Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study

NCT02731703 | Completed

• 1 other identifier: 16-0521
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Jaw, Edentulous

Keywords

overdenture; overlay; implant supported; denture; dental prosthesis; maxillary

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Change in OHIP 49 score of initial edentulous condition to new interim denture

  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

  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

  10-12 weeks post insertion of final palateless implant retained overdenture

• Change in OHIP 49 score of final palateless implant retained overdenture-Year 1

  1 Year post insertion of final palateless implant retained overdenture

• Change in OHIP 49 score of final palateless implant retained overdenture-Year 2

  2 Year post insertion of final palateless implant retained overdenture

Study Arms (1)

Overdenture Treatment

Guided maxillary implant placement with palateless overdenture

Device: Overdenture treatment

Interventions

Overdenture treatment DEVICE

Conventional, FDA-approved prosthetics will be used in accordance with their labeling and pre-study prescribed standard treatment approach

Overdenture Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UNC Graduate Prosthodontics Clinic

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Dentsply Sirona Implants and Consumables: collaborator

Study Sites (1)

University of North Carolina School of Dentistry, Graduate Prosthodontics

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (23)

• 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.

  PMID: 3527955 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.

  PMID: 20497439 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.

  PMID: 16135065 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.

  PMID: 356184 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.

  PMID: 24971162 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.

  PMID: 17974117 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.

  PMID: 9893520 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.

  PMID: 12182304 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.

  PMID: 16634502 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.

  PMID: 16117768 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.

  PMID: 21463383 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.

  PMID: 18724857 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.

  PMID: 294117 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.

  PMID: 24660206 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.

  PMID: 16553638 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.

  PMID: 25864962 BACKGROUND

• Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.

  PMID: 8193981 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.

  PMID: 24460748 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.

  PMID: 25810348 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.

  PMID: 23899103 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.

  PMID: 18724856 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.

  PMID: 10756293 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.

  PMID: 9274079 BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Ingeborg De Kok, DDS MS

  Associate Professor UNC School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 7, 2016
• Study Start: April 1, 2016
• Primary Completion: August 9, 2017
• Study Completion: January 4, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)