University of North Carolina School of Dentistry, Graduate Prosthodontics
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT02731703
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).
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Notify Me18 year–99 year
All sexes
Observational
Chapel Hill, North Carolina, 27599, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional, FDA-approved prosthetics will be used in accordance with their labeling and pre-study prescribed standard treatment approach
Time frame: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
University of North Carolina, Chapel Hill
Other
Evaluation of Patient Satisfaction Comparing Conventional, Overdenture and Palateless Overdenture Using Guided Maxillary Implant Placement
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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