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Procedure

Immediate vs Delayed Loading of Dental Implants for Implant Complications

N/A
Recruiting
Led By Gian P Schincaglia, DDS, PhD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fully edentulous maxilla
Adequate amount of bone at least at the 2nd premolar position to house at minimum a 3.5 x 10 mm BLX-Roxolid implant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial compares two approaches for maxillary implants to determine how they affect radiography, clinical outcomes and patient satisfaction over 36 months.

Who is the study for?
This trial is for adults over 21 who have no teeth in their upper jaw, are currently using dentures that fit well, and have enough bone for dental implants without needing a bone graft. People with HIV, ongoing infections or inflammation, bleeding or metabolic bone disorders, poor oral hygiene, history of certain cancers or radiation therapy to the jaw can't participate.Check my eligibility
What is being tested?
The study compares two methods of fitting complete dentures on implants in the upper jaw: one where the denture is loaded immediately onto newly placed implants (immediate loading), and another where there's a waiting period before loading the denture (delayed loading). The main focus is on how much bone loss occurs around the implant over three years.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, swelling, bruising, infection risk increase around implants and possible issues with how well the overdenture fits initially.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have no natural teeth in my upper jaw.
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I have enough bone for a specific dental implant.
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I am 21 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiographic bone level of changes of implants
Secondary outcome measures
Bleeding on probing of the peri-implant mucosa
Complications
Implant survival
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Test - IL ( Immediate Loading)Experimental Treatment1 Intervention
The maxillary denture will be immediately connected to the implants on the day of the surgery
Group II: Control - DL ( Delayed Loading)Active Control1 Intervention
At the time of surgery, the cover screw will be seated on the implants and the flap will be sutured for a submerged healing. After 3 months of healing the implants will be exposed and connected to the prosthesis following the same prosthetic protocol as the test group.

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
299 Previous Clinical Trials
246,564 Total Patients Enrolled
Institut Straumann AGIndustry Sponsor
52 Previous Clinical Trials
2,621 Total Patients Enrolled
3 Trials studying Implant Complication
83 Patients Enrolled for Implant Complication
Gian P Schincaglia, DDS, PhDPrincipal InvestigatorCase Western Reserve University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to enrolling new participants?

"Affirmative, the clinicaltrials.gov portal reveals that this medical research is currently recruiting candidates. It was initially launched on February 1st 2023 and its details have been recently amended as of September 8th 2023. This study is searching for 18 participants from a single location."

Answered by AI

How many participants are being treated in this research study?

"Correct. According to the data posted on clinicaltrials.gov, this medical experiment is actively seeking participants with recruitment beginning February 1st 2023 and the most recent update being September 8th 2023. The team needs 18 individuals from a single site for their study."

Answered by AI

Who else is applying?

What site did they apply to?
Case Western Reserve University Department of Periodontics
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Because I have a top plate but I’d really like to have implants instead. I've always had a very nice smile, I even had braces as a kid.. in 2021, six of my front upper teeth were pulled, . Clinical trials would help me regain my social confidence and also help others.
PatientReceived 2+ prior treatments
I feel im a great canidate, I need a full upper jaw implants. I love to help progress dental surgery for the future to be more effective for patients. Not having upper teeth is hard to chew, I hope this trial can help for future proceedings .
PatientReceived 1 prior treatment
I feel I'm a great candidate, I need a full upper jaw implants. I love to help progress dental surgery for the future to be more effective for patients. Not having upper teeth is hard to chew, I hope this trial can help for future proceedings .
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Immediate Versus Delayed Loading of Maxillary Overdenture Implants
Gian Schincaglia 2023. "Immediate Versus Delayed Loading of Maxillary Overdenture Implants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06038487.
~7 spots leftby Feb 2025
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