Posterior Implant-Supported Modified Monolithic Zirconia and Metal-Ceramic Single Crowns: 5 Years… (NCT04355325) | Clinical Trial Compass
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Posterior Implant-Supported Modified Monolithic Zirconia and Metal-Ceramic Single Crowns: 5 Years Study
Jordan60 participantsStarted 2020-04-02
Plain-language summary
The outcome of implant therapy has been presented in the majority of clinical studies by focusing only on implant survival without providing detailed information on the reconstructions . However, for decision making, it is important to know the survival rates and the incidence of biological and technical complications not only for the implants but also for the reconstructions. Thus, the selection of restoration materials should be based on proper optical characteristics in addition to biocompatibility and sufficient strength of materials.
Monolithic zirconia has been used in posterior region, especially for single crowns, in order to eliminate the veneer cracking, But Since monolithic zirconia are relatively new, few randomized, controlled clinical studies have evaluated their success. There is only one study identified regarding the performance of monolithic ceramic restorations bonded to Ti inserts, investigating the clinical outcome of using monolithic or modified monolithic zirconia implant-supported single crowns and comparing outcomes and complications of metal-ceramic and monolithic or modified monolithic zirconia implant supported single crowns.
More clinical studies to evaluate the performance of CAD/CAM monolithic implant-supported restorations bonded to Ti inserts and bases and compare their survival, success and complication rates with other restorative options \[with a mean follow-up period of at least 5 years are required for a meaningful interpretation of the survival and complication rate .
So this study aims to investigate outcomes and complications of implant supported modified monolithic zirconia and metal-ceramic single crowns in the posterior region of the mouth.
The null hypothesis is that there is no difference between modified monolithic zirconia and metal-ceramic posterior implant-supported SCs in prosthetic complication rates.
Who can participate
Age range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* · Participants will be required to sign informed consents prior to inclusion in the study.
* Aged between 21 to 55 years, with no contraindications to dental treatment.
* Need implant supported single crown in the maxillary and/or mandibular premolar and/or molar area
* No systemic disease.
* No signs of bruxism.
* Full-mouth plaque scores and full-mouth bleeding scores of \<25%
* Good overall dental health, no active caries, no active periodontal disease, and periodontal pocket depths not greater than 4 mm.
* Adequate bone height and width at areas of proposed implant sites
* Adequate interocclusal distance to accommodate the prosthesis
* Space width with mesial -distal width of at least 6 mm.
* Good oral hygiene and compliance with oral hygiene instructions as determined by the amount of plaque present on tooth surfaces
* Thick or medium gingival biotype.
* Bilateral one missing tooth being a premolar or molar in the maxilla or mandible with adjacent natural teeth.
* Fixed teeth opposing the edentulous area and a full complement of teeth or restored teeth in all other areas.
Exclusion Criteria:
* Systemic disease
* Pregnant and lactating women
* Unwilling to receive radiographs
* Presence of clinically active periodontal disease as expressed by probing pocket depths 4 mm in combination with bleeding on probing
* Presence of peri-apical lesions or any other abnormalities in the region as detected on a radiograph.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Screw loosing
Timeframe: 5 years
2
Marginal integrity
Timeframe: 5 years
3
chipping of veneering ceramic
Timeframe: 5 years
4
occlusal roughness
Timeframe: 5 years
5
framework fracture
Timeframe: 5 years
Trial details
NCT IDNCT04355325
SponsorJordan University of Science and Technology