Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study
NCT ID: NCT02731703
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
14 participants
OBSERVATIONAL
2016-04-30
2023-01-04
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Overdenture Treatment
Guided maxillary implant placement with palateless overdenture
Overdenture treatment
Conventional, FDA-approved prosthetics will be used in accordance with their labeling and pre-study prescribed standard treatment approach
Interventions
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Overdenture treatment
Conventional, FDA-approved prosthetics will be used in accordance with their labeling and pre-study prescribed standard treatment approach
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
Yes
Sponsors
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Dentsply Sirona Implants and Consumables
INDUSTRY
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Ingeborg De Kok, DDS MS
Role: PRINCIPAL_INVESTIGATOR
Associate Professor UNC School of Dentistry
Locations
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University of North Carolina School of Dentistry, Graduate Prosthodontics
Chapel Hill, North Carolina, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
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.
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.
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.
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.
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.
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.
Other Identifiers
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16-0521
Identifier Type: -
Identifier Source: org_study_id
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