Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02731703

Collaborator

Dentsply Sirona Implants (Industry)

Enrollment

Location

104

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous	Device: Overdenture treatment

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

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Aug 9, 2017

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Overdenture Treatment Guided maxillary implant placement with palateless overdenture	Device: Overdenture treatment Conventional, FDA-approved prosthetics will be used in accordance with their labeling and pre-study prescribed standard treatment approach

Arm

Intervention/Treatment

Overdenture Treatment

Guided maxillary implant placement with palateless overdenture

Device: Overdenture treatment

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

Outcome Measures

Primary Outcome Measures

Overall Patient satisfaction OHIP 49 score [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.

Secondary Outcome Measures

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]
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.
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]
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.
Change in OHIP 49 score of final palateless implant retained overdenture [10-12 weeks post insertion 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.
Change in OHIP 49 score of final palateless implant retained overdenture-Year 1 [1 Year post insertion of final palateless implant retained overdenture]
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.
Change in OHIP 49 score of final palateless implant retained overdenture-Year 2 [2 Year post insertion of final palateless implant retained overdenture]
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.
Change in OHIP 49 score of final palateless implant retained overdenture-Year 3 [3 Year post insertion of final palateless implant retained overdenture]
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.
Change in OHIP 49 score of final palateless implant retained overdenture-Year 4 [4 Year post insertion of final palateless implant retained overdenture]
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.
Change in OHIP 49 score of final palateless implant retained overdenture-Year 5 [5 Year post insertion of final palateless implant retained overdenture]
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.
Number of participants exhibiting soft tissue complications of final palateless implant retained overdenture [Immediately post insertion of final palateless implant retained overdenture through Year 5]
Participant will return yearly for 5 years to evaluate possible complications in regards to health of soft tissue
Number of participants exhibiting fit complications of final palateless implant retained overdenture [Immediately post insertion of final palateless implant retained overdenture through Year 5]
Participant will return yearly for 5 years to evaluate possible complications in regards to the fit of the palateless implant retained overdenture
Number of participants exhibiting retention complications of final palateless implant retained overdenture [Immediately post insertion of final palateless implant retained overdenture through Year 5]
Participant will return yearly for 5 years to evaluate possible complications in regards to the retention of the palateless implant retained overdenture

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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