A Full-Arch Implant- Supported Prosthesis in the Upper and/or Lower Jaw-USA

NCT03655990 | Terminated

• 1 other identifier: JUV17-08
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study follows subjects who have agreed with their dentist that their failing teeth or missing teeth all need replacing. This study follows their standard routine care with some additional assessments. The dental treatment option that replaces a whole arch or both arches (upper and lower jaws) of the mouth is call "Teeth in a Day" and information on the use of the JUVORA™ Dental Disc during this treatment is what is being collected as part of this study along with subjects follow-up care.

Conditions

Missing Teeth

Keywords

Dentures Implant

Outcome Measures

Primary Outcomes (1)

• Survival of the Prosthetic

  Survival will be evaluated using the ITI Treatment Guide Volume 8 - Survival is defined as "is the prosthesis present in the mouth at the time of assessment ("presence or absence")

  12 months

Secondary Outcomes (16)

• Patient quality of life assessment using a patient questionnaire.

  6 weeks 6 & 12 months

• Oral and dental:Patients will be assessed for a history of Bruxism (grinding of the teeth).

  6 weeks 6 &12 months

• Oral and dental: Patients will be checked for occlusion.

  6 weeks &12 months

• Survival of the implant in the patients mouth.

  12 months

• Success of the implant in the patients mouth.

  12 months

Other Outcomes (1)

• Technical Satisfaction not related to the patient

  between 4 - 6 months prior to fixture in the patients mouth.

Study Arms (1)

Treatment with the JUVORA™ Dental Disc

Subjects receive the device as per normal standard practice, there are no other treatment arms for this prospective study.

Device: Treatment with the JUVORA™ Dental Disc

Interventions

Treatment with the JUVORA™ Dental Disc DEVICE

treatment with the JUVORA™ Dental Disc

Treatment with the JUVORA™ Dental Disc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated to receive a full-arch implant-supported prosthesis in a single jaw (mandibular or maxillary) or full-arch implant-supported prosthesis in both jaws (mandibular and maxillary).

You may qualify if:

• Subjects aged 18 years or older in need of a full-arch implant supported rehabilitation in a single jaw (mandibular or maxillary) or both edentulous jaws (mandibular and maxillary).
• Subjects with adequate bone quality and quantity to allow the placement of a minimum of four Neodent implants into the arch area.
• Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups.
• Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.

You may not qualify if:

• Female subjects who are pregnant or lactating.
• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
• Subjects with any condition that would compromise their participation and follow-up in this clinical study.
• Subjects with insufficient bone volume or quality in the edentulous jaw.
• Subjects on any chemotherapeutic or bisphosphonate medications.
• Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than 2 years.
• Subjects who smoke more than 10 cigarettes per day.
• Subjects who are currently enrolled in another clinical study.

Sponsors & Collaborators

• Juvora Ltd.: lead
• PCG Clinical Services: collaborator

Study Sites (1)

Dr Robert Lemke

San Antonio, Texas, 78216, United States

Location

Related Links

• Study location web site for enquiries

MeSH Terms

Conditions

Anodontia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Juvora

  Juvora Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: September 4, 2018
• Study Start: August 7, 2018
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)