives. J Prosthet Dent. 2013 Jun;109(6):361-6. doi: 10.1016/S0022-3913(13)60318-2. Review. — View Citation

Corrigan PJ, Basker RM, Farrin AJ, Mulley GP, Heath MR. The development of a method for functional assessment of dentures. Gerodontology. 2002 Jul;19(1):41-5. — View Citation

Darvell BW, Clark RK. The physical mechanisms of complete denture retention. Br Dent J. 2000 Sep 9;189(5):248-52. Review. — View Citation

Fenlon MR, Sherriff M, Walter JD. An investigation of factors influencing patients' use of new complete dentures using structural equation modelling techniques. Community Dent Oral Epidemiol. 2000 Apr;28(2):133-40. — View Citation

Goodacre CJ, Garbacea A, Naylor WP, Daher T, Marchack CB, Lowry J. CAD/CAM fabricated complete dentures: concepts and clinical methods of obtaining required morphological data. J Prosthet Dent. 2012 Jan;107(1):34-46. doi: 10.1016/S0022-3913(12)60015-8. — View Citation

Infante L, Yilmaz B, McGlumphy E, Finger I. Fabricating complete dentures with CAD/CAM technology. J Prosthet Dent. 2014 May;111(5):351-5. doi: 10.1016/j.prosdent.2013.10.014. Epub 2014 Jan 23. — View Citation

Kattadiyil MT, Goodacre CJ, Baba NZ. CAD/CAM complete dentures: a review of two commercial fabrication systems. J Calif Dent Assoc. 2013 Jun;41(6):407-16. — View Citation

Lee WS, Kim WC, Kim HY, Kim WT, Kim JH. Evaluation of different approaches for using a laser scanner in digitization of dental impressions. J Adv Prosthodont. 2014 Feb;6(1):22-9. doi: 10.4047/jap.2014.6.1.22. Epub 2014 Feb 14. — View Citation

McCord JF. Contemporary techniques for denture fabrication. J Prosthodont. 2009 Feb;18(2):106-11. doi: 10.1111/j.1532-849X.2009.00439.x. Review. — View Citation

Parvizi A, Lindquist T, Schneider R, Williamson D, Boyer D, Dawson DV. Comparison of the dimensional accuracy of injection-molded denture base materials to that of conventional pressure-pack acrylic resin. J Prosthodont. 2004 Jun;13(2):83-9. — View Citation

Sato Y, Hamada S, Akagawa Y, Tsuga K. A method for quantifying overall satisfaction of complete denture patients. J Oral Rehabil. 2000 Nov;27(11):952-7. — View Citation

Sato Y, Tsuga K, Akagawa Y, Tenma H. A method for quantifying complete denture quality. J Prosthet Dent. 1998 Jul;80(1):52-7. — View Citation

WOELFEL JB, PAFFENBARGER GC, SWEENEY WT. CLINICAL EVALUATION OF COMPLETE DENTURES MADE OF 11 DIFFERENT TYPES OF DENTURE BASE MATERIALS. J Am Dent Assoc. 1965 May;70:1170-88. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the overall comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures	evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD= Functional Assessment of Dentures)	2 years
Secondary	comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures	evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD= Functional Assessment of Dentures)	baseline = 4 weeks
Secondary	comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures	evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD)	3 months
Secondary	comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures	evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD)	6 months
Secondary	comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures	evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD)	1 year
Secondary	comparison of patient satisfaction between digital dentures and traditional dentures	patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale	baseline = 4 weeks
Secondary	comparison of patient satisfaction between digital dentures and traditional dentures	patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale	3 months
Secondary	comparison of patient satisfaction between digital dentures and traditional dentures	patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale	6 months
Secondary	comparison of patient satisfaction between digital dentures and traditional dentures	patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale	1 year
Secondary	comparison of patient satisfaction between digital dentures and traditional dentures	patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale	2 year
Secondary	bite force comparison between digital dentures and traditional dentures	using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement	baseline = 4 weeks
Secondary	bite force comparison between digital dentures and traditional dentures	using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement	3 months
Secondary	bite force comparison between digital dentures and traditional dentures	using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement	6 months
Secondary	bite force comparison between digital dentures and traditional dentures	using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement	1 year
Secondary	bite force comparison between digital dentures and traditional dentures	using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement	2 year