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NCT Number: NCT02239718

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

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.

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Key information

Conditions

Missing Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Prosthodontics, Guanghua School of Stomatology & Affiliated Hospital of Stomatology, Sun Yat-sen University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2-unit cantilevered resin bonded bridge

Procedure

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

3-unit fixed movable resin bonded bridge

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Sun Yat-sen University

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 15, 2014
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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