Clinical Trial: Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary:

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).

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.

Estimated duration of patient participation is approximately 8 months (31weeks) with understanding of flexibility based on laboratory fabricated denture frameworks and adjustments needed for approval of esthetics.


Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Overall Patient satisfaction OHIP 49 score [ Time Frame: End of 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in OHIP 49 score of initial edentulous condition to new interim denture [ Time Frame: 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 [ Time Frame: Interim denture placement to 10-12 weeks post insertion 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.
  • Change in OHIP 49 score of implant retained interim denture to final palateless implant retained overdenture. [ Time Frame: Implant retained interim denture placement to 10-12 weeks post insertion final palateless implant ]
    Participants will wear palateless implant retained denture for 10-12 weeks and then OHIP 49 will be administered to compare satisfaction score to their previous implant-retained denture with a full palate.


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: March 22, 2016
Date Started: April 2016
Date Completion: March 2018
Last Updated: March 31, 2017
Last Verified: March 2017