Satisfaction and Adaptation After Elevation of Vertical Dimension of Occlusion Using Overlay Denture or Fixed Crowns

NCT03579134 | Unknown

• 1 other identifier: amrelkammah
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Elevation of the vertical dimension of occlusion has always been a debatable issue specially using removable prosthesis. Fixed restorations have been a more predictable treatment modality in treating patients with tooth surface loss. A more conservative restoration, more retrievable, and cost effective option is proposed. Partial overlay dentures could provide a reversible and more conservative solution either by being used as a final restoration or teeth are provided with ceramic onlays instead of crowns.

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Assesment of patient satisfaction using OHIP-14 questionnaire

  comfort of the patient and satisfaction regarding function, speech, esthetics are assesed using OHIP-14 questionnaire, and assesment will be using a Likert scale. The Likert Scale is a 5 or 7 point scale that offers a range of answer options - from one extreme attitude to another, like "extremely likely" to "not at all likely." Typically, they include a moderate or neutral midpoint.

  3 months

Secondary Outcomes (1)

• adaptation

  3 months

Study Arms (2)

partial overlay denture

EXPERIMENTAL

removable partial denture with a metal extension over the remaining posterior teeth raising their height to the newly proposed vertical dimension and occlusal plane

Device: partial overlay denture

fixed temporary crowns

ACTIVE COMPARATOR

fixed crowns made from temporary material placed on the prepared posterior teeth to the new occlusal plane level elevating the vertical dimension to the newly proposed level

Other: fixed temporary crowns

Interventions

partial overlay denture DEVICE

removable appliance similar to a removable partial denture but with overlay occluslal rests covering the full occlusal surface of the remaining posterior teeth

partial overlay denture

fixed temporary crowns OTHER

fixed crowns made from temporary material placed to the newly altered vertical dimension

fixed temporary crowns

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients fully dentate or partially edentulous with medium to severe tooth surface loss
• Minimum of one existing occluding pair of posterior teeth on each side (right and left).
• Patients were class 1 skeletal relation Patients requiring elevation 2-5mm.
• Patients having compensated tooth surface loss

You may not qualify if:

• Patients not having atleast 2 occluding pairs of posterior teeth.
• Skeletal class 2 and 3.
• Edentulous patients

Sponsors & Collaborators

• Cairo University: lead

Related Publications (9)

• Abduo J. Safety of increasing vertical dimension of occlusion: a systematic review. Quintessence Int. 2012 May;43(5):369-80.

  PMID: 22536588 BACKGROUND

• Beddis HP, Durey K, Alhilou A, Chan MF. The restorative management of the deep overbite. Br Dent J. 2014 Nov;217(9):509-15. doi: 10.1038/sj.bdj.2014.953.

  PMID: 25377818 BACKGROUND

• Davies SJ, Gray RJ, Qualtrough AJ. Management of tooth surface loss. Br Dent J. 2002 Jan 12;192(1):11-6, 19-23. doi: 10.1038/sj.bdj.4801278.

  PMID: 11852896 BACKGROUND

• Faigenblum M. Removable prostheses. Br Dent J. 1999 Mar 27;186(6):273-6. doi: 10.1038/sj.bdj.4800086.

  PMID: 10230101 BACKGROUND

• Ibbetson R. Tooth surface loss. 9. Treatment planning. Br Dent J. 1999 Jun 12;186(11):552-8. doi: 10.1038/sj.bdj.4800167. No abstract available.

  PMID: 10405470 BACKGROUND

• Lambrechts P, Braem M, Vuylsteke-Wauters M, Vanherle G. Quantitative in vivo wear of human enamel. J Dent Res. 1989 Dec;68(12):1752-4. doi: 10.1177/00220345890680120601.

  PMID: 2600255 BACKGROUND

• Mehta SB, Banerji S, Millar BJ, Suarez-Feito JM. Current concepts on the management of tooth wear: part 2. Active restorative care 1: the management of localised tooth wear. Br Dent J. 2012 Jan 27;212(2):73-82. doi: 10.1038/sj.bdj.2012.48.

  PMID: 22281629 BACKGROUND

• Carlsson GE, Ingervall B, Kocak G. Effect of increasing vertical dimension on the masticatory system in subjects with natural teeth. J Prosthet Dent. 1979 Mar;41(3):284-9. doi: 10.1016/0022-3913(79)90008-8. No abstract available.

  PMID: 283228 BACKGROUND

• Gopi Chander N, Venkat R. An appraisal on increasing the occlusal vertical dimension in full occlusal rehabilitation and its outcome. J Indian Prosthodont Soc. 2011 Jun;11(2):77-81. doi: 10.1007/s13191-011-0066-9. Epub 2011 May 27.

  PMID: 22654346 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Amr H Elkammah, B.D.S

  Cairo University

  PRINCIPAL INVESTIGATOR

• Ahmed E Fayyad, P.H.D

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Amr H Elkammah, B.D.S

CONTACT

01001688382; amr-hassan@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal inverstigator

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 6, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: the use of a controlled access approach, using a transparent and robust system to review requests and provide secure data access, seeking consent for sharing IPD from participants with adequate assurance that patient privacy and confidentiality can be maintained; and establishing an approach to resource the sharing of IPD