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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05179746
Other study ID # Electrolytic cleaning
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date September 1, 2024

Study information

Verified date June 2022
Source University of Lisbon
Contact Vanessa Rocha Rodrigues, Dr
Phone 919950890
Email vanessa_15_rodrigues@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the outcomes of non-surgical therapy of peri-implantitis with the adjunctive use of electrolytic cleaning (Galvo Surge®). The proposed protocol, focused on the non-surgical treatment of peri-implantitis, will result in a higher percentage of subjects with disease resolution (probing depts ≤ 5mm, absence of BOP and/or SOP and no further bone loss) at 1 year of follow-up.


Description:

The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher reduction of probing depth than the control group. The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher radiographic bone fill of the peri-implant defect than the control group. The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a lower count of peri-implant pathogens than the control group.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date September 1, 2024
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible; 2. Presence of Peri-implantitis; 3. No implant mobility; 4. Treated periodontal disease; 5. No systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes, osteoporosis, bisphosphonate medication). 6. Non-smoker or light smoking status in smokers (<10 cigarettes/day). Exclusion Criteria: (1) Pregnant, lactating women and non-collaborating patients will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Implants are decontaminated with electrolytic cleaning
Implants are decontaminated with electrolytic cleaning
Implants are decontaminated without electrolytic cleaning
Implants are decontaminated without electrolytic cleaning

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Lisbon

Outcome

Type Measure Description Time frame Safety issue
Primary Probing pocket depth Will be calculated as the distance from the gingival peri-implant margin to the bottom of the peri-implant pocket (Mombelli & Lang, 1994). Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months
Primary Recession will be measured as the distance from the free marginal mucosa to the most apical portion of the crown. Assessing the change of recession from baseline at 3 months, 6 months and 12 months
Primary Clinical attachment level will be calculated as the sum of PPD and REC (distance from the most apical portion of the crown to the bottom of the periodontal pocket) Assessing the change from clinical attachment level from baseline at 3 months, 6 months and 12 months
Primary Bleeding on probing will be assessed dichotomously in six sites per implant (Heitz-Mayfield, 2008). Assessing the change from bleeding on probing from baseline at 3 months, 6 months and 12 months
Primary Radiographic Parameters Radiographic analysis through orthopantomography, periapical intraoral radiographs according to the parallelometric technique (using a silicone bite record so that the radiographs are parallelized and comparable to each other in different timepoints, checking in millimeters the increase or decrease in bone loss). Assessing the change of the radiographic parameters from baseline at 3 months, 6 months
Secondary Microbiological Parameters A sterilized paper tip from the microbiological kit will be introduced in the periimplantitis pocket, remaining in the same position for 10 seconds. After collecting the sample, the paper tip will be placed in an individual transfer tube, properly identified. Afterwards, the sample will be sent to the laboratory, where a polymerase chain reaction (PCR) test is performed to identify the following bacteria - A. actinomycetemcomitans, T. forsythia, T. denticola, P. gingivalis, P. intermedia and F. nucleatum. Assessing the change of the microbiological parameters from baseline at 3 months, 6 months
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