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Immediate Versus Delayed Loading of Maxillary Overdenture Implants

Sponsor: Case Western Reserve University • ClinicalTrials.gov ID: NCT06038487

Registry updated: 2026-09-15

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Description

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

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.
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.

Eligibility criteria

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).

Conditions

Implant Complication

Locations

Case Western Reserve University Department of Periodontics — Cleveland, Ohio, United States
West Virginia University — Morgantown, West Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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