Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without… (NCT06063876) | Clinical Trial Compass
By InvitationNot Applicable
Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty
United States30 participantsStarted 2023-09-05
Plain-language 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 implantoplasty (IP) compared to those treated without IP.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 sig…
What they're measuring
1
Changes in the modified Gingival Index (mGI) between 21 and 42 days