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

NCT02239718 | Completed

• 1 other identifier: 17100314
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Missing Teeth

Keywords

Resin bonded bridges; Clinical trial; Prospective; Survival; Oral health related quality of life

Outcome Measures

Primary Outcomes (2)

• 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.

  Three years

• 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)

  Three years

Secondary Outcomes (4)

• Complications

  Three years

• Abutment mobility

  Three years

• Proximal contact tightness of the abutments

  Three years

• Oral Health related Quality of Life

  Three years

Study Arms (2)

2-unit cantilevered resin bonded bridge

EXPERIMENTAL

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

Procedure: 2-unit cantilevered resin bonded bridge

3-unit fixed movable resin bonded bridge

ACTIVE COMPARATOR

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

Interventions

2-unit cantilevered resin bonded bridge PROCEDURE

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

2-unit cantilevered resin bonded bridge

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).

3-unit fixed movable resin bonded bridge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Sun Yat-sen University: collaborator

Study Sites (2)

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

Guangzhou, Guangdong, China

Location

Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong

Hong Kong, Guangdong, China

Location

Related Publications (8)

• 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.

  PMID: 24685984 BACKGROUND

• 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.

  PMID: 23025467 BACKGROUND

• 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.

  PMID: 16803807 BACKGROUND

• 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.

  PMID: 16220800 BACKGROUND

• Botelho MG. Improved design of long-span resin-bonded fixed partial dentures: three case reports. Quintessence Int. 2003 Mar;34(3):167-71.

  PMID: 12731596 BACKGROUND

• 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.

  PMID: 12652048 BACKGROUND

• 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.

  PMID: 11203604 BACKGROUND

• 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.

  PMID: 33152408 DERIVED

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael G Botelho, BDS MSc PhD

  Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Walter YH Lam, BDS MDS

  Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 15, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

CN (2)