Status:
ENROLLING_BY_INVITATION
Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty
Lead Sponsor:
University of Pittsburgh
Conditions:
Peri-implant Mucositis
Peri-Implantitis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This controlled clinical trial will assess clinically, immunologically, and microbiologically the healing of experimental peri-implant mucositis (PIM) lesions in implants treated previously with impla...
Detailed Description
The present parallel controlled clinical trial is designed as a 21-day experimental peri-implant mucositis, followed by a period of resolution of 21 days in healthy implants that were previously treat...
Eligibility Criteria
Inclusion
- Aged 18-80 years
- In good general health, (at least ASA 2)
- Previously treated implants must have probing depths (PD) ≤ 4 mm
- Previously treated implants must have \<50% bone loss around the implant of interest (assessed radiographically)
- Patients must have been treated previously for peri-implantitis with or without IP, with at least 1 thread or 2 mm of implant surface exposed in the oral cavity.
- Have little to no bacteria on the implant(s) of interest (modified Plaque Index of \<1) by Day 0
- Have healthy gums that do not bleed around the implant(s) of choice (modified Gingival index \<1) by Day 0
- Have evidence of stable bone levels around the treated implant for \> 6 months
Exclusion
- Active infectious diseases of any kind.
- Medical conditions which require premedication prior to dental treatments/visits.
- Pregnant women or planning to become pregnant (self-reported).
- Patients with congenital or metabolic bone disorders (ie. osteoporosis, vitamin D deficiency, parathyroid disease, etc.)
- Current heavy smokers: Subjects who have smoked more than 1 pack/day within 6 months of study onset (self-reported)
- Subjects with co-morbid conditions (i.e., uncontrolled diabetes, cardiovascular disease, impaired kidney function, heart murmur, rheumatic fever, bleeding disorder, hepatitis, tuberculosis, HIV) that would affect the study outcome or interpretation of study results will be excluded.
- Concomitant medications: Subjects on significant concomitant drug therapy for systemic conditions (i.e., Chronic anti-inflammatory medication, antibiotics, anticoagulants, any medication initiated \<3 months prior to the screening visit) will not be included in the study. Occasional short-term use (7-14 days) of analgesics or common cold medication is permitted. Such use of these medications will be reviewed and recorded by the Investigator.
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06063876
Start Date
September 5 2023
End Date
June 1 2026
Last Update
October 10 2025
Active Locations (1)
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1
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, United States, 15213