Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study

Jaw, Edentulous Clinical Trial

Official title:

Evaluation of Patient Satisfaction Comparing Conventional, Overdenture and Palateless Overdenture Using Guided Maxillary Implant Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731703
• Other study ID #: 16-0521
• Status: Completed
• Start date: April 2016
• Est. completion date: January 4, 2023

Study information

• Verified date: May 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 4, 2023
• Est. primary completion date: August 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Jaw, Edentulous

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina School of Dentistry, Graduate Prosthodontics	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Dentsply Sirona Implants and Consumables

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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