Actively Recruiting
Changes in Microbial Status From Dentate to Edentulous and After Dental Implant Placement in Severe Periodontitis Patients
Led by Case Western Reserve University · Updated on 2025-06-04
12
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to analyze changes in the oral microbiome during the transition from having some natural teeth (partial dentition) to being fully without teeth (edentulous), and following dental implant placement in people with severe periodontitis. The study evaluates how different implant materials and surfaces affect these microbiome changes. It also seeks to determine variability in these changes to help design future long-term studies. Participants will receive dental implants using one of two types: Intra-Lock Fusion Implants or Tapered Pro Implants. The study includes multiple visits: initial screening and full mouth examination, microbial sampling before tooth extraction, implant diagnostics with imaging, implant placement followed by healing and uncovering, and restorative connection. Microbial samples will be collected at several points from oral mucosa, tongue, and implant sites to assess microbiome shifts. During the study, participants undergo examinations including probing depth, clinical attachment, bleeding on probing, and X-rays at different visits. Microbial samples are collected and preserved for detailed genetic analysis. The main outcomes measured are changes in oral microbiome composition in dentate, edentulous, and post-implant states, along with differences between implant types. The study duration averages 24 months, with ongoing monitoring and data collection throughout this period.
CONDITIONS
Brief Title
Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 21 years of age
- Diagnosis of Stage III or IV periodontitis based on full mouth probing and x-rays
- Planned full mouth tooth extraction and replacement with dental implants
- Rehabilitation with implant-supported restorations in upper and/or lower jaw
- At least two implants available for examination
- No bone augmentation required
You will not qualify if you...
- Conditions requiring chronic routine prophylactic use of antibiotics
- Conditions requiring prolonged use of steroids
- History of leukocyte dysfunction or deficiencies
- Bleeding disorders
- History of cancer requiring radiation or chemotherapy
- Metabolic bone disorders
- Uncontrolled endocrine disorders
- Use of investigational drugs or devices within 30 days prior to implant surgery
- Alcoholism or drug abuse
- HIV infection
- Conditions preventing study completion or interfering with results, including non-compliance
- Local inflammation or mucosal diseases like erosive lichen planus
- History of local irradiation therapy
- Osseous lesions
- Active oral infections other than periodontitis
- Persistent intraoral infections such as suppuration or fistula tracks
- Other mucosal diseases affecting participation or analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo full mouth tooth extractions and provide baseline microbial samples before extraction. An immediate denture may be provided.
1 visit (in-person)
Duration - 3 to 4 months
Participants attend diagnostic appointments for implant placement preparation, including imaging and provisional denture adjustments.
Multiple visits (in-person) over 3 to 4 months
Duration - 1 day
Participants receive dental implants with microbial samples collected immediately before placement. Implants undergo a two-stage healing process.
1 visit (in-person)
Duration - 14 days after implant placement
Participants return for follow-up and suture removal 14 days after implant placement.
1 visit (in-person)
Duration - 3 to 4 months
Participants undergo a second surgery to uncover implants and connect abutments, followed by healing.
1 visit for uncover surgery plus follow-up visit for suture removal
Duration - 1 day
Permanent abutments are connected to implants, microbial samples are collected, and implant health measurements are recorded.
1 visit (in-person)
Duration - 12 months
Participants attend follow-up visits at 6 and 12 months after implant loading for microbial sampling and implant health assessments.
2 visits (in-person) at 6 and 12 months post-loading
Trial Site Locations
Total: 1 location
1
Case Western Reserve University Department of Periodontics
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
G
Gian Pietro Schincaglia, DDS,PhD
E
Elysha Pomerantz, DMD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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