Partial EdentulismNCT02590861
Improving Oral Health Function With Implant Supported Partial Dentures
A study testing Dental implant in people with Partial Edentulism, run by University of Minnesota.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- Dental implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria
- 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.
Who cannot join
- The exclusion criteria
- smokers,
- poorly controlled diabetics,
- untreated caries,
- participants needing more than two crowns to support prosthesis,
- symptomatic TMD,
Show all 17Show fewer
- 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,
- the principle investigator decision.
About this study
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.
Read the detailed description
In the past few decades there has been predictions regarding the level of edentulism, and the need for prosthetic rehabilitation of the population. Although studies estimate a decline in the percentage of edentulism, and a decreased need for removable prostheses, this is predicted to be offset by a projected 79% increase in the population that is 55 years or older, the number of individuals with existing prostheses needing new prostheses and maintenance, and the professional and public health responsibility to serve this population regardless to the level of edentulism. In spite of these demographic predictions, the need for prosthodontics services, both fixed dental prostheses and removable dental prostheses will continue to an oral health concern, in part due to the an aging population that retains more of their teeth resulting in partial edentulism.
Prosthetic rehabilitation should not only replace missing teeth, but it should restore oral function and have a positive impact on Oral-Health-Related Quality of Life (OHRQoL) of our patients. As the population continues to age worldwide, and the U.S. specifically, it will become increasingly important to improve the OHRQoL for the segment of our population possessing removable prostheses with high stability, and highly retentive prosthetic services. Traditionally, both complete and partial removable dentures lack retention and stability, and one recommendation to improve the function has been to utilize dental implants to retain and stabilize the prosthesis. Although, several investigations have evaluated the OHRQoL patients wearing removable the preponderate emphasis of these studies has been on complete denture patients. In addition, OHRQoL studies are generated by patient self-reports, and limited evaluation of actual oral function has been compared to the patient self-reported function. This study will use the OHIP to evaluate the OHRQoL of patients with distal extension partial dentures, as well as, actually measure the patients chewing ability.
This prospective cohort study is designed to gather preliminary data on the improvement of patient satisfaction and oral function for individuals wearing distal extension partial dentures that are supported by smaller length dental implants. Thirty healthy male and female participants aged 18 to 65 will be treated at the University of Minnesota Dental School, in the Clinical Research Center. A lower partial denture will be fabricated using routine prosthodontic techniques. The participants will receive a 7 mm X 3.75 mm or a 8.5 mm X 4.1 mm tapered implant, A Locator Abutment will be used to connect the denture to the implant to improve the retention and stability of the partial denture. The chewing ability and chewing pattern will be evaluated with a jaw-tracking device and the masticatory muscle activity will be evaluated with surface Electromyography (EMG). OHRQoL, chewing function, and patient satisfaction will be measured at the 1, 2, 6, and 12-month recall appointments.
- Conditions
- Partial Edentulism
- Being tested
- Dental implant
- Keywords
- Partial Dentures, Dental Implants, Quality of Life, Partial Edentulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantProcedure or surgery
All participants will receive the same intervention, this is a single group study.
| Study group | Role | What they receive |
|---|---|---|
| Dental implant | Experimental | All participants will receive the same intervention, this is a single group study. Receives: Procedure: Dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-month, 2-month, 6-month, and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: Internal staffing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Partial EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Mays, DDS, MS, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590861
- Sponsor's protocol ID
- 1510M78701
- Status last verified
- Mar 2019
- First submitted
- 20 Oct 2015
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Weintraub JA, Burt BA. Oral health status in the United States: tooth loss and edentulism. J Dent Educ. 1985 Jun;49(6):368-78. No abstract available.
PubMed 3891805Douglass CW, Shih A, Ostry L. Will there be a need for complete dentures in the United States in 2020? J Prosthet Dent. 2002 Jan;87(1):5-8. doi: 10.1067/mpr.2002.121203.
PubMed 11807476U.S. Bureau of the Census, Statistical Abstract of the United States: 1996. 116th ed. Washington, DC,; 1996. P15, Table II, No. 14.
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.
PubMed 19254301Douglass 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.
PubMed 11807477Slade 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.
PubMed 9332805Slade GD, Nuttall N, Sanders AE, Steele JG, Allen PF, Lahti S. Impacts of oral disorders in the United Kingdom and Australia. Br Dent J. 2005 Apr 23;198(8):489-93; discussion 483. doi: 10.1038/sj.bdj.4812252.
PubMed 15849587McKenna 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.
PubMed 24251386Thomason 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.
PubMed 21911034Hamdan 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.
PubMed 24158335Al-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.
PubMed 26268721Fueki 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.
PubMed 25818656Shaghaghian 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.
PubMed 25146999Visscher 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.
PubMed 24698541
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Oral Health Function With Implant Supported Partial Dentures
- ClinicalTrials.gov ID
- NCT02590861
- Acronym / sponsor ID
- 1510M78701
- Conditions
- Partial Edentulism
- Keywords
- Partial Dentures, Dental Implants, Quality of Life, Partial Edentulism
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal staffing issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the past few decades there has been predictions regarding the level of edentulism, and the need for prosthetic rehabilitation of the population. Although studies estimate a decline in the percentage of edentulism, and a decreased need for removable prostheses, this is predicted to be offset by a projected 79% increase in the population that is 55 years or older, the number of individuals with existing prostheses needing new prostheses and maintenance, and the professional and public health responsibility to serve this population regardless to the level of edentulism. In spite of these demographic predictions, the need for prosthodontics services, both fixed dental prostheses and removable dental prostheses will continue to an oral health concern, in part due to the an aging population that retains more of their teeth resulting in partial edentulism.
Prosthetic rehabilitation should not only replace missing teeth, but it should restore oral function and have a positive impact on Oral-Health-Related Quality of Life (OHRQoL) of our patients. As the population continues to age worldwide, and the U.S. specifically, it will become increasingly important to improve the OHRQoL for the segment of our population possessing removable prostheses with high stability, and highly retentive prosthetic services. Traditionally, both complete and partial removable dentures lack retention and stability, and one recommendation to improve the function has been to utilize dental implants to retain and stabilize the prosthesis. Although, several investigations have evaluated the OHRQoL patients wearing removable the preponderate emphasis of these studies has been on complete denture patients. In addition, OHRQoL studies are generated by patient self-reports, and limited evaluation of actual oral function has been compared to the patient self-reported function. This study will use the OHIP to evaluate the OHRQoL of patients with distal extension partial dentures, as well as, actually measure the patients chewing ability.
This prospective cohort study is designed to gather preliminary data on the improvement of patient satisfaction and oral function for individuals wearing distal extension partial dentures that are supported by smaller length dental implants. Thirty healthy male and female participants aged 18 to 65 will be treated at the University of Minnesota Dental School, in the Clinical Research Center. A lower partial denture will be fabricated using routine prosthodontic techniques. The participants will receive a 7 mm X 3.75 mm or a 8.5 mm X 4.1 mm tapered implant, A Locator Abutment will be used to connect the denture to the implant to improve the retention and stability of the partial denture. The chewing ability and chewing pattern will be evaluated with a jaw-tracking device and the masticatory muscle activity will be evaluated with surface Electromyography (EMG). OHRQoL, chewing function, and patient satisfaction will be measured at the 1, 2, 6, and 12-month recall appointments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental implant | Experimental | Procedure: Dental implantAll participants will receive the same intervention, this is a single group study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The inclusion criteria
- 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,
Key exclusion criteria (17 listed)
- The exclusion criteria
- smokers,
- poorly controlled diabetics,
- untreated caries,
- participants needing more than two crowns to support prosthesis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implantAll participants will receive the same intervention, this is a single group study. | Procedure or surgery | Dental implant |
Primary outcome
The number of participants with improved chewing function due to implant placement using Oral Health Impact Profile (OHIP)
Time frame: 1-month, 2-month, 6-month, and 12-month
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Background: PubMed 3891805Weintraub JA, Burt BA. Oral health status in the United States: tooth loss and edentulism. J Dent Educ. 1985 Jun;49(6):368-78. No abstract available.
- Background: PubMed 11807476Douglass CW, Shih A, Ostry L. Will there be a need for complete dentures in the United States in 2020? J Prosthet Dent. 2002 Jan;87(1):5-8. doi: 10.1067/mpr.2002.121203.
- BackgroundU.S. Bureau of the Census, Statistical Abstract of the United States: 1996. 116th ed. Washington, DC,; 1996. P15, Table II, No. 14.
- Background: PubMed 19254301Cooper 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.
- Background: PubMed 11807477Douglass 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.
- Background: PubMed 9332805Slade 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.
- Background: PubMed 15849587Slade GD, Nuttall N, Sanders AE, Steele JG, Allen PF, Lahti S. Impacts of oral disorders in the United Kingdom and Australia. Br Dent J. 2005 Apr 23;198(8):489-93; discussion 483. doi: 10.1038/sj.bdj.4812252.
- Background: PubMed 24251386McKenna 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.
- Background: PubMed 21911034Thomason 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.
- Background: PubMed 24158335Hamdan 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.
- Background: PubMed 26268721Al-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.
- Background: PubMed 25818656Fueki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Mays, DDS, MS, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant in people with Partial Edentulism, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with improved chewing function due to implant placement using Oral Health Impact Profile (OHIP) (time frame: 1-month, 2-month, 6-month, and 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590861, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.