NCT03139396

Brief Summary

Patients with missing back teeth can be restored with an inlay retained bridge.The inlay retained bridge designs include inlay shaped, tub shaped or proximal box shaped.In this study a clinical evaluation will be commenced to evaluate two designs the inlay shaped and the tub shaped.The hypothesis of our trial is that the new design may show longer survival rate due to less stress applied on the restoration which allow the restoration to function for longer period as the inlay shaped bridge showed clinical problems during survice.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

April 30, 2017

Last Update Submit

May 3, 2017

Conditions

Tooth Loss

Keywords

inlay bridge, tub shaped design

Outcome Measures

Primary Outcomes (1)

  • Retention

    assess the loss of the restoration (debonding) the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)

    1 year

Secondary Outcomes (4)

  • marginal adaptation

    1 year

  • Caries

    1 year

  • gingivitis

    1 year

  • fracture

    1 year

Study Arms (2)

inlay shaped inlay bridge design

ACTIVE COMPARATOR

The inlay shaped inlay bridge design preparation show three types of preparation, the inlay shaped, the tub shaped inlay bridge design and the proximal box shaped designs. Intracoronal preparation of the inlay retained prosthesis for the abutments (inlay shaped and tub shaped) should show the following criteria: The inlay shaped preparation should show an occlusal-proximal box preparation and to be designed with the line angles should be rounded, smooth and rounded corners, and rectangular flat floor with no beveling for the occlusal and gingival margins. The occlusal inlay preparation should have preparation depth allowed for a thickness of 2.0 mm for the material of the bridge. The occlusal reduction show 4 mm width with extension of 4 or 6 mm mesio distally for the posterior teeth.

Procedure: tub shaped inlay bridge design

tub shaped inlay bridge design

EXPERIMENTAL

The tub-shaped reduction consist of an occlusal proximal inlay and prepared as the same geometry as the inlay shaped preparation, except that for the proximal box preparation which is not present in this preparation design.

Procedure: tub shaped inlay bridge design

Interventions

tub shaped inlay bridge designPROCEDURE

inlay retained bridge with tub shaped retainer on both abutments

Also known as: tub shaped
inlay shaped inlay bridge designtub shaped inlay bridge design

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • From 18-55 years old, should be able to read and sign the consent document.
  • Ability to tolerate the restorative procedures (physical and psychological).
  • Patients with teeth problems indicated for inlay retained fixed partial denture:
  • Good oral hygiene
  • Low susceptibility to decay
  • Have a minimum coronal tooth height of 5 mm,
  • Parallel abutments
  • Sufficient mesio distal edentulous gap dimensions.
  • With no active periodontal or pulpal problems, with sound teeth or teeth with shallow restorations
  • Willing to return for follow-up visits.

You may not qualify if:

  • Partially erupted teeth (young)
  • Bad oral hygiene and motivation
  • Root canal treated teeth
  • Psychiatric problems or unrealistic expectations
  • Severe parafunctional habits
  • The absence of enamel on the preparation margins
  • Extensive crown defects
  • Abutment mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Izgi AD, Kale E, Eskimez S. A prospective cohort study on cast-metal slot-retained resin-bonded fixed dental prostheses in single missing first molar cases: results after up to 7.5 years. J Adhes Dent. 2013 Feb;15(1):73-84. doi: 10.3290/j.jad.a29010.

    PMID: 23534027BACKGROUND

  • Ohlmann B, Rammelsberg P, Schmitter M, Schwarz S, Gabbert O. All-ceramic inlay-retained fixed partial dentures: preliminary results from a clinical study. J Dent. 2008 Sep;36(9):692-6. doi: 10.1016/j.jdent.2008.04.017. Epub 2008 Jun 11.

    PMID: 18550253BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Central Study Contacts

Mohamed Mahmoud Abdelfattah, MDS

CONTACT

00201221583708mohamed.abdelgawad@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

April 30, 2017

First Posted

May 4, 2017

Study Start

December 1, 2017

Primary Completion

February 1, 2019

Study Completion

April 1, 2019

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share