RECRUITING

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

Conditions

Edentulous Mouth Periodontal Diseases Periodontitis, Adult Microbial Colonization

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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 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.

Official Title

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

Quick Facts

Study Start:2023-08-16

Study Completion:2026-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06149585

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. 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.	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. 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

Inclusion Criteria

Exclusion 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.

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.
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

Contacts and Locations

Study Contact

Gian Pietro Schincaglia, DDS,PhD

CONTACT

216-368-4412

gxs486@case.edu

Elysha Pomerantz, DMD

CONTACT

216-368-4412

emp142@case.edu

Principal Investigator

Gian Pietro 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 Pietro 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 Date2023-08-16

Study Completion Date2026-05-01

Study Record Updates

Study Start Date2023-08-16

Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

Edentulous Mouth
Periodontal Diseases
Periodontitis, Adult
Microbial Colonization