NCT03224273

Brief Summary

in the last years, dentistry is going to the concept of conservatism to preserve the most amount of tooth structure, so the evolution of new ceramic materials with invasive designs like (inlay- shaped and proximal box shaped) inlay retained bridge, the investigators can restore single missing posterior teeth with less invasive techniques and less rate of restoration fracture.

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
70

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

July 18, 2017

Last Update Submit

September 10, 2017

Conditions

Keywords

proximal box design preparation

Outcome Measures

Primary Outcomes (1)

  • fracture

    resistance of restoration to disintegrate and the assessment for the outcome will be done by using MUSPHS scale and the measuring unit is score

    1 year

Study Arms (2)

( proximal box design)

EXPERIMENTAL

The proximal box at least ( 1mm wide and has 6◦ divergences, and extend 2 mm apical to the isthmus floor.

Other: proximal box inlay retained bridge

( inlay shaped design)

ACTIVE COMPARATOR

The occlusal inlay has a preparation depth of 2.0 mm for the ceramic. The occlusal preparation ( 4 mm wide and extend 4mm for premolar and 6 mm for molar mesiodistally

Other: proximal box inlay retained bridge

Interventions

inlay retained bridge is the less invasive type to restore single missing teeth in the posterior area

Also known as: all ceramic inlay retained bridge
( inlay shaped design)( proximal box design)

Eligibility Criteria

Age18 Years - 51 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Absence of periapical or periodontal or diseases
  • sound abutment teeth or with small caries or filling on occlusal or proximal surfaces
  • Maintenance of good oral hygiene
  • No tooth mobility or grade 1 can be accepted
  • Sufficient occluso-gingival tooth height (5mm)
  • Good alignment of abutment teeth
  • mesiodistal edentulous space preferred not exceed 12mm

You may not qualify if:

  • Patients under the age of 18 or being incapable of taking out a contract
  • Patients with any medical condition that impaired correct oral hygiene
  • Endodontic ally treated abutment teeth
  • a conspicuous medical or psychological history
  • bruxism, or known allergic reaction to the materials used
  • limited vertical space for the required connector height of 4mm
  • pregnant female patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth InjuriesTooth DiseasesStomatognathic DiseasesWounds and Injuries

Central Study Contacts

Gomaa Abdallah Soliman, MDS

CONTACT

Mohamed Mahmoud Abdelgawad, MDS

CONTACT

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

July 18, 2017

First Posted

July 21, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

September 12, 2017

Record last verified: 2017-09