An interventional study of Immediate loading of maxillary implant overdenture and Delayed loading of maxillary implant overdenture in Implant Complication, sponsored by Case Western Reserve University. Recruiting at 2 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Treatment
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
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 from baseline to 6, 12, 24, and 36 months post-implant placement. The secondary objectives include evaluation of the condition of the peri-implant mucosa (pocket depth and bleeding on probing); Implant survival at 6, 12, 24, and 36 months; The nature and the frequency of surgical and prosthetic complications; Patient-centred outcomes (OHIP 14). An initial evaluation will be conducted to determine whether a patient meets the study inclusion criteria. This evaluation will include medical history, clinical examination, and radiographic examination (OPT). A pre-operative prosthetic evaluation of the existing prostheses will be made to establish their quality and the need for a new set of complete dentures before the implant placement. The maxillary denture will be used as a radiographic guide for the pre-treatment CBCT assessment. The tridimensional image obtained with the CBCT will be used for the surgical planning of the implant positioning using a dedicated implant planning software (coDiagnostix, Dental Wings Gbmh, Chemniz Germany) and a stereo-lithographic surgical guide will obtained using a 3D printer (Formlab 3B, Formlabs Inc. Somerville MA.). The implants will be inserted under local anesthesia, following consumption of prophylactic antibiotic medications consisting of 2 grams of amoxicillin 1 hour before the surgical procedure. If the patient is allergic to penicillin or penicillin derivatives, azithromycin or other classes of antibiotics will be administered according to ADA guidelines. The implant placement will be performed using the stereo-lithographic surgical guide. A small crestal incision and a minimal flap elevation will be performed in the location of the implant sites. The osteotomy site will be prepared following the drilling sequence provided by the manufacturer's surgical manual. The implant will be placed, and the maximum value of insertion torque (peak of insertion torque, IT) will be measured during the seating of the most coronal implant threads using the surgical unit (W\&H, Burmoos, Austria) and recorded as 20, 30, 40, 50 N/cm IT category. In case of IT lower than 20 N/cm the patient will be excluded from the study and the implant treatment will be completed following the standard delayed protocol. After implant placement, the patient will be randomly allocated to the test or control group. BLX Roxolid dental implants will be used, and length and size will be chosen based on the available bone volume. A minimum amount of bone at the 2nd premolar position to house a 3.5 x 10 mm BLX-Roxolid will be required. The patient will be randomly assigned to have their implants immediately loaded or conventionally loaded/delayed. The randomization will be computer-generated and the subject's assignment will be placed in a sealed envelope. On the day of surgery, after the implants are placed, the investigators will open the envelope to see which group the patient has been assigned to. If assigned to the test group, 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 is dismissed. If assigned to the control group, a cover screw will be seated on the implants and the flap will be sutured for 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 per 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. A soft diet is recommended for 2 weeks. The patients in the test group will be instructed not to remove the prosthesis for one week. The patients in the control group will be asked not to wear the denture for 7 days. Patients will be recalled at 1, 2, 4, 12 weeks, and 6, 12, 24, and 36 months after surgery. At the post-operative visit occlusion will be checked, as well as stability and retention of the prostheses and the need for any prosthetic maintenance. At 12 weeks the test group patient will have the abutment screw torqued at 35 Ncm. The control group patient will have the implant exposed and connected to Novaloc using a 35 Ncm torque. Periapical radiographs will be taken at abutment connection and 6, 12, 24, 36 months visit by paralleling technique using a Rinnâ (Dentsply Rinn, Elgin, Illinois, USA) film holder. The film holder will be indexed on the attachment so that the film position can be reproduced for the follow-up radiographs. All patient complaints or any complications resulting from a change in health status from baseline or any implant-related complications such as pain, paraesthesia, or peri-implant infection will be recorded as an adverse event in the CRF and will be monitored until the condition is resolved. OHIP-14 questionnaire will be administered at baseline, at 4 weeks post-surgery, and months 6, 12, 24, and 36 months.
Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
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The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The maxillary denture will be immediately connected to the implants on the day of the surgery
Procedure: Immediate loading of maxillary implant overdenture
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.
Procedure: Delayed loading of maxillary implant overdenture
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.
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.
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
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
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
Implant survival
Implant survival at 6, 12, 24 and 36 months will be recorded as implant present or implant lost
Time frame: 36 months
Complications
The nature of surgical and prosthetic complications. For example, fracture of denture or loosening of implant abutment.
Time frame: 36 months
Patient-centered outcomes
Patient-centered outcomes according to Oral Health Impact Profile-14 (OHIP 14). The subjects will answer questions about their dentures and the potential problems they encounter and will have answer options of "very often," "fairly often," "occasionally," "hardly ever," "never," or "don't know." "Never" is considered the best outcome
Time frame: 36 months
PDFs hosted by the registry, ClinicalTrials.gov.
Started Feb 2023 (actual). Primary completion is estimated for Feb 2027, 48 months after the start.
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