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Novel Use of 2-unit Cantilever Resin-bonded Bridges for Replacing Missing Molar Teeth - a Randomized Clinical Trial

Primary Purpose

Missing Teeth

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
2-unit cantilevered resin bonded bridge
3-unit fixed movable resin bonded bridge
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Teeth focused on measuring Resin bonded bridges, Clinical trial, Prospective, Survival, Oral health related quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A missing molar tooth that ranges in length from 8-10 mm as judged by the pre-treatment study model. (No more than one per quadrant, if more than one, then different designs will be used in the same mouth.)
  2. The patient has been informed of the various treatment options (dental implants, partial dentures, conventional fixed prosthodontics and no treatment) and if the patient has chosen the RBB as their preferred treatment option, they will be invited to participate in the study
  3. The patient is available to attend for clinical examination at 6 monthly interviews for a period up to 36 months from the start of the study
  4. The patient will have a minimum of 12 occluding pairs of teeth (24 teeth in total)
  5. have a natural dentition opposing the planned RBB
  6. More than 30% bone support on the tooth abutment(s)
  7. Patients will agree to being randomly assigned to one of the two treatment groups, a 2-unit bridge or 3-unit fixed movable bridge
  8. The patient will have been informed on the nature of the study and be required to sign a consent form agreeing to undertake treatment in the study
  9. The patient is over 18 years old
  10. The patient is in sound dental health, ie no active caries and controlled periodontal disease

Exclusion Criteria:

  1. Patients with active tooth decay
  2. Patients with uncontrolled periodontal disease. RBB abutment with a probing depth greater than 5mm and bleeding on probing
  3. Patients with teeth missing opposite to the planned RBB
  4. Abutment tooth mobility of 2 or greater (Millers classification)
  5. Patients with a known allergy to the dental alloy used to make the RBB, ie. Ni/Cr
  6. Patients with debilitating illnesses or complicating medical conditions
  7. Non-vital or root treated abutment teeth

Sites / Locations

  • Department of Prosthodontics, Guanghua School of Stomatology & Affiliated Hospital of Stomatology, Sun Yat-sen University
  • Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2-unit cantilevered resin bonded bridge

3-unit fixed movable resin bonded bridge

Arm Description

Use one tooth as abutment tooth to replace one adjacent missing tooth

Use teeth from both side of the missing tooth space to replace a tooth. The prosthesis is cast in two piece and connected with a fixed-movable joint (semi-precision, allow degree of movement).

Outcomes

Primary Outcome Measures

Survival of bridges (RBB)
Clinically whether the bridge is in subject's mouth. Any complication(s) and associated treatment(s) will be recorded. In case where there is absence of complication/treatment, this bridge is regarded as success. If complication occur and/or treatment (apart from routine periodontal maintenance) is required but the original bridge is still in the mouth, this bridge is regarded as survival. If lost of the original bridge/abutment tooth (teeth) or complication dedicates the remake of the bridge, the bridge is regarded as failed. These will be presented in time to fail (survival) as well as time to complication/treatment (success) by Kaplan Meier curves.
Drifting of abutment teeth after insertion of the bridge
Models will be taken after insertion/cementation of bridge (RBB) (baseline model) and at review appointments (see Time Frame). Vacuum suck down will be made on the baseline model and fitted in subject's mouth during review appointments to screen for any potential tooth movement. In potential tooth movement case, models will be scanned and superimposed for analysis of tooth movement (direction and magnitude of movement)

Secondary Outcome Measures

Complications
Complications related to the abutment teeth / prosthesis (RBB) This is measured from review examinations as well as from patient history (any treatment of the RBB by the third parties other than the study centres) Review examination will look for: debonding, fracture of framework, fracture of veneer material, caries occurring related to retainer on the abutments, extraction related to periodontal disease or root fracture resulting in loss of the entire reconstruction, abutment endodontic or apical radiolucency, probing depth greater than 5mm
Abutment mobility
Tested by two handles of mirror (Grade 0, I, II, III) and periotest (Grade 0: -8 to +9; I: 10 to 19; II: 20 to 29; III: 30-50)
Proximal contact tightness of the abutments
Measured with passing a dental floss and digital tension gauge on metal matrix band
Oral Health related Quality of Life
Measured by Oral Health Impact Profile 49 (OHIP) and 14-item satisfaction (Visual Analogue Scale VAS) OHIP will involve pre-operative (before treatment) as well as peri-operative (after tooth preparation and before RBB cementation) time frame.

Full Information

First Posted
September 4, 2014
Last Updated
August 14, 2020
Sponsor
The University of Hong Kong
Collaborators
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02239718
Brief Title
Novel Use of 2-unit Cantilever Resin-bonded Bridges for Replacing Missing Molar Teeth - a Randomized Clinical Trial
Official Title
Novel Use of 2-unit Cantilever Resin-bonded Bridges for Replacing Missing Molar Teeth - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Tooth replacement is a significant issue in the World and while dental implants and conventional bridges have been used to replace missing teeth, dental implants are too expensive for many and conventional dental bridges are destructive to supporting tooth tissue. Resin-bonded bridges (RBBs) are a conservative and cost effective replacement option that involves minimal tooth preparation, leaving the majority of the tooth intact. They are secured in place with an adhesive cement, which is bonded to the outer enamel layer. Clinical audit of these prostheses at the University of Hong Kong shows two-unit RBBs to have some of the highest success rates in the dental literature for the replacement of missing premolar and incisor teeth. However, for the replacement of molar teeth, two-unit RBBs are not performed, as established protocol and recognised texts contraindicate their use due to concerns with tipping or drifting of supporting teeth. Replacement of a single missing molar tooth can be with a three-unit, fixed-fixed (single-piece casting) or three-unit, fixed-movable (two-part casting). However, the fixed-fixed option has a higher debond failure rate than two-unit RBBs and therefore, at this centre, a modified, 3-unit fixed-movable design is used. This two-part casting allows for minor, independent movements of the supporting teeth and thereby aims to reduce stresses between them and, similarly, reduce de-bonding forces. This has the potential for greater longevity and easier long-term maintenance as if the major part of the bridge debonds it can be recemented. The aim of this unique study is to compare 2-unit and 3-unit RBBs for the replacement of single missing molar tooth in a randomized clinical trial. These two designs will be clinically evaluated at 6 months , 1 year, 2 years and 3 years to observe the outcome measures. The primary outcome will examine the success of the dental prostheses with respects to the need of any clinical intervention to repair or remediate the RBB or supporting tooth. Minor outcome measures will examine fatigue or damage to the prosthesis, changes in bone support, pulpal or periodontal health or tooth mobility. Patient satisfaction and quality of life evaluation of the dental prostheses will also be examined. Will 2-unit RBBs offer patients a simpler, cheaper, and successful option over current designs? This has not been previously reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth
Keywords
Resin bonded bridges, Clinical trial, Prospective, Survival, Oral health related quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2-unit cantilevered resin bonded bridge
Arm Type
Experimental
Arm Description
Use one tooth as abutment tooth to replace one adjacent missing tooth
Arm Title
3-unit fixed movable resin bonded bridge
Arm Type
Active Comparator
Arm Description
Use teeth from both side of the missing tooth space to replace a tooth. The prosthesis is cast in two piece and connected with a fixed-movable joint (semi-precision, allow degree of movement).
Intervention Type
Procedure
Intervention Name(s)
2-unit cantilevered resin bonded bridge
Intervention Description
Use one tooth as abutment tooth to replace one adjacent missing tooth
Intervention Type
Procedure
Intervention Name(s)
3-unit fixed movable resin bonded bridge
Intervention Description
Use teeth from both side of the missing tooth space to replace a tooth. The prosthesis is cast in two piece and connected with a fixed-movable joint (semi-precision, allow degree of movement).
Primary Outcome Measure Information:
Title
Survival of bridges (RBB)
Description
Clinically whether the bridge is in subject's mouth. Any complication(s) and associated treatment(s) will be recorded. In case where there is absence of complication/treatment, this bridge is regarded as success. If complication occur and/or treatment (apart from routine periodontal maintenance) is required but the original bridge is still in the mouth, this bridge is regarded as survival. If lost of the original bridge/abutment tooth (teeth) or complication dedicates the remake of the bridge, the bridge is regarded as failed. These will be presented in time to fail (survival) as well as time to complication/treatment (success) by Kaplan Meier curves.
Time Frame
Three years
Title
Drifting of abutment teeth after insertion of the bridge
Description
Models will be taken after insertion/cementation of bridge (RBB) (baseline model) and at review appointments (see Time Frame). Vacuum suck down will be made on the baseline model and fitted in subject's mouth during review appointments to screen for any potential tooth movement. In potential tooth movement case, models will be scanned and superimposed for analysis of tooth movement (direction and magnitude of movement)
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Complications
Description
Complications related to the abutment teeth / prosthesis (RBB) This is measured from review examinations as well as from patient history (any treatment of the RBB by the third parties other than the study centres) Review examination will look for: debonding, fracture of framework, fracture of veneer material, caries occurring related to retainer on the abutments, extraction related to periodontal disease or root fracture resulting in loss of the entire reconstruction, abutment endodontic or apical radiolucency, probing depth greater than 5mm
Time Frame
Three years
Title
Abutment mobility
Description
Tested by two handles of mirror (Grade 0, I, II, III) and periotest (Grade 0: -8 to +9; I: 10 to 19; II: 20 to 29; III: 30-50)
Time Frame
Three years
Title
Proximal contact tightness of the abutments
Description
Measured with passing a dental floss and digital tension gauge on metal matrix band
Time Frame
Three years
Title
Oral Health related Quality of Life
Description
Measured by Oral Health Impact Profile 49 (OHIP) and 14-item satisfaction (Visual Analogue Scale VAS) OHIP will involve pre-operative (before treatment) as well as peri-operative (after tooth preparation and before RBB cementation) time frame.
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A missing molar tooth that ranges in length from 8-10 mm as judged by the pre-treatment study model. (No more than one per quadrant, if more than one, then different designs will be used in the same mouth.) The patient has been informed of the various treatment options (dental implants, partial dentures, conventional fixed prosthodontics and no treatment) and if the patient has chosen the RBB as their preferred treatment option, they will be invited to participate in the study The patient is available to attend for clinical examination at 6 monthly interviews for a period up to 36 months from the start of the study The patient will have a minimum of 12 occluding pairs of teeth (24 teeth in total) have a natural dentition opposing the planned RBB More than 30% bone support on the tooth abutment(s) Patients will agree to being randomly assigned to one of the two treatment groups, a 2-unit bridge or 3-unit fixed movable bridge The patient will have been informed on the nature of the study and be required to sign a consent form agreeing to undertake treatment in the study The patient is over 18 years old The patient is in sound dental health, ie no active caries and controlled periodontal disease Exclusion Criteria: Patients with active tooth decay Patients with uncontrolled periodontal disease. 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 a known allergy to the dental alloy used to make the RBB, ie. Ni/Cr Patients with debilitating illnesses or complicating medical conditions Non-vital or root treated abutment teeth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G Botelho, BDS MSc PhD
Organizational Affiliation
Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Edward CM Lo, BDS MDS PhD
Organizational Affiliation
Dental Public Health, Faculty of Dentistry, The University of Hong Kong
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yan Wang, BDS MDS PhD
Organizational Affiliation
Department of Prosthodontics, Guanghua School of Stomatology, Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Walter YH Lam, BDS MDS
Organizational Affiliation
Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Prosthodontics, Guanghua School of Stomatology & Affiliated Hospital of Stomatology, Sun Yat-sen University
City
GuangZhou
State/Province
Guangdong
Country
China
Facility Name
Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong
City
Hong Kong
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24685984
Citation
Botelho MG, Ma X, Cheung GJ, Law RK, Tai MT, Lam WY. Long-term clinical evaluation of 211 two-unit cantilevered resin-bonded fixed partial dentures. J Dent. 2014 Jul;42(7):778-84. doi: 10.1016/j.jdent.2014.02.004. Epub 2014 Mar 28.
Results Reference
background
PubMed Identifier
23025467
Citation
Lam WY, Botelho MG, McGrath CP. Longevity of implant crowns and 2-unit cantilevered resin-bonded bridges. Clin Oral Implants Res. 2013 Dec;24(12):1369-74. doi: 10.1111/clr.12034. Epub 2012 Oct 2.
Results Reference
background
PubMed Identifier
16803807
Citation
Botelho MG, Leung KC, Ng H, Chan K. A retrospective clinical evaluation of two-unit cantilevered resin-bonded fixed partial dentures. J Am Dent Assoc. 2006 Jun;137(6):783-8. doi: 10.14219/jada.archive.2006.0290.
Results Reference
background
PubMed Identifier
16220800
Citation
Botelho MG, Dyson JE. Long-span, fixed-movable, resin-bonded fixed partial dentures: a retrospective, preliminary clinical investigation. Int J Prosthodont. 2005 Sep-Oct;18(5):371-6.
Results Reference
background
PubMed Identifier
12731596
Citation
Botelho MG. Improved design of long-span resin-bonded fixed partial dentures: three case reports. Quintessence Int. 2003 Mar;34(3):167-71.
Results Reference
background
PubMed Identifier
12652048
Citation
Botelho MG. Inhibitory effects on selected oral bacteria of antibacterial agents incorporated in a glass ionomer cement. Caries Res. 2003 Mar-Apr;37(2):108-14. doi: 10.1159/000069019.
Results Reference
background
PubMed Identifier
11203604
Citation
Botelho MG, Nor LC, Kwong HW, Kuen BS. Two-unit cantilevered resin-bonded fixed partial dentures--a retrospective, preliminary clinical investigation. Int J Prosthodont. 2000 Jan-Feb;13(1):25-8.
Results Reference
background
PubMed Identifier
33152408
Citation
Botelho MG, Yon MJY, Mak KCK, Lam WYH. A randomised controlled trial of two-unit cantilevered or three-unit fixed-movable resin-bonded fixed partial dentures replacing missing molars. J Dent. 2020 Dec;103:103519. doi: 10.1016/j.jdent.2020.103519. Epub 2020 Nov 2.
Results Reference
derived

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Novel Use of 2-unit Cantilever Resin-bonded Bridges for Replacing Missing Molar Teeth - a Randomized Clinical Trial

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