Clinical Assessment Of Inlay Retained Bridge Designs (Tub Shaped And Inlay Shaped) In Missing Posterior Teeth Cases.

NCT03715842 | Unknown

• 1 other identifier: CEBD-CU-2018-10-08
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

The interest in partial coverage retainers such as inlays and onlays have increased drastically because these restorations are able to provide a more conservative option requiring minimal tissue removal thus preserving healthy tooth structure to a maximum extent. If patient rejects an implant treatment and enough sound tooth structure is available it would be desirable to restore a missing tooth with Inlay-Retained Fixed Partial Denture instead of full coverage retained one . The use of all-ceramic materials for inlays and onlays in restorative dentistry is becoming more popular , the proper selection of restorative materials, careful preparation design and adequate adhesion between tooth/restorative material interfaces considered important factor to prevent failures . Zirconia was introduced into dentistry in the 1990s.The high initial strength and fracture toughness of zirconia results from a physical property of partially stabilized zirconia known as transformation toughening. On the other hand, its white color, similar to the color of natural teeth and its ability to transmit light makes it useful in aesthetically important areas . Inlay Fixed Partial Denture restoration may have increased the risk of fracture due to the relative small size of restorations compared to the complete coverage restoration. An unfavorable distribution of stresses between the ceramic inlay and tooth structure may result in marginal deterioration around the inlay or its failure. The direction of forces on the occlusal surface of Inlay Fixed Partial Denture may lead to the phenomenon of submargination, ceramic fracture, wear at interface and postoperative hypersensitivity which remain a problem that require further investigation. One of the most important factors in the success and longevity of a restoration is to have an accurate marginal fit. Ideally, the cemented restoration should precisely meet the finish line of the prepared tooth. In reality, clinical perfection is challenging to achieve and to verify.

Conditions

Missing Tooth

Outcome Measures

Primary Outcomes (1)

• Fracture

  Fracture assessed by modified Ryge Criteria ( Alpha , Bravo , Charlie and Delta )

  one year

Study Arms (2)

Tub shaped design

EXPERIMENTAL

The tub-shaped preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished.

Other: Tub shaped design

Inlay shaped design

ACTIVE COMPARATOR

The occlusal inlay had a preparation depth that allowed a thickness of 2.0 mm for the ceramic. The occlusal preparation was 4 mm wide and extended 4 or 6 mm mesio-distally for the premolar or molar models, respectively. The proximal box was 1 mm wide and had approximately 5˚ divergence, extending 2 mm apical to the isthmus floor . The preparations corresponded to a proximal connector area of 3 mm × 3 mm for molars and premolars.

Other: Inlay shaped design

Interventions

Tub shaped design OTHER

The tub-shaped inlay preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished.

Tub shaped design

Inlay shaped design OTHER

The occlusal inlay had a preparation depth that allowed a thickness of 2.0 mm for the ceramic. The occlusal preparation was 4 mm wide and extended 4 or 6 mm mesio-distally for the premolar or molar models, respectively. The proximal box was 1 mm wide and had approximately 5˚ divergence, extending 2 mm apical to the isthmus floor . The preparations corresponded to a proximal connector area of 3 mm × 3 mm for molars and premolars.

Inlay shaped design

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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).
• Good oral hygiene
• Low susceptibility to decay
• Have a minimum coronal tooth height of 5 mm,
• Parallel abutments
• Sufficient mesio distal edentulous gap dimensions.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.

  PMID: 22821429 BACKGROUND

• Shillingburg, H.T., Hobo, S. and Whitsett, L. (1997) Fundamentals of fixed prosthodontics. 3rd Edition, Quintessence, Chicago, 119-137, 171-174.

  BACKGROUND

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 23, 2018
• Study Start: March 11, 2019
• Primary Completion: March 11, 2020
• Study Completion: April 11, 2020
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share