RECRUITING

Immediate Versus Delayed Loading of Maxillary Overdenture Implants

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

Immediate Versus Delayed Loading of Maxillary Overdenture Implants

Quick Facts

Study Start:2023-02-01

Study Completion:2028-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06038487

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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).

Inclusion Criteria

Exclusion 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

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).

Contacts and Locations

Study Contact

Elysha Pomerantz, DMD

CONTACT

216-368-4412

emp142@case.edu

Principal Investigator

Gian P Schincaglia, DDS, PhD

PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Study Locations (Sites)

Case Western Reserve University Department of Periodontics

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: Case Western Reserve University

Gian P Schincaglia, DDS, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-02-01

Study Completion Date2028-02-01

Study Record Updates

Study Start Date2023-02-01

Study Completion Date2028-02-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Implant Complication