Immediate Versus Delayed Loading of Maxillary Overdenture Implants

NCT06038487 | Recruiting

• 1 other identifier: STUDY20221174
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Implant Complication

Keywords

Implant Overdenture; Immediate loading; Delayed loading; Maxillary Overdenture; Novaloc Retention System; Guided Implants; Immediate vs Delayed loading; Implant-supported overdenture

Outcome Measures

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.

  36 months

Secondary Outcomes (5)

• Pocket Depth of the peri-implant mucosa

  36 months

• Bleeding on probing of the peri-implant mucosa

  36 months

• Implant survival

  36 months

• Complications

  36 months

• Patient-centered outcomes

  36 months

Study Arms (2)

Test - IL ( Immediate Loading)

EXPERIMENTAL

The maxillary denture will be immediately connected to the implants on the day of the surgery

Procedure: Immediate loading of maxillary implant overdenture

Control - DL ( Delayed Loading)

ACTIVE COMPARATOR

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

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.

Test - IL ( Immediate Loading)

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.

Control - DL ( Delayed Loading)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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)
• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Institut Straumann AG: collaborator

Study Sites (1)

Case Western Reserve University Department of Periodontics

Cleveland, Ohio, 44106, United States

RECRUITING

Study Officials

• Gian P Schincaglia, DDS, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elysha Pomerantz, DMD

CONTACT

216-368-4412; emp142@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Every patient will be given a participant identification number. An independent investigator, not involved with patient treatment, will generate the allocation list. Computer software will be used to randomize the participant identification numbers into one of the two groups. This information will be concealed in sealed opaque envelopes, which will be open after implants are placed. Neither the surgeon, nor the patient will be aware of the group assignment until after implant insertion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chair and Graduate Program Director

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

US (1)