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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06287957
Other study ID # IU-DHF-AG-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date February 15, 2025

Study information

Verified date February 2024
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Bleeding on probing (0,1,2,3), plaque index (+,-) and pocket probing depth will be recorded for each visit. Before the procedure, the patient will be randomly assigned to one of four groups and records will be kept. In the frst visit of the patient, necessary actions will be taken according to the group to which the patient is assigned. The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements. The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements. The debrided area of both groups will be washed with sterile serum after the treatment. Patients will be called at the 2nd, 4th and 12th weeks and compared with the records kept.


Description:

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Study Design


Intervention

Procedure:
Labrida BioClean
Debriding the tissue around the implant with Labrida Bioclean
EMS Handy 3.0 Perio Premium
Debriding the tissue around the implant with Air-Flow Device

Locations

Country Name City State
Turkey Istanbul University Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Plaque Index Plaque index will be recorded around the implant (+,-). First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure
Primary Probing Depth Probing depth will be recorded for all around the implant on each visit of the patient. One of the inclusion criterias is 3 to 5 mm probing depth around the implant. First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure
Secondary Bleeding on Probing Bleeding on probing will be recorded on each visit of the patient (No bleeding 0, spot bleeding 1, Linear Bleeding 2, Bleeding all around 3). First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure
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