Health TrialsbyHealthPanel

Immediate Versus Delayed Loading of Maxillary Overdenture Implants

ConditionImplant Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorCase Western Reserve University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Conditions requiring chronic routine prophylactic use of antibiotics

Conditions requiring prolonged use of steroids

History of leukocyte dysfunction and deficiencies

Bleeding disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate loading of maxillary implant overdenture

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Test - IL ( Immediate Loading)Experimental treatment 1 intervention
Group B: Control - DL ( Delayed Loading)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Radiographic bone level of changes of implants

The primary objective of this study is to evaluate radiographically at 6, 12, 24 and 36 months post-loading the performance of the BLX Roxolid™ implants placed using a flapless guided surgery and immediately loaded with a maxillary overdenture versus delayed loading 3 months after surgical placement. The outcome will be evaluated using peri-implant, radiographic bone level changes measure in milimeters from standardized radiographs from baseline to 6, 12, 24 and 36 months post implant placement.

Time frame
36 months

Secondary outcomes

1

Pocket Depth of the peri-implant mucosa

Will be recorded as a whole number in milimeters at 6 sites per implant

Time frame
36 months
2

Bleeding on probing of the peri-implant mucosa

Will be recorded as a absence or presence of bleeding on probing at 6 sites per implant

Time frame
36 months
3

Implant survival

Implant survival at 6, 12, 24 and 36 months will be recorded as implant present or implant lost

Time frame
36 months
4

Complications

The nature of surgical and prosthetic complications. For example, fracture of denture or loosening of implant abutment.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Western Reserve University

Lead sponsor

Institut Straumann AG

Collaborator

Source ClinicalTrials.gov
Apply now