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NCT Number: NCT06514677

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Kütahya, 43100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Berceste Güler

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ultrasonic Carbon Tip

Procedure

Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment

Titanium Curette

Procedure

Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment

Primary outcomes

  1. Periodontal depth decrease

    Time frame: Baseline to 12th month

    Periodontal pocket depth (PD) decreasing baseline to 12th month

Secondary outcomes

  1. marginal bone level changes

    Time frame: Baseline to 12th month

    Marginal bone level changes will be calculated at standardized periapical radiography

Study contacts

Contact information is provided by the study sponsor or research team.

Berceste Guler Ayyildiz, d

CONTACT

[email protected]

+90 (274) 260 00 43

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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