Jaw, EdentulousNCT02731703
Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study
An observational study of Jaw, Edentulous, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study will identify and enroll patients already scheduled to receive guided maxillary implant placement with palateless overdenture. Standard clinical practice will be followed for this multi-stage process. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous
- What is being tested?
- Overdenture treatment
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 4 Jan 2023
- Phase
- Observational
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: UNC Graduate Prosthodontics Clinic
Who may be able to join
- Capable of giving informed consent
- Able and willing to follow study procedures and instructions
- In good general health
- Edentulous in maxillary arch for a period of at least 6 months
- Have adequate bone volume present to place four maxillary implants without necessity of sinus augmentation or hard and soft tissue grafting ( as determined by the investigator following panoramic radiograph acquisition)
Who cannot join
- ASA (American Society of Anesthesiologists) Class 3+
- Immunocompromised (Including HIV infection)
- Current drug abuse (self-reported as part of the School of Dentistry health history
- Pregnant or plans to be pregnant at any point during trial
- History of IV or oral bisphosphonate use contraindicating dental implant therapy
- Chronic disease with oral manifestations
Show all 11Show fewer
- Exhibit Oral pathology
- Ongoing medications initiated less than three months prior to enrollment (medications for chronic medical conditions must be initiated at least three months prior to enrollment.)
- Smoker within the past 6 months
- Diabetes
- Known allergies to any materials used in denture fabrication or implant surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina School of Dentistry, Graduate Prosthodontics
Chapel Hill, North Carolina, 27599
About this study
Official title: Evaluation of Patient Satisfaction Comparing Conventional, Overdenture and Palateless Overdenture Using Guided Maxillary Implant Placement
This study will identify and enroll patients already scheduled to receive guided maxillary implant placement with palateless overdenture. Standard clinical practice will be followed for this multi-stage process. The study purpose is to evaluate the degree of satisfaction during the standard progression in order to determine at which post edentulous stage patients achieve maximum satisfaction using the Oral Health Impact Profile 49 (OHIP 49).
Read the detailed description
The OHIP 49 will be administered at pre-treatment (edentulous condition) and after each visit (i.e., newly fabricated conventional denture, conversion to a 4 implant retained overdenture and finally a 4 implant retained palateless overdenture). Additionally they will be recalled yearly for 5 years.
Participants will have an interim denture fabricated to be worn for 10-12 weeks. During this time, participants will have 4 implants placed and continue wearing the interim denture. At 8 weeks after implant placement, participants will have locator attachments placed on implants and the interim denture snapped into place, termed the 'overdenture.' After 10-12 weeks of wearing this overdenture, patients will receive a new denture, termed 'final palateless overdenture,' which consists of a denture snapped into the 4 implants without a palate. Participants will be evaluated at a 10-12 week followup from insertion of this prosthesis. Participants will complete questionnaires at each stage of treatment.
One year after delivery of the final palateless overdenture and for five consecutive years patients will be asked to return for a follow up appointment.
Estimated duration of patient participation is approximately 5 years and 8 months (271 weeks). Estimated time for active clinical treatment is 8 months (32 weeks) with understanding of flexibility based on laboratory fabricated denture frameworks and adjustments needed for approval of esthetics.
- Conditions
- Jaw, Edentulous
- Being tested
- Overdenture treatment
- Keywords
- overdenture, overlay, implant supported, denture, dental prosthesis, maxillary
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overdenture treatmentDevice
Conventional, FDA-approved prosthetics will be used in accordance with their labeling and pre-study prescribed standard treatment approach
| Study group | Role | What they receive |
|---|---|---|
| Overdenture Treatment | Guided maxillary implant placement with palateless overdenture Receives: Device: Overdenture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Patient satisfaction OHIP 49 score
The OHIP 49 provides a measure of social impact of oral disorders by providing a comprehensive measure of dysfunction, discomfort and disability resulting from oral cavity conditions. The OHIP 49 is based on the adaptation of the World Health Organization classification. Responses on the OHIP 49 questionnaire are made on a patient satisfaction survey consisting of 49 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale.
Measured: End of initial treatment (32 weeks) after all 4 prostheses have each been worn for 10-12 weeks
Secondary outcomes (11)
Change in OHIP 49 score of initial edentulous condition to new interim denture
Participant will wear new denture for 10-12 weeks and then OHIP 49 will be administered to compare satisfaction score to their previous edentulous condition.
Measured: Initial edentulous condition to 10-12 weeks post insertion of new interim denture
Change in OHIP 49 score of new interim denture to implant retained interim denture
Participant will wear implant retained denture for 10-12 weeks and then OHIP 49 will be administered to compare satisfaction score to their previous denture without implant retention.
Measured: Interim denture placement to 10-12 weeks post insertion final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture
Participant will wear final palateless implant retained overdenture for 10-12 weeks and then OHIP 49 will be administered to compare satisfaction score to their previous denture without implant retention.
Measured: 10-12 weeks post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 1
Participant will wear final palateless implant retained overdenture for 1 year and then OHIP 49 will be administered to compare satisfaction score to their previous denture without implant retention.
Measured: 1 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 2
Participant will wear final palateless implant retained overdenture for 2 years and then OHIP 49 will be administered to compare satisfaction score to their previous denture without implant retention.
Measured: 2 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 3
Participant will wear final palateless implant retained overdenture for 3 years and then OHIP 49 will be administered to compare satisfaction score to their previous denture without implant retention.
Measured: 3 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 4
Participant will wear final palateless implant retained overdenture for 4 years and then OHIP 49 will be administered to compare satisfaction score to their previous denture without implant retention.
Measured: 4 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 5
Participant will wear final palateless implant retained overdenture for 5 years and then OHIP 49 will be administered to compare satisfaction score to their previous denture without implant retention.
Measured: 5 Year post insertion of final palateless implant retained overdenture
Number of participants exhibiting soft tissue complications of final palateless implant retained overdenture
Participant will return yearly for 5 years to evaluate possible complications in regards to health of soft tissue
Measured: Immediately post insertion of final palateless implant retained overdenture through Year 5
Number of participants exhibiting fit complications of final palateless implant retained overdenture
Participant will return yearly for 5 years to evaluate possible complications in regards to the fit of the palateless implant retained overdenture
Measured: Immediately post insertion of final palateless implant retained overdenture through Year 5
Number of participants exhibiting retention complications of final palateless implant retained overdenture
Participant will return yearly for 5 years to evaluate possible complications in regards to the retention of the palateless implant retained overdenture
Measured: Immediately post insertion of final palateless implant retained overdenture through Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion9 Aug 2017
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Jaw, EdentulousStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Sponsor
- Investigators
- Ingeborg De Kok, DDS MS, Principal investigator, Associate Professor UNC School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731703
- Sponsor's protocol ID
- 16-0521
- Status last verified
- May 2023
- First submitted
- 22 Mar 2016
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
PubMed 3527955Arisan V, Karabuda CZ, Ozdemir T. Implant surgery using bone- and mucosa-supported stereolithographic guides in totally edentulous jaws: surgical and post-operative outcomes of computer-aided vs. standard techniques. Clin Oral Implants Res. 2010 Sep;21(9):980-8. doi: 10.1111/j.1600-0501.2010.01957.x. Epub 2010 May 24.
PubMed 20497439Bragger U. Radiographic parameters: biological significance and clinical use. Periodontol 2000. 2005;39:73-90. doi: 10.1111/j.1600-0757.2005.00128.x. No abstract available.
PubMed 16135065Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period. Scand J Plast Reconstr Surg Suppl. 1977;16:1-132. No abstract available.
PubMed 356184Cardelli P, Cecchetti F, Montani M, Bramanti E, Arcuri C. Clinical assessment of submerged vs non-submerged implants placed in pristine bone. Oral Implantol (Rome). 2014 May 19;6(4):89-93. eCollection 2013 Apr.
PubMed 24971162Cavallaro JS Jr, Tarnow DP. Unsplinted implants retaining maxillary overdentures with partial palatal coverage: report of 5 consecutive cases. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):808-14.
PubMed 17974117Cranin AN, DeGrado J, Kaufman M, Baraoidan M, DiGregorio R, Batgitis G, Lee Z. Evaluation of the Periotest as a diagnostic tool for dental implants. J Oral Implantol. 1998;24(3):139-46. doi: 10.1563/1548-1336(1998)0242.3.CO;2.
PubMed 9893520Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais J, Naert I, Payne AG, Penrod J, Stoker GT, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients. Montreal, Quebec, May 24-25, 2002. Int J Oral Maxillofac Implants. 2002 Jul-Aug;17(4):601-2. No abstract available.
PubMed 12182304Fortin T, Bosson JL, Isidori M, Blanchet E. Effect of flapless surgery on pain experienced in implant placement using an image-guided system. Int J Oral Maxillofac Implants. 2006 Mar-Apr;21(2):298-304.
PubMed 16634502Fransson C, Lekholm U, Jemt T, Berglundh T. Prevalence of subjects with progressive bone loss at implants. Clin Oral Implants Res. 2005 Aug;16(4):440-6. doi: 10.1111/j.1600-0501.2005.01137.x.
PubMed 16117768Gendreau L, Loewy ZG. Epidemiology and etiology of denture stomatitis. J Prosthodont. 2011 Jun;20(4):251-60. doi: 10.1111/j.1532-849X.2011.00698.x. Epub 2011 Apr 4.
PubMed 21463383Heitz-Mayfield LJ. Peri-implant diseases: diagnosis and risk indicators. J Clin Periodontol. 2008 Sep;35(8 Suppl):292-304. doi: 10.1111/j.1600-051X.2008.01275.x.
PubMed 18724857Nilsson B. The occurrence of taste buds in the palate of human adults as evidenced by light microscopy. Acta Odontol Scand. 1979;37(5):253-8. doi: 10.3109/00016357909004694.
PubMed 294117Pjetursson BE, Asgeirsson AG, Zwahlen M, Sailer I. Improvements in implant dentistry over the last decade: comparison of survival and complication rates in older and newer publications. Int J Oral Maxillofac Implants. 2014;29 Suppl:308-24. doi: 10.11607/jomi.2014suppl.g5.2.
PubMed 24660206Roos-Jansaker AM, Lindahl C, Renvert H, Renvert S. Nine- to fourteen-year follow-up of implant treatment. Part II: presence of peri-implant lesions. J Clin Periodontol. 2006 Apr;33(4):290-5. doi: 10.1111/j.1600-051X.2006.00906.x.
PubMed 16553638
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction Comparing Conventional, Overdenture and Palateless Overdenture Using Guided Maxillary Implant Placement
- ClinicalTrials.gov ID
- NCT02731703
- Acronym / sponsor ID
- 16-0521
- Conditions
- Jaw, Edentulous
- Keywords
- overdenture, overlay, implant supported, denture, dental prosthesis, maxillary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Apr 2016 (actual)
- Primary completion
- 9 Aug 2017 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 7 Apr 2016 (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.
This study will identify and enroll patients already scheduled to receive guided maxillary implant placement with palateless overdenture. Standard clinical practice will be followed for this multi-stage process. The study purpose is to evaluate the degree of satisfaction during the standard progression in order to determine at which post edentulous stage patients achieve maximum satisfaction using the Oral Health Impact Profile 49 (OHIP 49).
Detailed description
The OHIP 49 will be administered at pre-treatment (edentulous condition) and after each visit (i.e., newly fabricated conventional denture, conversion to a 4 implant retained overdenture and finally a 4 implant retained palateless overdenture). Additionally they will be recalled yearly for 5 years.
Participants will have an interim denture fabricated to be worn for 10-12 weeks. During this time, participants will have 4 implants placed and continue wearing the interim denture. At 8 weeks after implant placement, participants will have locator attachments placed on implants and the interim denture snapped into place, termed the 'overdenture.' After 10-12 weeks of wearing this overdenture, patients will receive a new denture, termed 'final palateless overdenture,' which consists of a denture snapped into the 4 implants without a palate. Participants will be evaluated at a 10-12 week followup from insertion of this prosthesis. Participants will complete questionnaires at each stage of treatment.
One year after delivery of the final palateless overdenture and for five consecutive years patients will be asked to return for a follow up appointment.
Estimated duration of patient participation is approximately 5 years and 8 months (271 weeks). Estimated time for active clinical treatment is 8 months (32 weeks) with understanding of flexibility based on laboratory fabricated denture frameworks and adjustments needed for approval of esthetics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overdenture Treatment | – | Device: Overdenture treatmentGuided maxillary implant placement with palateless overdenture |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- UNC Graduate Prosthodontics Clinic
Key inclusion criteria (5 listed)
- Capable of giving informed consent
- Able and willing to follow study procedures and instructions
- In good general health
- Edentulous in maxillary arch for a period of at least 6 months
- Have adequate bone volume present to place four maxillary implants without necessity of sinus augmentation or hard and soft tissue grafting ( as determined by the investigator following panoramic radiograph acquisition)
Key exclusion criteria (11 listed)
- ASA (American Society of Anesthesiologists) Class 3+
- Immunocompromised (Including HIV infection)
- Current drug abuse (self-reported as part of the School of Dentistry health history
- Pregnant or plans to be pregnant at any point during trial
- History of IV or oral bisphosphonate use contraindicating dental implant therapy
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 |
|---|---|---|
| Overdenture treatmentConventional, FDA-approved prosthetics will be used in accordance with their labeling and pre-study prescribed standard treatment approach | Device | Overdenture Treatment |
Primary outcome
Overall Patient satisfaction OHIP 49 score
Time frame: End of initial treatment (32 weeks) after all 4 prostheses have each been worn for 10-12 weeks
The OHIP 49 provides a measure of social impact of oral disorders by providing a comprehensive measure of dysfunction, discomfort and disability resulting from oral cavity conditions. The OHIP 49 is based on the adaptation of the World Health Organization classification. Responses on the OHIP 49 questionnaire are made on a patient satisfaction survey consisting of 49 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale.
11 secondary outcomes
Change in OHIP 49 score of initial edentulous condition to new interim denture
Time frame: Initial edentulous condition to 10-12 weeks post insertion of new interim denture
Change in OHIP 49 score of new interim denture to implant retained interim denture
Time frame: Interim denture placement to 10-12 weeks post insertion final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture
Time frame: 10-12 weeks post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 1
Time frame: 1 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 2
Time frame: 2 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 3
Time frame: 3 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 4
Time frame: 4 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 5
Time frame: 5 Year post insertion of final palateless implant retained overdenture
Number of participants exhibiting soft tissue complications of final palateless implant retained overdenture
Time frame: Immediately post insertion of final palateless implant retained overdenture through Year 5
Number of participants exhibiting fit complications of final palateless implant retained overdenture
Time frame: Immediately post insertion of final palateless implant retained overdenture through Year 5
Number of participants exhibiting retention complications of final palateless implant retained overdenture
Time frame: Immediately post insertion of final palateless implant retained overdenture through Year 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Background: PubMed 3527955Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
- Background: PubMed 20497439Arisan V, Karabuda CZ, Ozdemir T. Implant surgery using bone- and mucosa-supported stereolithographic guides in totally edentulous jaws: surgical and post-operative outcomes of computer-aided vs. standard techniques. Clin Oral Implants Res. 2010 Sep;21(9):980-8. doi: 10.1111/j.1600-0501.2010.01957.x. Epub 2010 May 24.
- Background: PubMed 16135065Bragger U. Radiographic parameters: biological significance and clinical use. Periodontol 2000. 2005;39:73-90. doi: 10.1111/j.1600-0757.2005.00128.x. No abstract available.
- Background: PubMed 356184Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period. Scand J Plast Reconstr Surg Suppl. 1977;16:1-132. No abstract available.
- Background: PubMed 24971162Cardelli P, Cecchetti F, Montani M, Bramanti E, Arcuri C. Clinical assessment of submerged vs non-submerged implants placed in pristine bone. Oral Implantol (Rome). 2014 May 19;6(4):89-93. eCollection 2013 Apr.
- Background: PubMed 17974117Cavallaro JS Jr, Tarnow DP. Unsplinted implants retaining maxillary overdentures with partial palatal coverage: report of 5 consecutive cases. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):808-14.
- Background: PubMed 9893520Cranin AN, DeGrado J, Kaufman M, Baraoidan M, DiGregorio R, Batgitis G, Lee Z. Evaluation of the Periotest as a diagnostic tool for dental implants. J Oral Implantol. 1998;24(3):139-46. doi: 10.1563/1548-1336(1998)0242.3.CO;2.
- Background: PubMed 12182304Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais J, Naert I, Payne AG, Penrod J, Stoker GT, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients. Montreal, Quebec, May 24-25, 2002. Int J Oral Maxillofac Implants. 2002 Jul-Aug;17(4):601-2. No abstract available.
- Background: PubMed 16634502Fortin T, Bosson JL, Isidori M, Blanchet E. Effect of flapless surgery on pain experienced in implant placement using an image-guided system. Int J Oral Maxillofac Implants. 2006 Mar-Apr;21(2):298-304.
- Background: PubMed 16117768Fransson C, Lekholm U, Jemt T, Berglundh T. Prevalence of subjects with progressive bone loss at implants. Clin Oral Implants Res. 2005 Aug;16(4):440-6. doi: 10.1111/j.1600-0501.2005.01137.x.
- Background: PubMed 21463383Gendreau L, Loewy ZG. Epidemiology and etiology of denture stomatitis. J Prosthodont. 2011 Jun;20(4):251-60. doi: 10.1111/j.1532-849X.2011.00698.x. Epub 2011 Apr 4.
- Background: PubMed 18724857Heitz-Mayfield LJ. Peri-implant diseases: diagnosis and risk indicators. J Clin Periodontol. 2008 Sep;35(8 Suppl):292-304. doi: 10.1111/j.1600-051X.2008.01275.x.
- Individual participant dataSharing planned: No
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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.
Ingeborg De Kok, DDS MS principal investigator
Associate Professor UNC School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaw, Edentulous, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Patient satisfaction OHIP 49 score (time frame: End of initial treatment (32 weeks) after all 4 prostheses have each been worn for 10-12 weeks). 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 NCT02731703, which also lists 23 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 May 2023.