Immediate Versus Delayed Loading of Maxillary Overdenture Implants

May 19, 2026 updated by: Gian Schincaglia, Case Western Reserve University
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elysha Pomerantz, DMD
  • Phone Number: 216-368-4412
  • Email: emp142@case.edu

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University Department of Periodontics
        • Contact:
        • Contact:
          • Gian Pietro Schincaglia, DDS, PhD
          • Phone Number: 216-368-4412
          • Email: gxs486@case.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Males and females must be at least ≥ 21 years of age
  2. Fully edentulous maxilla
  3. The implant site has to be healed for at least 4 months after extraction
  4. Wearing complete dentures deemed adequate
  5. Orthopantomogram available (OPT)
  6. Adequate amount of bone at least at the 2nd premolar position to house at minimum a 3.5 x 10 mm BLX-Roxolid implant
  7. No bone grafting required
  8. Implant IT ≥ 20 N/cm

Exclusion Criteria:

  1. Conditions requiring chronic routine prophylactic use of antibiotics
  2. Conditions requiring prolonged use of steroids
  3. History of leukocyte dysfunction and deficiencies
  4. Bleeding disorders
  5. History of neoplastic disease requiring use of radiation or chemotherapy
  6. Metabolic bone disorders
  7. Uncontrolled endocrine disorder
  8. Use of any investigational drug or device within the 30-day period prior to implant surgery
  9. Vaping, Tobacco Chewing or Smoking more than 10 cigarettes a day
  10. Alcoholism or drug abuse
  11. Patient infected with HIV
  12. 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.
  13. Local inflammation including untreated periodontitis
  14. Mucosal disease such as erosive lichen planus
  15. History of local irradiation therapy
  16. Osseous lesion
  17. Severe bruxism and clenching habits
  18. Active infection with suppuration or fistula track
  19. Persistent intraoral infection
  20. Lack of primary stability <20Ncm. In this instance, the patient must be withdrawn and treated according to the standard protocol.
  21. Inadequate oral hygiene or unmotivated home care.
  22. Bone grafting needed
  23. Inadequate bone volume for implants insertion as measured on the pre-treatment cone beam computed tomography (CBCT).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test - IL ( Immediate Loading)
The maxillary denture will be immediately connected to the implants on the day of the surgery
Procedure: Immediate 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.
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.
Procedure: Delayed loading of maxillary implant overdenture
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiographic bone level of changes of implants
Time Frame: 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 measure in milimeters from standardized radiographs from baseline to 6, 12, 24 and 36 months post implant placement.
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pocket Depth of the peri-implant mucosa
Time Frame: 36 months
Will be recorded as a whole number in milimeters at 6 sites per implant
36 months
Bleeding on probing of the peri-implant mucosa
Time Frame: 36 months
Will be recorded as a absence or presence of bleeding on probing at 6 sites per implant
36 months
Implant survival
Time Frame: 36 months
Implant survival at 6, 12, 24 and 36 months will be recorded as implant present or implant lost
36 months
Complications
Time Frame: 36 months
The nature of surgical and prosthetic complications. For example, fracture of denture or loosening of implant abutment.
36 months
Patient-centered outcomes
Time Frame: 36 months
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
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Western Reserve University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut Straumann AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gian P Schincaglia, DDS, PhD, Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY20221174

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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