Clinical trial NCT02731703: Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study
Official title: Evaluation of Patient Satisfaction Comparing Conventional, Overdenture and Palateless Overdenture Using Guided Maxillary Implant Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jaw, Edentulous
Keywords: overdenture
overlay
implant supported
denture
dental prosthesis
maxillary
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2016-04-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UNC Graduate Prosthodontics Clinic

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Patient satisfaction OHIP 49 score
timeFrame: End of initial treatment (32 weeks) after all 4 prostheses have each been worn for 10-12 weeks
Secondary outcomes:
measure: Change in OHIP 49 score of initial edentulous condition to new interim denture
timeFrame: Initial edentulous condition to 10-12 weeks post insertion of new interim denture
measure: Change in OHIP 49 score of new interim denture to implant retained interim denture
timeFrame: Interim denture placement to 10-12 weeks post insertion final palateless implant retained overdenture
measure: Change in OHIP 49 score of final palateless implant retained overdenture
timeFrame: 10-12 weeks post insertion of final palateless implant retained overdenture
measure: Change in OHIP 49 score of final palateless implant retained overdenture-Year 1
timeFrame: 1 Year post insertion of final palateless implant retained overdenture
measure: Change in OHIP 49 score of final palateless implant retained overdenture-Year 2
timeFrame: 2 Year post insertion of final palateless implant retained overdenture
measure: Change in OHIP 49 score of final palateless implant retained overdenture-Year 3
timeFrame: 3 Year post insertion of final palateless implant retained overdenture
measure: Change in OHIP 49 score of final palateless implant retained overdenture-Year 4
timeFrame: 4 Year post insertion of final palateless implant retained overdenture
measure: Change in OHIP 49 score of final palateless implant retained overdenture-Year 5
timeFrame: 5 Year post insertion of final palateless implant retained overdenture
measure: Number of participants exhibiting soft tissue complications of final palateless implant retained overdenture
timeFrame: Immediately post insertion of final palateless implant retained overdenture through Year 5
measure: Number of participants exhibiting fit complications of final palateless implant retained overdenture
timeFrame: Immediately post insertion of final palateless implant retained overdenture through Year 5
measure: Number of participants exhibiting retention complications of final palateless implant retained overdenture
timeFrame: Immediately post insertion of final palateless implant retained overdenture through Year 5
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina School of Dentistry, Graduate Prosthodontics
state: North Carolina
Study officials:
affiliation: Associate Professor UNC School of Dentistry
name: Ingeborg De Kok, DDS MS
role: PRINCIPAL_INVESTIGATOR
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