Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement
Launched by CASE WESTERN RESERVE UNIVERSITY · Nov 20, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how the bacteria in the mouth change when patients transition from having some teeth to having no teeth at all, and how this is affected by getting dental implants. The researchers want to understand how different types of implant materials might influence these changes, especially in patients with severe gum disease, known as periodontitis. By observing these changes, the study aims to gather important information that can help plan future research on dental health.
To be eligible for this trial, participants need to be at least 21 years old and diagnosed with advanced periodontitis, meaning they have significant gum disease. They should be planning to have all their teeth removed and replaced with dental implants. Participants should also have at least two implants that can be studied. However, there are certain health conditions, like needing long-term antibiotics or having specific infections, that would exclude someone from joining. If eligible, participants can expect to have their oral health monitored closely during the study, helping to improve understanding of dental health and implant success in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. At least 21 years of age
- • 2. Diagnosis of Stage III or IV periodontitis based on full mouth probing and full mouth x-rays
- • 3. Planned for full mouth extraction and replacement by dental implants.
- • 4. Rehabilitation with Implant supported restorations either maxilla and/ or mandible.
- • 5. At least 2 implants available for examination.
- • 6. No bone augmentation required.
- 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.
- • 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 history of non-compliance, unreliability.
- • Local Exclusion Criteria
- • 1. Local inflammation
- • 2. Mucosal disease such as erosive lichen planus
- • 3. History of local irradiation therapy
- • 4. Osseous lesion.
- • 5. Active infection with suppuration or fistula track.
- • 6. Persistent intraoral infection different than periodontitis
About Case Western Reserve University
Case Western Reserve University (CWRU) is a leading research institution located in Cleveland, Ohio, renowned for its commitment to advancing knowledge and improving health outcomes through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, CWRU integrates expertise from various fields, including medicine, engineering, and social sciences, to address complex health challenges. The university's clinical trial initiatives are designed to foster the development of novel therapies and interventions, ensuring rigorous scientific methodologies and ethical standards are upheld. CWRU is dedicated to translating research findings into tangible benefits for patients and communities, contributing significantly to the advancement of healthcare practices and policies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Patients applied
MD
SM
MB
TM

TL
TN
SW
AG
ER
Trial Officials
Gian Pietro Schincaglia, DDS,PhD
Principal Investigator
Case Western Reserve University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported