Improving Oral Health Function With Implant Supported Partial Dentures

NCT02590861 | Withdrawn

• 1 other identifier: 1510M78701
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Distal extension Partial Removable Dental Prostheses (PRDPs) are less stable than tooth supported PRDPs due to progressive resorption of the alveolar ridge, which alters the retention and support generated by alveolar bone height. In addition, long-term wearers suffer with progressive alveolar ridge resorption that contributes to greater instability. The loss of stability and retention under the PRDP can lead to difficulties during mastication and swallowing, because of movement of the partial denture. These difficulties force patients to self-select food substances that are softer and easier to chew and possibly create changes in social eating. Therefore, having a partial denture that is poorly retentive will impact their oral health related quality of life Oral Health Related Quality of Life (OHRQoL). The placement of a dental implant into the edentulous area will transform a conventional PRDP into an Implant Supported PRDP, which will improve the functional capacity of partial denture wearers, especially their ability to comminute harder food substances such as fruits and nuts. The purpose of this study is to quantitatively measure the functional differences of patients wearing conventional PRDP with patients wearing implant supported PRDPs and Oral Health Impact of patients wearing implant supported PRDPs. The hypothesis is that patient wearing implant supported PRDPs will have greater functional capacity than patients wearing conventional PRDPs.

Conditions

Partial Edentulism

Keywords

Partial Dentures; Dental Implants; Quality of Life; Partial Edentulism

Outcome Measures

Primary Outcomes (1)

• The number of participants with improved chewing function due to implant placement using Oral Health Impact Profile (OHIP)

  The patient's chewing ability will be evaluated at 1-month, 2-month, 6-month, and 12-month recall appointments to evaluate patient satisfaction.The Oral Health Related Quality of life will be measured using the OHIP\_14 instrument at the baseline, 1-month, 6-month, and 12-month recall appointment.

  1-month, 2-month, 6-month, and 12-month

Study Arms (1)

Dental implant

EXPERIMENTAL

All participants will receive the same intervention, this is a single group study.

Procedure: Dental implant

Interventions

Dental implant PROCEDURE

All participants will receive the same intervention, this is a single group study.

Dental implant

Eligibility Criteria

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

You may qualify if:

• posterior mandibular edentulism (on at least one side of the arch),
• age 18-65,
• general good health (self-reported),
• a minimum of six mandibular anterior teeth remaining,
• moderate to good periodontal health,
• speak and read English at a high school level,
• psychologically able to receive treatment.

You may not qualify if:

• smokers,
• poorly controlled diabetics,
• untreated caries,
• participants needing more than two crowns to support prosthesis,
• symptomatic TMD,
• cognitive impairment,
• diagnosis of psychiatric disorder,
• less than 25 mm interarch space,
• lingual tori,
• vertical bone height less than 10 mm,
• Class II and Class III maxillomandibular relationship,
• posterior bite collapse,
• loss of vertical dimension,
• Lekholm/Zarb grade C or more,
• Lekholm/Zarb grade 3 or more,

Sponsors & Collaborators

• University of Minnesota: lead

Related Publications (14)

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  PMID: 3891805 BACKGROUND

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  PMID: 11807476 BACKGROUND

• U.S. Bureau of the Census, Statistical Abstract of the United States: 1996. 116th ed. Washington, DC,; 1996. P15, Table II, No. 14.

  BACKGROUND

• Cooper LF. The current and future treatment of edentulism. J Prosthodont. 2009 Feb;18(2):116-22. doi: 10.1111/j.1532-849X.2009.00441.x.

  PMID: 19254301 BACKGROUND

• Douglass CW, Watson AJ. Future needs for fixed and removable partial dentures in the United States. J Prosthet Dent. 2002 Jan;87(1):9-14. doi: 10.1067/mpr.2002.121204.

  PMID: 11807477 BACKGROUND

• Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

  PMID: 9332805 BACKGROUND

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  PMID: 15849587 BACKGROUND

• McKenna G, Allen F, Woods N, O'Mahony D, Cronin M, DaMata C, Normand C. Cost-effectiveness of tooth replacement strategies for partially dentate elderly: a randomized controlled clinical trial. Community Dent Oral Epidemiol. 2014 Aug;42(4):366-74. doi: 10.1111/cdoe.12085. Epub 2013 Nov 20.

  PMID: 24251386 BACKGROUND

• Thomason JM, Kelly SA, Bendkowski A, Ellis JS. Two implant retained overdentures--a review of the literature supporting the McGill and York consensus statements. J Dent. 2012 Jan;40(1):22-34. doi: 10.1016/j.jdent.2011.08.017. Epub 2011 Sep 3.

  PMID: 21911034 BACKGROUND

• Hamdan NM, Gray-Donald K, Awad MA, Johnson-Down L, Wollin S, Feine JS. Do implant overdentures improve dietary intake? A randomized clinical trial. J Dent Res. 2013 Dec;92(12 Suppl):146S-53S. doi: 10.1177/0022034513504948. Epub 2013 Oct 24.

  PMID: 24158335 BACKGROUND

• Al-Imam H, Ozhayat EB, Benetti AR, Pedersen AM, Gotfredsen K. Oral health-related quality of life and complications after treatment with partial removable dental prosthesis. J Oral Rehabil. 2016 Jan;43(1):23-30. doi: 10.1111/joor.12338. Epub 2015 Aug 13.

  PMID: 26268721 BACKGROUND

• Fueki K, Igarashi Y, Maeda Y, Baba K, Koyano K, Sasaki K, Akagawa Y, Kuboki T, Kasugai S, Garrett NR. Effect of prosthetic restoration on oral health-related quality of life in patients with shortened dental arches: a multicentre study. J Oral Rehabil. 2015 Sep;42(9):701-8. doi: 10.1111/joor.12297. Epub 2015 Mar 25.

  PMID: 25818656 BACKGROUND

• Shaghaghian S, Taghva M, Abduo J, Bagheri R. Oral health-related quality of life of removable partial denture wearers and related factors. J Oral Rehabil. 2015 Jan;42(1):40-8. doi: 10.1111/joor.12221. Epub 2014 Aug 21.

  PMID: 25146999 BACKGROUND

• Visscher CM, Lobbezoo F, Schuller AA. Dental status and oral health-related quality of life. A population-based study. J Oral Rehabil. 2014 Jun;41(6):416-22. doi: 10.1111/joor.12167. Epub 2014 Apr 4.

  PMID: 24698541 BACKGROUND

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Keith Mays, DDS, MS, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 29, 2015
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: March 15, 2019

Record last verified: 2019-03