Recruiting

Immediate vs. Delayed

Sponsor:

Case Western Reserve University

Code:

NCT06038487

Conditions

Implant Complication

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Immediate loading of maxillary implant overdenture

Delayed loading of maxillary implant overdenture

Study Details

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

Study ID

NCT06038487

Start date

Feb 1, 2023

Status verified date

May, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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 Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Elysha Pomerantz, DMD

216-368-4412emp142@case.edu

Locations

Case Western Reserve University Department of Periodontics

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Gian Pietro Schincaglia, DDS, PhD

216-368-4412gxs486@case.edu

Elysha Pomerantz, DMD

216-368-4412emp142@case.edu

More Information

Sponsor

Case Western Reserve University

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-05-20.