Chitosan Brushes vs Air-Abrasive Devices on Peri-implant Mucositis Treatment: A Randomized Clinical

February 24, 2024 updated by: Alper Gultekin, Istanbul University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with single implants and single cemented crowns with peri-implant mucositis on their posterior teeth (Premolars and molars) Regular peri-implant mucositis treatment with air-abrasive device and a new method with labrida bioclean brush for cleaning the infection.

Experimental procedures and follow-ups 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.

The number of cases to be taken in total, 12 cases, was determined as 48. There will be 54-55 cases with 10% drop out share.

GPOWER PROTOCOL F tests - ANOVA: Repeated measures, between factors Analysis: A priori: Compute required sample size Input: Effect size f = 0.4982302 α err prob = 0.05 Power (1-β err prob) = 0.95 Number of groups = 4 Number of measurements = 4 Corr among rep measures = 0.5 Output: Noncentrality parameter λ = 19.0643199 Critical F = 2.8164658 Numerator df = 3.0000000 Denominator df = 44.0000000 Total sample size = 48 Actual power = 0.9529658 For the results; Data will be analyzed with IBM SPSS V23. Repeated measures analysis of variance will be used to analyze quantitative data. For multiple comparisons, the Bonferroni test will be used. Analysis results will be presented as mean and standard deviation for quantitative data, and frequency and percentage for categorical data. The signifcance level will be taken as p<0.05.

Peri-implant mucositis is the last reversible stage before peri-implantitis. Treatment of the disease at this stage is very important. When treated, bone loss around the implant will be prevented and implant survival will be prolonged.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34080
        • Recruiting
        • Istanbul University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Presence of peri-implant mucositis around at least one implant,
  • Being over 18 years old,
  • Being psychologically suitable,
  • The teeth adjacent to the relevant implant are natural teeth,
  • Having at least 1 implant in the maxillary or mandibular posterior region (teeth 4, 5, 6 and 7) and a cemented prosthesis that is not connected to other implants or teeth as its superstructure,
  • Probing depth longer than 3 mm and shorter than 5 mm,
  • Evidence of bleeding is required on probing.

Exclusion Criteria:

  • Pregnancy
  • History of chemotherapy and/or radiotherapy received in the past or currently being received,
  • Bone loss around the implant,
  • Presence of an implant in the area adjacent to the relevant implant,
  • Dentures combined with other implants or teeth,
  • Screw-retained prostheses
  • Uncontrolled diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ML
Patients with mini platform implants to be treated with Labrida Bioclean
Procedure: Labrida BioClean
Debriding the tissue around the implant with Labrida Bioclean
Experimental: RL
Patients with regular platform implants to be treated with Labrida Bioclean
Procedure: Labrida BioClean
Debriding the tissue around the implant with Labrida Bioclean
Active Comparator: ME
Patients with mini platform implants to be treated with Air-Flow Devices (EMS Handy 3.0 Perio Premium)
Procedure: EMS Handy 3.0 Perio Premium
Debriding the tissue around the implant with Air-Flow Device
Active Comparator: RE
Patients with regular platform implants to be treated with Air-Flow Devices (EMS Handy 3.0 Perio Premium)
Procedure: EMS Handy 3.0 Perio Premium
Debriding the tissue around the implant with Air-Flow Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Depth
Time Frame: First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on Probing
Time Frame: First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

February 15, 2025

Study Registration Dates

First Submitted

February 24, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Estimated)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IU-DHF-AG-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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