Immediate Versus Delayed Loading of Maxillary Overdenture Implants

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT06038487
Status
Recruiting
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Conditions

  • Implant Complication

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Immediate loading of maxillary implant overdenture — PROCEDURE
    The denture will be immediately connected to the implants. The abutment screw will be torqued at 15 Ncm. The Novaloc cap attachments will be picked up intra-orally using cold curing resin. To avoid contact of the resin with the surgical wound, a circular portion of a sterile rubber dam sheet will be adapted on the cap attachment once placed on the abutment during the pickup procedure. Occlusion is then checked and adjusted if necessary as well as the adaptation on the residual ridges and the patient dismissed. The patients in the test group will be instructed not to remove the prosthesis for one week.
  • Delayed loading of maxillary implant overdenture — PROCEDURE
    A 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 described for the test group. The abutment screw will be torqued at 35 Ncm. As post-surgical instructions, the patients will be asked not to brush the operated areas and to rinse instead with 0,12% chlorhexidine solution twice a day for 1 minute for 14 days. Pain control is provided with 400 mg ibuprofen, as needed. Soft diet is recommended for 2 weeks. The patients in the control group will be asked not to wear the denture for 7 days.

Study Details

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

Key Dates

Start date
Feb 1, 2023
Status verified
May 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Test - IL ( Immediate Loading)
    The maxillary denture will be immediately connected to the implants on the day of the surgery
  • Active Comparator: Control - DL ( Delayed Loading)
    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.

Primary Outcome Measure

Radiographic bone level of changes of implants [ Time Frame: 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Western Reserve University Department of PeriodonticsClevelandOhio44106
Gian Pietro Schincaglia, DDS, PhD
[email protected]
216-368-4412
Elysha Pomerantz, DMD
[email protected]
216-368-4412

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By research site
Case Western Reserve University Department of Periodontics· Cleveland, OH

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