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Compares treatment options for Implant Complication
Official title Immediate Versus Delayed Loading of Maxillary Overdenture Implants
ClinicalTrials.gov ID: NCT06038487
What this study is testing
- What it's testing
- The purpose of the study is to evaluate the radiographic, clinical and patient-centered outcomes of implant-retained immediately-loaded maxillary complete dentures in comparison to delayed loading approach by primarily evaluating radiographic bone loss of dental implants placed in the maxilla over 36 months
- Time commitment: about 36 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older. Healthy volunteers may be eligible.
You may be able to join if
- Males and females must be at least ≥ 21 years of age
- Fully edentulous maxilla
- The implant site has to be healed for at least 4 months after extraction
- Wearing complete dentures deemed adequate
- Orthopantomogram available (OPT)
You likely can't join if
- Conditions requiring chronic routine prophylactic use of antibiotics
- Conditions requiring prolonged use of steroids
- History of leukocyte dysfunction and deficiencies
- Bleeding disorders
- History of neoplastic disease requiring use of radiation or chemotherapy
- Metabolic bone disorders
See the full eligibility criteria
- Males and females must be at least ≥ 21 years of age
- Fully edentulous maxilla
- The implant site has to be healed for at least 4 months after extraction
- Wearing complete dentures deemed adequate
- Orthopantomogram available (OPT)
- Adequate amount of bone at least at the 2nd premolar position to house at minimum a 3.5 x 10 mm BLX-Roxolid implant
- No bone grafting required
- Implant IT ≥ 20 N/cm
- Conditions requiring chronic routine prophylactic use of antibiotics
- Conditions requiring prolonged use of steroids
- History of leukocyte dysfunction and deficiencies
- Bleeding disorders
- History of neoplastic disease requiring use of radiation or chemotherapy
- Metabolic bone disorders
- Uncontrolled endocrine disorder
- Use of any investigational drug or device within the 30-day period prior to implant surgery
- Vaping, Tobacco Chewing or Smoking more than 10 cigarettes a day
- Alcoholism or drug abuse
- Patient infected with HIV
- Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as as history of non-compliance, unreliability.
- Local inflammation including untreated periodontitis
- Mucosal disease such as erosive lichen planus
- History of local irradiation therapy
- Osseous lesion
- Severe bruxism and clenching habits
- Active infection with suppuration or fistula track
- Persistent intraoral infection
- Lack of primary stability \<20Ncm. In this instance, the patient must be withdrawn and treated according to the standard protocol.
- Inadequate oral hygiene or unmotivated home care.
- Bone grafting needed
- Inadequate bone volume for implants insertion as measured on the pre-treatment cone beam computed tomography (CBCT).
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.