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

NCT06287957 | Recruiting

• 1 other identifier: IU-DHF-AG-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peri-implant Mucositis; Peri-Implantitis; Bleeding on Probing; Periodontal Pocket

Keywords

peri-implant mucositis; Labrida Bioclean; Air-flow; Chitosan Brush; Peri-implantitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bleeding on Probing

  First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure

Other Outcomes (1)

• Plaque Index

  First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure

Study Arms (4)

ML

EXPERIMENTAL

Patients with mini platform implants to be treated with Labrida Bioclean

Procedure: Labrida BioClean

RL

EXPERIMENTAL

Patients with regular platform implants to be treated with Labrida Bioclean

Procedure: Labrida BioClean

ME

ACTIVE COMPARATOR

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

RE

ACTIVE COMPARATOR

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

Interventions

Labrida BioClean PROCEDURE

Debriding the tissue around the implant with Labrida Bioclean

ML; RL

EMS Handy 3.0 Perio Premium PROCEDURE

Debriding the tissue around the implant with Air-Flow Device

ME; RE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Fatih, 34080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis; Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: There are going to be 4 treatment groups. Group 1: Mini Implant Platform treated with Labrida Bioclean Group 2: Regular Implant Platform treated with Labrida Bioclean Group 3: Mini Implant Platform treated with Air-Flow Device Group 4: Regular Implant Platform treated with Air-Flow Device

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 1, 2024
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: February 15, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)