Non-Surgical Treatment of Peri-Implantitis With Ultrasonic Carbon Tip

March 9, 2025 updated by: Berceste Guler, Kutahya Health Sciences University

A Comparison of Two Different Mechanical Interventions in Non-Surgical Peri-implantitis Treatment

As the frequency of dental implants increases, the incidence of complications and peri-implant diseases also increases. Early diagnosis and treatment of the disease is important to prevent consequences up to implant loss. Non-surgical treatment is the recommended treatment in the first stage due to its shorter duration and low morbidity rate. Non-surgical treatment of peri-implantitis provides clinical improvements such as reduced bleeding on probing (20-50%) and, in some cases, reduced pocket depth (≤ 1 mm). This study aims to clinically and radiographically compare two different mechanical treatments in patients with mild and moderate peri-implantitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

60 patients with at least one implant with mild to moderate peri-implantitis, defined as 2-4 mm radiographic reduced bone level, bleeding index (BI) ≥ 2, and probing pocket depth (PPD) ≥ 4 mm will be randomly allocated to test and control groups, receiving titanium curettes or ultrasonic Carbon tips debridement, respectively. Treatment was performed at baseline. Plaque index (PI), gingival index (GI), Periodontal pocket depth (PD), Bleeding on probing (BOP) gingival recession (GR) and Clinical attachment level (CAL) will be measured at four sites per implant and recorded by examiner at baseline, one, three, six and twelve months. Pus will be recorded as present/not present. The radiographic marginal bone level changes will be calculated at baseline, third months, sixth months and 12 months.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

  • Turkey
      • Kütahya, Turkey, 43100
        • Recruiting
        • Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
        • Contact:
          • Berceste Güler

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  1. Adult patients (≥18 years old)
  2. Systemically healthy (ASA class 1 and ASA class 2)
  3. Full-mouth plaque scores ≤20%
  4. Implant had been in function for more than 6 months
  5. Absence of plaque around the implant
  6. Consent to complete all follow-up visits

Exclusion criteria:

  1. Mobile implant
  2. Overhanging restorations that prevent access to the implant for clinical measurements
  3. Unresolvable technical complications that can cause peri-implantitis
  4. Presence of active periodontal disease
  5. Implants with a history of peri-implantitis treated using graft materials
  6. Use of drugs that cause gingival hyperplasia
  7. Systemic antibiotic use in the last 3 months
  8. Acute and chronic medical conditions that prevent the patient from participating in the study
  9. Presence of uncontrolled severe peri-implantitis from neighbouring implants
  10. History of radiotherapy in the head and neck region
  11. Receiving acute chemotherapy
  12. Current corticosteroid therapy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasonic Carbon
Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment
Procedure: Ultrasonic Carbon Tip
Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment
Active Comparator: Titanium
Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment
Procedure: Titanium Curette
Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal depth decrease
Time Frame: Baseline to 12th month
Periodontal pocket depth (PD) decreasing baseline to 12th month
Baseline to 12th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
marginal bone level changes
Time Frame: Baseline to 12th month
Marginal bone level changes will be calculated at standardized periapical radiography
Baseline to 12th month

Collaborators and Investigators

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

Sponsor

Kutahya Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 21, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-13/01

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

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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