Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study

May 12, 2023 updated by: University of North Carolina, Chapel Hill

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

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).

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina School of Dentistry, Graduate Prosthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

UNC Graduate Prosthodontics Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Patient satisfaction OHIP 49 score
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.
End of initial treatment (32 weeks) after all 4 prostheses have each been worn for 10-12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Initial edentulous condition to 10-12 weeks post insertion of new interim denture
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 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.
Interim denture placement to 10-12 weeks post insertion final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture
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.
10-12 weeks post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 1
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.
1 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 2
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.
2 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 3
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.
3 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 4
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.
4 Year post insertion of final palateless implant retained overdenture
Change in OHIP 49 score of final palateless implant retained overdenture-Year 5
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.
5 Year post insertion of final palateless implant retained overdenture
Number of participants exhibiting soft tissue complications of final 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 health of soft tissue
Immediately post insertion of final palateless implant retained overdenture through Year 5
Number of participants exhibiting fit complications of final 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 fit of the palateless implant retained overdenture
Immediately post insertion of final palateless implant retained overdenture through Year 5
Number of participants exhibiting retention complications of final 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
Immediately post insertion of final palateless implant retained overdenture through Year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Dentsply Sirona Implants and Consumables

Investigators

  • Principal Investigator: Ingeborg De Kok, DDS MS, Associate Professor UNC School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

August 9, 2017

Study Completion (Actual)

January 4, 2023

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Jaw, Edentulous

Clinical Trials on Overdenture treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe