Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 8/8/2018 |
| Start Date: | April 2016 |
| End Date: | December 2024 |
| Contact: | Gidgetta Jenkins |
| Email: | gidget_jenkins@unc.edu |
| Phone: | 919-537-3968 |
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).
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).
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.
(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.
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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Principal Investigator: Ingeborg De Kok, DDS MS
Phone: 919-537-3968
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