Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02793037
Other study ID # UW 15-205
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date June 2019

Study information

Verified date August 2020
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Trial Design - Objectives and Purpose The aim of this study is to perform a proof of concept for the successful retention and outcome measures of zirconia RBBs for the replacement of missing canine or posterior teeth (6-8mm span) and that they will exhibit similar survival rates (95%) as metal ceramic RBBs over 3 years and short term (Botelho 2006).

The use of monolithic extra-coronal zirconia RBBs in the posterior region does not appear to have been reported in the literature (A search pf Pub Med and Google Scholar has not shown any similar studies that have been published - pubmed.gov; Keywords: "zirconia", "resin", "clinical" assessed on 17/10/2015 AND google scholar; Keywords: "zirconia", "resin bonded fixed partial denture", "resin bonded fixed dental prosthesis", "Maryland", "resin bonded bridge" "posterior", "clinical") In addition, currently there appear to be no clinical trials planned or finished in this area (clinicaltrial.gov; Keywords: "zirconia", "resin" assessed on 17/10/2015) using zirconia RBBs in the posterior region. This reveals that there is a gap in the literature on the use of zirconia for replacing posterior teeth with such prostheses.

The primary outcome measures would be: success ie. prosthesis retention ie. does not fall out

The secondary outcome measures would be:

- complications of the prosthesis such as tipping, drifting or fracture.

- patient centered outcomes (satisfaction and oral health related quality of life) on the RBBs The hypothesis is that 2-unit cantilevered zirconia RBBs will be as successful as current data on 2-unit cantilevered metal-ceramic RBBs from this centre and that there will be no difference in the patient centered outcomes.

The Primary review appointments will be at 1, 6, 12, 24 and 36 months. However, longer term follow up will be performed and this centre has experience of such long term studies (9.5 years - Botelho 2014).

A randomized clinical trial (RCT) comparing to metal-ceramic RBBs will NOT be performed as the 5-year success rate of both metal-ceramic (Botelho 2006) and anterior zirconia (Sasse 2014) prosthesis were higher than 95% and this small differences would mean an unattainable large sample size in an equivalence test (Burns 2001).

Significance and implications Zirconia has significant strength and greater stiffness than base metal alloys and displays clinical outcomes comparable to metal-ceramic conventional crowns and bridges (Heintze 2010, Sailer 2007). Well polished zirconia has been observed to have lower wear rates than porcelain (Stober 2014) Zirconia RBBs for posterior tooth replacement will offer an esthetic and biocompatible treatment option to patients over the traditional ceramic-metal RBBs. It is anticipated that patient demand for this would be high as these prostheses should be as successful (retentive).

These results would re-write established dental prosthodontics textbooks and this would be the first centre to report on the routine use of a 2-unit extracoronal all-zirconia RBB for the replacement of missing posterior teeth.

Research plan and methodology The sample pool would be obtained from patients presenting at the Prince Philip Dental Hospital, University of Hong Kong and who request and need replacement of one or more missing teeth.. They will be clinically assessed for eligibility and invited to participate with written consent in the study. After treatment they will be reviewed up to a 3rd year endpoint of the study. Further review beyond this will be undertaken.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- • The patient is over 18 years old.

- A minimum of one single missing canine, premolar, or molar tooth raging in length from 6-8 mm as judged by the span between the contact points of the adjacent teeth from study models..

- After discussion of treatment options, and that RBB is the most suitable treatment option for them, they will be invited to participate in the study.

- The patient will be rendered dentally fit ie. controlled dental disease - no active caries or periodontal disease

- Have a minimum of 12 occluding pairs of natural teeth

- They will have been informed on the nature of the study and signed consent forms agreeing to undertake treatment in the study.

- Patients will be available to be reviewed at 1, 6, 12, 24, and 36 months and longer.

Exclusion Criteria:

- • Patients with active tooth decay.

- Patients with uncontrolled periodontal disease. An RBB abutment with a probing depth greater than 5mm and bleeding on probing.

- Patients with teeth missing opposite to the planned RBB.

- Abutment tooth mobility of 2 or greater (Millers classification).

- Patients with debilitating illnesses or complicating medical conditions.

- Non-vital or root treated abutment teeth.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Zirconia resin bonded bridge


Locations

Country Name City State
China Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong Hong Kong Guangdong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Zirconia bridge clinical retention/survival rate, that is the presence of the zirconia bridge in patients' mouth in review appointment and will be calculated as a percentage of the total bridges placed as well as presented in Kaplan Meier survival curve. 3 years
Secondary Patient satisfaction in terms of oral health related quality of life (OHrQoL) using Oral Health Impact Profile (OHIP) 49-items questionnaire 3 years
Secondary Patient satisfaction in terms of bridge satisfaction in visual analogue scale (VAS) 3 years
Secondary Complications/adverse outcome associated with Zr bridge reported by patient and detected by clinical assessors 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT06007365 - Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry
Completed NCT05350293 - Evaluation of the Abutment Type Following Oral Implants in Terms of the Surrounding Bone Height N/A
Completed NCT05359549 - Dental Implant Treatment for Two Adjacent Teeth in the Maxillary Aesthetic Region: an Evaluation After 10 Years
Completed NCT05650099 - Peri-implant Health of Dental Implants in the Posterior Region; an Evaluation After 10 Years
Completed NCT02239718 - Novel Use of 2-unit Cantilever Resin-bonded Bridges for Replacing Missing Molar Teeth - a Randomized Clinical Trial N/A
Recruiting NCT04581304 - The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach. N/A
Not yet recruiting NCT06033989 - Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla. N/A
Completed NCT06178796 - Evaluation of the Effect of the Gap Between Bone and Implant Surface on the Implants Stability N/A
Recruiting NCT05649085 - Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study
Completed NCT02123420 - Platform Switching vs Regular Platform Implants. One Year Results From a RCT N/A
Active, not recruiting NCT05362591 - Anterior Resin Bonded Restorations for Adolescent N/A
Active, not recruiting NCT04378140 - Retention and Durability of the Anterior Zirconia Wing Bridge
Completed NCT01953991 - OHQoL With Removable Partial Dentures; a Pilot Study N/A
Active, not recruiting NCT01229995 - Randomized Controlled Clinical Trial of CAD/CAM and Conventionally Fabricated Singl Implant Abutments. N/A
Recruiting NCT04908618 - The Accuracy of Conventional Versus Digital Implant Impression Techniques N/A
Completed NCT05476848 - Relationship Between Oral Findings and Salivary Factors in Sars-Cov-2 Patients N/A
Completed NCT05403099 - Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla N/A
Completed NCT03198520 - REFRAME RPD Post-Market Clinical Study N/A
Active, not recruiting NCT06334081 - Different Surgical Drilling Protocols in Posterior Maxilla N/A
Completed NCT03877419 - Comparison of Different Drilling Speed to Classify Bone Quality by Tactile Sensation on a Saw Bone Model