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Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement

Case Western Reserve University · NCT06149585

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
12
US sites recruiting
1
Study start
August 16, 2023
Record last updated
July 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The objectives of this study are to analyze the oral microbiome modulations occurring during the transition from partial (with some residual teeth) to full edentulous (without remaining teeth) status and implant placement in subjects affected by severe periodontitis; to evaluate if microbiome changes in relation to the used of different implant material/surface; and to assess the variance of the changes to determine the sample size for future longitudinal prospective studies.

Being studied: Microbial Sampling

Conditions: Edentulous Mouth; Periodontal Diseases; Periodontitis, Adult; Microbial Colonization

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • At least 21 years of age
  • Diagnosis of Stage III or IV periodontitis based on full mouth probing and full mouth x-rays
  • Planned for full mouth extraction and replacement by dental implants.
  • Rehabilitation with Implant supported restorations either maxilla and/ or mandible.
  • At least 2 implants available for examination.
  • No bone augmentation required.

Exclusion Criteria

  • Conditions requiring chronic routine prophylactic use of antibiotics.
  • Conditions requiring prolonged use of steroids.
  • History of leukocyte dysfunction and deficiencies
  • Bleeding disorders
  • History of neoplastic disease requiring use of radiation or chemotherapy
  • Metabolic bone disorders
  • Uncontrolled endocrine disorder
  • Use of any investigational drug or device within the 30 day period prior to implant surgery.
  • 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

  • Local inflammation
  • Mucosal disease such as erosive lichen planus
  • History of local irradiation therapy
  • Osseous lesion.
  • Active infection with suppuration or fistula track.
  • Persistent intraoral infection different than periodontitis

Recruiting US locations

  • Case Western Reserve University Department of Periodontics

    Cleveland, OH 44106

    Site contact: Gian Pietro Schincaglia, DDS, PhD · 216-368-4412 · gxs486@case.edu

Study contacts (from the official record)

  • Gian Pietro Schincaglia, DDS,PhD · 216-368-4412 · gxs486@case.edu
  • Elysha Pomerantz, DMD · 216-368-4412 · emp142@case.edu
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Changes in Microbial Status From Dentate, Edentulous and After… (NCT06149585) | Bored Studies