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

NCT06149585 | Recruiting

• 1 other identifier: STUDY20221051
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  Through study completion, an average of 24 months

• 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

  Through study completion, an average of 24 months

Secondary Outcomes (1)

• Sample size

  Through study completion, an average of 24 months

Study Arms (2)

Intra-Lock Fusion Implants

These patients will receive Intra-Lock Fusion Implants during implant placement

Other: Microbial Sampling

Tapered Pro Implants

These patients will receive Tapered Pro Implants during implant placement

Other: Microbial Sampling

Interventions

Microbial Sampling OTHER

Pool microbial sampling will be performed and changes in the microbiome will be evaluated and compared for differences

Intra-Lock Fusion Implants; Tapered Pro Implants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University Department of Periodontics

Cleveland, Ohio, 44106, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Separate pooled samples will be collected from 3 areas of the mouth: oral mucosa, tongue, Peri-implant sulci (when applicable). Surfaces will be swabbed for 30 seconds each with a single CatchAll™ Swab. Care will be taken to avoid contacting the teeth. The swab will be immediately swirled in 400 uL Tris-EDTA buffer, pressing the swab against the tube walls for 20 seconds to transfer the material to the solution. The swab will be then discarded. The procedure will be repeated, but this time swabs will be placed in 400 uL of RNA Cell Protect (Qiagen). Subgingival plaque collection: The subgingival plaque will be then sampled with a Gracey curette obtaining samples from all available surfaces, and placed in 400 uL of TE buffer or 400 uL RNA Cell Protect (Qiagen). Samples will be immediately transferred to a -80 degree C freezer until further processed.

MeSH Terms

Conditions

Mouth, Edentulous; Periodontal Diseases; Chronic Periodontitis; Communicable Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Gian Pietro Schincaglia, DDS,PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Pietro Schincaglia, DDS,PhD

CONTACT

216-368-4412; gxs486@case.edu

Elysha Pomerantz, DMD

CONTACT

216-368-4412; emp142@case.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 29, 2023
• Study Start: August 16, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

US (1)