Recruiting

Observational Study

Sponsor:

Case Western Reserve University

Code:

NCT06149585

Conditions

Edentulous Mouth

Periodontal Diseases

Periodontitis, Adult

Microbial Colonization

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Microbial Sampling

Study Details

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

Study ID

NCT06149585

Start date

Aug 16, 2023

Status verified date

Jun, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion 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.

Exclusion Criteria:

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.

Local Exclusion Criteria

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

Study Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

Intra-Lock Fusion Implants

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

Tapered Pro Implants

These patients will receive Tapered Pro Implants during implant placement

Interventions

Microbial Sampling

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

Primary outcome measure

  • Oral microbiome composition changes in patients who are dentate, edentulous, and have dental implants [ Time Frame: Through study completion, an average of 24 months ]
  • Oral microbiome changes in two different implant platform types [ Time Frame: Through study completion, an average of 24 months ]

Central Contacts and Locations

Central contacts

Gian Pietro Schincaglia, DDS,PhD

216-368-4412gxs486@case.edu

Elysha Pomerantz, DMD

216-368-4412emp142@case.edu

Locations

Case Western Reserve University Department of Periodontics

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Gian Pietro Schincaglia, DDS, PhD

216-368-4412gxs486@case.edu

Elysha Pomerantz, DMD

216-368-4412emp142@case.edu

More Information

Sponsor

Case Western Reserve University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-07-01.