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| Name | Class |
|---|---|
| Dentsply Sirona Implants and Consumables | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overdenture Treatment | Guided maxillary implant placement with palateless overdenture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overdenture treatment | Device | Conventional, FDA-approved prosthetics will be used in accordance with their labeling and pre-study prescribed standard treatment approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of initial treatment (32 weeks) after all 4 prostheses have each been worn for 10-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Initial edentulous condition to 10-12 weeks post insertion of new interim denture |
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Inclusion Criteria:
Exclusion Criteria:
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UNC Graduate Prosthodontics Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Ingeborg De Kok, DDS MS | Associate Professor UNC School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina School of Dentistry, Graduate Prosthodontics | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3527955 | Background | 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. | |
| 20497439 | Background | Arisan 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. |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | Immediately post insertion of final palateless implant retained overdenture through Year 5 |
| 16135065 | Background | Bragger 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. |
| 356184 | Background | Branemark 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. |
| 24971162 | Background | Cardelli 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. |
| 17974117 | Background | Cavallaro 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. |
| 9893520 | Background | Cranin 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. |
| 12182304 | Background | Feine 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. |
| 16634502 | Background | Fortin 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. |
| 16117768 | Background | Fransson 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. |
| 21463383 | Background | Gendreau 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. |
| 18724857 | Background | Heitz-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. |
| 294117 | Background | Nilsson 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. |
| 24660206 | Background | Pjetursson 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. |
| 16553638 | Background | Roos-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. |
| 25864962 | Background | Santos BF, dos Santos MB, Santos JF, Marchini L. Patients' Evaluations of Complete Denture Therapy and Their Association with Related Variables: A Pilot Study. J Prosthodont. 2015 Jul;24(5):351-7. doi: 10.1111/jopr.12286. Epub 2015 Apr 9. |
| 8193981 | Background | Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11. |
| 24460748 | Background | Vercruyssen M, Cox C, Coucke W, Naert I, Jacobs R, Quirynen M. A randomized clinical trial comparing guided implant surgery (bone- or mucosa-supported) with mental navigation or the use of a pilot-drill template. J Clin Periodontol. 2014 Jul;41(7):717-23. doi: 10.1111/jcpe.12231. Epub 2014 Apr 10. |
| 25810348 | Background | Wang F, Monje A, Huang W, Zhang Z, Wang G, Wu Y. Maxillary Four Implant-retained Overdentures via Locator(R) Attachment: Intermediate-term Results from a Retrospective Study. Clin Implant Dent Relat Res. 2016 Jun;18(3):571-9. doi: 10.1111/cid.12335. Epub 2015 Mar 23. |
| 23899103 | Background | Zembic A, Tahmaseb A, Wismeijer D. Within-Subject Comparison of Maxillary Implant-Supported Overdentures with and without Palatal Coverage. Clin Implant Dent Relat Res. 2015 Jun;17(3):570-9. doi: 10.1111/cid.12125. Epub 2013 Jul 30. |
| 18724856 | Background | Zitzmann NU, Berglundh T. Definition and prevalence of peri-implant diseases. J Clin Periodontol. 2008 Sep;35(8 Suppl):286-91. doi: 10.1111/j.1600-051X.2008.01274.x. |
| 10756293 | Background | Zitzmann NU, Marinello CP. Treatment outcomes of fixed or removable implant-supported prostheses in the edentulous maxilla. Part II: clinical findings. J Prosthet Dent. 2000 Apr;83(4):434-42. doi: 10.1016/s0022-3913(00)70038-2. |
| 9274079 | Background | Roos J, Sennerby L, Lekholm U, Jemt T, Grondahl K, Albrektsson T. A qualitative and quantitative method for evaluating implant success: a 5-year retrospective analysis of the Branemark implant. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):504-14. |
| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |