Assessment of the Effects of Different Implant Abutment Occluding Materials on Dental Implant Health Parameters and Microbiology

Peri-Implantitis Clinical Trial

Official title:

An In Vivo Assessment of the Effects of Using Different Implant Abutment Occluding Materials on Implant Microleakage and the Peri-Implant Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625597
• Other study ID #: 409069
• Status: Completed
• Phase: N/A
• First received: November 29, 2015
• Last updated: December 7, 2015
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to determine what effect, if any, do different dental materials used to seal the prosthetic screw channels of implant supported restorations have on dental implant health parameters and microbiology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Fully edentulous patient

• Patient has at least one arch restored with a full-arch dental supported prosthesis

Exclusion Criteria:

• poor oral hygiene and motivation (as determined with prosthesis in place)

• uncontrolled diabetes

• pregnant or lactating

• substance abusers

• current smokers

• psychiatric problems or unrealistic expectations

• acute infection in the area intended for implant sealing

• positive to HIV and hepatitis B and C

• affected by autoimmune diseases

• under chronic treatment with steroids or non-steroidal anti-inflammatory drugs.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Implant Failed
• Dental Implant Failure Nos
• Peri-Implantitis

Intervention

Device:
• Cotton Pellet

• Polytetrafluoroethylene Tape

• Synthetic Foam

• Polyvinylsiloxane

Locations

Country	Name	City	State
United States	School of Dental Medicine of Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing Depth		6 months	No
Secondary	Gingival Index		6 Months	No
Secondary	Plaque Index		6 Months	No
Secondary	Microbial DNA Composition of the Peri-Implant Sulcus Assessed By PCR and Sequencing Protocols		6 Months	No
Secondary	Microbial DNA Composition on the Dental Materials Assessed By PCR and Sequencing Protocols		6 Months	No