Status:

RECRUITING

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

Lead Sponsor:

Case Western Reserve University

Conditions:

Edentulous Mouth

Periodontal Diseases

Eligibility:

All Genders

21+ years

Brief Summary

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 ...

Detailed Description

The introduction of dental implants has significantly changed the treatment approach for prosthetic rehabilitation of partially and edentulous patients. In the last decades an increasing number of pat...

Eligibility Criteria

Inclusion

  • 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

  • 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.
  • 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
  • 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

Key Trial Info

Start Date :

August 16 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2027

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT06149585

Start Date

August 16 2023

End Date

May 1 2027

Last Update

June 4 2025

Active Locations (1)

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1

Case Western Reserve University Department of Periodontics

Cleveland, Ohio, United States, 44106