Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorCase Western Reserve University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Conditions requiring chronic routine prophylactic use of antibiotics.
Conditions requiring prolonged use of steroids.
History of leukocyte dysfunction and deficiencies
Bleeding disorders
Trial population
The study population will consist of patients with stage III or IV periodontitis who are patients at the Case Western Reserve University School of Dental Medicine in the Department of periodontitis who are seeking to remove all of their remaining teeth and replace the teeth lose to periodontal disease with dental implants
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Microbial Sampling
Other interventionPool microbial sampling will be performed and changes in the microbiome will be evaluated and compared for differences
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Intra-Lock Fusion Implants1 intervention
Group B: Tapered Pro Implants1 intervention
Trial outcomes
Primary outcomes
1
Oral microbiome composition changes in patients who are dentate, edentulous, and have dental implants
To analyze the oral microbiome modulations through DNA analysis of microbial samples 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
Time frame
Through study completion, an average of 24 months2
Oral microbiome changes in two different implant platform types
To evaluate if microbiome changes through DNA analysis of microbial samples in relation to the use of different implant material/surface
Time frame
Through study completion, an average of 24 monthsSecondary outcomes
1
Sample size
To assess the variance of the changes to determine the sample size for future longitudinal prospective studies
Time frame
Through study completion, an average of 24 monthsSponsors and contacts
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Source ClinicalTrials.gov