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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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ClinicalTrials.gov Identifier: NCT02239718
Recruitment Status : Recruiting
First Posted : September 15, 2014
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Dr Michael G. Botelho, The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Missing Teeth Procedure: 2-unit cantilevered resin bonded bridge Procedure: 3-unit fixed movable resin bonded bridge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Use of 2-unit Cantilever Resin-bonded Bridges for Replacing Missing Molar Teeth - a Randomized Clinical Trial
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2-unit cantilevered resin bonded bridge
Use one tooth as abutment tooth to replace one adjacent missing tooth
Procedure: 2-unit cantilevered resin bonded bridge
Use one tooth as abutment tooth to replace one adjacent missing tooth

Active Comparator: 3-unit fixed movable resin bonded bridge
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).
Procedure: 3-unit fixed movable resin bonded bridge
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 Measures :
  1. Survival of bridges (RBB) [ Time Frame: Three years ]

    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.


  2. Drifting of abutment teeth after insertion of the bridge [ Time Frame: Three years ]

    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 :
  1. Complications [ Time Frame: Three years ]

    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


  2. Abutment mobility [ Time Frame: Three years ]
    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)

  3. Proximal contact tightness of the abutments [ Time Frame: Three years ]
    Measured with passing a dental floss and digital tension gauge on metal matrix band

  4. Oral Health related Quality of Life [ Time Frame: Three years ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239718


Contacts
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Contact: Michael G Botelho, BDS MSc PhD 28590458 botelho@hku.hk
Contact: Walter YH Lam, BDS MDS 95892076 jwalterby@yahoo.com.hk

Locations
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China, Guangdong
Department of Prosthodontics, Guanghua School of Stomatology & Affiliated Hospital of Stomatology, Sun Yat-sen University Not yet recruiting
GuangZhou, Guangdong, China
Contact: Yan Wang, BDS MDS PhD    83802805    wyan65@163.com   
Principal Investigator: Yan Wang, BDS MDS PhD         
Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong Recruiting
Hong Kong, Guangdong, China
Contact: Michael G Botelho, BDS MSc PhD       Botelho@hku.hk   
Contact: Walter YH Lam, BDS MDS       jwalterby@yahoo.com.hk   
Principal Investigator: Michael G Botelho, BDS MSc PhD         
Sub-Investigator: Edward CM Lo, BDS MDS PhD         
Sub-Investigator: Walter YH Lam, BDS MDS         
Sponsors and Collaborators
The University of Hong Kong
Sun Yat-sen University
Investigators
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Study Chair: Michael G Botelho, BDS MSc PhD Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong
Study Director: Edward CM Lo, BDS MDS PhD Dental Public Health, Faculty of Dentistry, The University of Hong Kong
Study Director: Yan Wang, BDS MDS PhD Department of Prosthodontics, Guanghua School of Stomatology, Sun Yat-sen University
Principal Investigator: Walter YH Lam, BDS MDS Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong

Publications:
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Responsible Party: Dr Michael G. Botelho, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02239718    
Other Study ID Numbers: 17100314
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Dr Michael G. Botelho, The University of Hong Kong:
Resin bonded bridges
Clinical trial
Prospective
Survival
Oral health related quality of life
Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities